FDA Drug Labels Sample

Source

api.fda.gov

Quality score: 80/100.

Initial recorded revision.

Current Source Files

• label.json 20260907135233-9f179e3cc9ea Provider source

Contract Versions

• 20260907135233-9f179e3cc9ea Copy YAML link

Current Open Data Contract YAML

Open raw YAML

dataset_id: fda-drug-labels
title: FDA Drug Labels Sample
description: FDA Drug Labels Sample discovered from api.fda.gov. Bounded source query
  (limit=100); completeness is not assumed.
source_name: api.fda.gov
source_url: https://api.fda.gov/drug/label.json?limit=100
update_frequency: daily
next_scan_at: '2026-09-07T17:52:36.593610+00:00'
license:
  name: U.S. Food and Drug Administration website policy
  url: https://www.fda.gov/about-fda/about-website/website-policies
tags:
- api.fda.gov
geography:
- United States
revisions:
- revision_id: 20260907135233-9f179e3cc9ea
  detected_at: '2026-09-07T13:52:33+00:00'
  source_updated_at: null
  context: label.json detected from label.json.
  assets:
  - asset_id: asset-e52d5137baba82d7
    name: label.json
    source_url: https://api.fda.gov/drug/label.json?limit=100
    media_type: application/json; charset=utf-8
    content_hash: e52d5137baba82d74a5040a7319493e0415bc33d43dacb7cc37cf6c64c12672f
    size_bytes: 3951158
    parent_archive_id: null
  row_count: 100
  headers:
  - abuse
  - active_ingredient
  - active_ingredient_table
  - adverse_reactions
  - adverse_reactions_table
  - animal_pharmacology_and_or_toxicology
  - ask_doctor
  - ask_doctor_or_pharmacist
  - boxed_warning
  - carcinogenesis_and_mutagenesis_and_impairment_of_fertility
  - clinical_pharmacology
  - clinical_pharmacology_table
  - clinical_studies
  - clinical_studies_table
  - contraindications
  - controlled_substance
  - dependence
  - description
  - description_table
  - do_not_use
  - dosage_and_administration
  - dosage_and_administration_table
  - dosage_forms_and_strengths
  - dosage_forms_and_strengths_table
  - drug_abuse_and_dependence
  - drug_abuse_and_dependence_table
  - drug_and_or_laboratory_test_interactions
  - drug_interactions
  - drug_interactions_table
  - effective_time
  - general_precautions
  - geriatric_use
  - geriatric_use_table
  - how_supplied
  - how_supplied_table
  - id
  - inactive_ingredient
  - indications_and_usage
  - information_for_patients
  - instructions_for_use
  - instructions_for_use_table
  - keep_out_of_reach_of_children
  - labor_and_delivery
  - laboratory_tests
  - mechanism_of_action
  - microbiology
  - microbiology_table
  - nonclinical_toxicology
  - nonteratogenic_effects
  - nursing_mothers
  - openfda
  - other_safety_information
  - overdosage
  - package_label_principal_display_panel
  - patient_medication_information
  - pediatric_use
  - pediatric_use_table
  - pharmacodynamics
  - pharmacodynamics_table
  - pharmacogenomics
  - pharmacokinetics
  - pharmacokinetics_table
  - precautions
  - precautions_table
  - pregnancy
  - pregnancy_or_breast_feeding
  - pregnancy_table
  - purpose
  - purpose_table
  - questions
  - recent_major_changes
  - recent_major_changes_table
  - references
  - references_table
  - set_id
  - spl_medguide
  - spl_medguide_table
  - spl_patient_package_insert
  - spl_patient_package_insert_table
  - spl_product_data_elements
  - spl_unclassified_section
  - spl_unclassified_section_table
  - stop_use
  - storage_and_handling
  - teratogenic_effects
  - use_in_specific_populations
  - use_in_specific_populations_table
  - user_safety_warnings
  - version
  - warnings
  - warnings_and_cautions
  - warnings_table
  - when_using
  sample_rows:
  - effective_time: '20210902'
    inactive_ingredient:
    - INACTIVE INGREDIENTS Sucrose
    purpose:
    - 'USES USES: Temporary Relief - Acne, Boils* * Claims based on traditional homeopathic
      practice, not accepted medical evidence. Not FDA evaluated.'
    keep_out_of_reach_of_children:
    - Keep this and all medication out of reach of children
    warnings:
    - WARNINGS This product is to be used for self-limiting conditions If symptoms
      do not improve in 4 days, or worsen, discontinue use and seek assistance of
      health professional. As with any drug, if you are pregnant, or nursing a baby,
      seek professional advice before taking this product. Keep this and all medication
      out of reach of children Do not use if capseal is broken or missing. Close the
      cap tightly after use.
    questions:
    - QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | [email protected] Rxhomeo,
      Inc 3200 Commander Dr, Ste 100-W1, Carrollton, TX 75006 USA
    spl_product_data_elements:
    - SILICEA SILICEA SUCROSE SILICON DIOXIDE SILICON DIOXIDE
    openfda:
      brand_name:
      - SILICEA
      generic_name:
      - SILICEA
      manufacturer_name:
      - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
      product_ndc:
      - 15631-0404
      product_type:
      - HUMAN OTC DRUG
      route:
      - ORAL
      substance_name:
      - SILICON DIOXIDE
      spl_id:
      - ca7bbcc8-2354-375c-e053-2995a90a72a0
      spl_set_id:
      - 0000025c-6dbf-4af7-a741-5cbacaed519a
      package_ndc:
      - 15631-0404-0
      - 15631-0404-1
      - 15631-0404-2
      - 15631-0404-3
      - 15631-0404-4
      - 15631-0404-5
      - 15631-0404-6
      - 15631-0404-7
      is_original_packager:
      - true
      upc:
      - '8907460005526'
      unii:
      - ETJ7Z6XBU4
    version: '2'
    dosage_and_administration:
    - DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested
      by physician. Children 2 years and older- take 1/2 the adult dose.
    pregnancy_or_breast_feeding:
    - As with any drug, if you are pregnant, or nursing a baby, seek professional
      advice before taking this product.
    stop_use:
    - If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance
      of health professional.
    storage_and_handling:
    - STORAGE Store in a cool dark place
    do_not_use:
    - Do not use if capseal is broken or missing. Close the cap tightly after use.
    package_label_principal_display_panel:
    - Mini-Label Label-Pellets Blister-Pack Carton-Pack
    indications_and_usage:
    - INDICATIONS Condition listed above or as directed by the physician
    set_id: 0000025c-6dbf-4af7-a741-5cbacaed519a
    id: ca7bbcc8-2354-375c-e053-2995a90a72a0
    active_ingredient:
    - ACTIVE INGREDIENT SILICEA HPUS 2X and higher
  - effective_time: '20150109'
    inactive_ingredient:
    - 'INGREDIENTS: TALC, POLYMETHYL METHACRYLATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE
      CROSSPOLYMER, CALCIUM SILICATE, TRIETHYLHEXANOIN, ALUMINUM HYDROXIDE, LAUROYL
      LYSINE, METHICONE, PHENOXYETHANOL, DIMETHICONE, ALUMINUM DIMYRISTATE, HYDROXYAPATITIE
      [+/-: MICA (CI77019), IRON OXIDES (CI 77491/CI 77492/CI 77499)]'
    purpose:
    - Purpose Sunscreen
    keep_out_of_reach_of_children:
    - Keep out of reach of children If product is swallowed, get medical help or contact
      a Poison Control Center right away
    warnings:
    - Warnings For external use only.
    when_using:
    - When using this product keep out of eyes. Rinse with water to remove.
    spl_product_data_elements:
    - CHANTECAILLE PROTECTION NATURELLE BRONZE SPF 46 TITANIUM DIOXIDE, OCTINOXATE,
      ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE OCTINOXATE OCTINOXATE ZINC OXIDE
      ZINC OXIDE TALC CALCIUM SILICATE TRIETHYLHEXANOIN ALUMINUM HYDROXIDE LAUROYL
      LYSINE PHENOXYETHANOL DIMETHICONE ALUMINUM DIMYRISTATE MICA FERRIC OXIDE RED
    openfda: {}
    version: '4'
    dosage_and_administration:
    - Directions Protection Naturelle SPF 46 PA+++ Powder can be used on clean skin
      or over makeup. Shake lightly to activate the flow of powder. Sweep the brush
      all over the face to evenly distribute powder for immediate UVA/UVB protection.
    package_label_principal_display_panel:
    - CHANTECAILLE Protection Naturelle SPF 46 PA+++ Powder NET WT. 0.088 OZ. 2.5g
      e
    - CHANTECAILLE PROTECTION NATURELLE BRONZE SPF 46 .088OZ/2.5g (42893-030-00) CHANTECAILLE
      PROTECTION NATURELLE SPF 46
    indications_and_usage:
    - Uses Multi-purpose mineral powder provides broad-spectrum SPF 46 PA+++ protection.
      Leaves the skin flawless and protected.
    set_id: 0000076a-fc39-4208-ace8-6c2cb367904f
    id: f229e866-5775-4e42-a316-8480dd92fec6
    active_ingredient:
    - 'BRONZE ACTIVE INGREDIENTS: TITANIUM DIOXIDE 2 %, ETHYLHEXYL METHOXYCINNAMATE
      7%, ZINC OXIDE 24.5%'
  - spl_product_data_elements:
    - Betadine POVIDONE-IODINE POVIDONE-IODINE IODINE C12-15 Pareth-9 Water Sodium
      Hydroxide Bottle Label
    active_ingredient:
    - Drug Facts Active ingredients Povidone-iodine, 5% (0.5% available iodine)
    purpose:
    - Purpose First aid Antiseptic
    indications_and_usage:
    - Uses First aid to help prevent infection in minor cuts scrapes burns
    warnings:
    - Warnings For external use only
    do_not_use:
    - Do not use in the eyes over large areas of the body If you are allergic to povidone-iodine
      or any other ingredients in this preparation
    ask_doctor:
    - Ask a doctor before use if you have deep or puncture wounds serious burns animal
      bites
    stop_use:
    - Stop use and ask a doctor if the condition persists or gets worse you need to
      use this product for more than 1 week
    keep_out_of_reach_of_children:
    - Keep out of reach of children If swallowed, get medical help or contact a Poison
      Control Center right away.
    dosage_and_administration:
    - Directions clean the affected area spray a small amount of the product on the
      area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let
      dry first
    storage_and_handling:
    - "Other information store at 25\u2070C (77\u2070F); excursions permitted between\
      \ 15\u2070-30\u2070C (59\u2070-86\u2070F) Do Not Freeze"
    inactive_ingredient:
    - Inactive ingredients pareth 25-9, purified water, sodium hydroxide Questions?
      1-833-288-2684
    package_label_principal_display_panel:
    - "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NEW LOOK! HOSPITAL TRUSTED SINCE 1955\
      \ BETADINE \xAE ANTISEPTIC 5% POVIDONE-IODINE First Aid Antiseptic Spray \u221A\
      \ Ideal for Minor Cuts, Wounds, Scrapes & Burns \u221A Kills 99.9% of Germs\
      \ * To Prevent Infection \u221A Works in Seconds t \u221A No Stinging or Burning\
      \ 3 fl oz (88.7mL) Helps protect against skin infection Golden brown color indicates\
      \ area treated Visit www.Betadine.com for more information * commonlly associated\
      \ with skin infections. t based on in vitro lab data. Dist. by: Atlantis Consumer\
      \ Healthcare Inc. Bridgewater, NJ 08807 USA \xA92024 Atlantis Consumer Healthcare\
      \ Inc. Betadine is a registered trademark of Atlantis Consumer Healthcare Inc.\
      \ A0324"
    set_id: 00002127-02bc-4c66-b0c3-ca29d8224afc
    id: b8f5797b-73e1-4201-b824-2cdd50c90497
    effective_time: '20250102'
    version: '1'
    openfda:
      application_number:
      - M003
      brand_name:
      - Betadine
      generic_name:
      - POVIDONE-IODINE
      manufacturer_name:
      - Atlantis Consumer Healthcare, Inc.
      product_ndc:
      - 67618-192
      product_type:
      - HUMAN OTC DRUG
      route:
      - TOPICAL
      substance_name:
      - POVIDONE-IODINE
      rxcui:
      - '108204'
      - '238850'
      spl_id:
      - b8f5797b-73e1-4201-b824-2cdd50c90497
      spl_set_id:
      - 00002127-02bc-4c66-b0c3-ca29d8224afc
      package_ndc:
      - 67618-192-03
      is_original_packager:
      - true
      upc:
      - 0367618160039
      nui:
      - N0000175486
      - M0011640
      pharm_class_epc:
      - Antiseptic [EPC]
      pharm_class_cs:
      - Iodine [CS]
      unii:
      - 85H0HZU99M
  - spl_product_data_elements:
    - Mezereum DAPHNE MEZEREUM BARK SUCROSE LACTOSE DAPHNE MEZEREUM BARK DAPHNE MEZEREUM
      BARK white
    active_ingredient:
    - ACTIVE INGREDIENTS MEZEREUM
    purpose:
    - USES To relieve the symptoms of itching.
    keep_out_of_reach_of_children:
    - KEEP OUT OF REACH OF CHILDREN Keep this and all medicines out of reach of children.
    indications_and_usage:
    - 'INDICATIONS Indications: MEZEREUM Itching'
    warnings:
    - STOP USE AND ASK DOCTOR If symptoms persist/worsen or if pregnant/nursing, stop
      use and consult your practitioner.
    dosage_and_administration:
    - 'DIRECTIONS Adults: Dissolve 3 to 5 under the tongue three times a day or as
      directed by Lic. Practitioner. Take at greater intervals as condition subsides.
      Children: Dissolve 3 to 5 under the tongue three times a day or as directed
      by Lic. Practitioner. Take at greater intervals as condition subsides.'
    inactive_ingredient:
    - INACTIVE INGREDIENTS Sucrose/Lactose
    package_label_principal_display_panel:
    - "PRINCIPAL DISPLAY PANEL The OTC potency range of MEZEREUM is 2x\u201330x, 1c\u2013\
      30c, 200c, 1m, 10m, 50m, and CM. Availability is subject to change. All WHP\
      \ single remedies are made to order; thus, the labels are printed on the same\
      \ label stock as the orders are filled. \u2018Bottle Size\u2019 and \u2018Potency\u2019\
      \ vary on the label depending on customer choice. Standard bottle sizes for\
      \ pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce. Label"
    set_id: 00006ebc-ec2b-406c-96b7-a3cc422e933f
    id: 01f4b0f6-94df-fd91-e063-6394a90a7997
    effective_time: '20230802'
    version: '3'
    openfda: {}
  - spl_product_data_elements:
    - Ofloxacin Ofloxacin OFLOXACIN OFLOXACIN Sodium Chloride Hydrochloric Acid Sodium
      Hydroxide Water Benzalkonium Chloride
    spl_unclassified_section:
    - Rx only
    - 'CONJUNCTIVITIS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus
      aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae
      Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa'
    - 'CORNEAL ULCERS: *Efficacy for this organism was studied in fewer than 10 infections
      Gram-positive bacteria: Gram-negative bacteria: Anaerobic species: Staphylococcus
      aureus Pseudomonas aeruginosa Propionibacterium acnes Staphylococcus epidermidis
      Serratia marcescens* Streptococcus pneumoniae'
    description:
    - "DESCRIPTION Ofloxacin Ophthalmic Solution USP, 0.3% is a sterile ophthalmic\
      \ solution. It is a fluorinated carboxyquinolone anti-infective for topical\
      \ ophthalmic use. Chemical Name: (\xB1)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7\
      \ H -pyrido [1,2,3- de ]-1,4-benzoxazine-6-carboxylic acid. Contains: Active:\
      \ ofloxacin 0.3% (3 mg/mL); Preservative: benzalkonium chloride (0.005%); Inactives:\
      \ sodium chloride and water for injection. May also contain hydrochloric acid\
      \ and/or sodium hydroxide to adjust pH. Ofloxacin Ophthalmic Solution USP, 0.3%\
      \ is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has\
      \ an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which\
      \ differs from other fluorinated 4-quinolones in that there is a six member\
      \ (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.\
      \ Figure"
    clinical_pharmacology:
    - 'CLINICAL PHARMACOLOGY Pharmacokinetics: Serum, urine and tear concentrations
      of ofloxacin were measured in 30 healthy women at various time points during
      a ten-day course of treatment with ofloxacin ophthalmic solution. The mean serum
      ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin
      concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after
      QID dosing for 10 1/2 days. Maximum serum ofloxacin concentrations after ten
      days of topical ophthalmic dosing were more than 1000 times lower than those
      reported after standard oral doses of ofloxacin. Tear ofloxacin concentrations
      ranged from 5.7 to 31 mcg/g during the 40 minute period following the last dose
      on day 11. Mean tear concentration measured four hours after topical ophthalmic
      dosing was 9.2 mcg/g. Corneal tissue concentrations of 4.4 mcg/mL were observed
      four hours after beginning topical ocular application of two drops of ofloxacin
      ophthalmic solution every 30 minutes. Ofloxacin was excreted in the urine primarily
      unmodified. Microbiology: Ofloxacin has in vitro activity against a broad range
      of gram-positive and gram-negative aerobic and anaerobic bacteria. Ofloxacin
      is bactericidal at concentrations equal to or slightly greater than inhibitory
      concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible
      bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which
      is a critical catalyst in the duplication, transcription, and repair of bacterial
      DNA. Cross-resistance has been observed between ofloxacin and other fluoroquinolones.
      There is generally no cross-resistance between ofloxacin and other classes of
      antibacterial agents such as beta-lactams or aminoglycosides. Ofloxacin has
      been shown to be active against most strains of the following organisms both
      in vitro and clinically, in conjunctival and/or corneal ulcer infections (see
      INDICATIONS AND USAGE ). *Efficacy for this organism was studied in fewer than
      10 infections AEROBES, GRAM-POSITIVE: AEROBES, GRAM-NEGATIVE: ANAEROBIC SPECIES:
      Staphylococcus aureus Enterobacter cloacae Propionibacterium acnes Staphylococcus
      epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis
      Pseudomonas aeruginosa Serratia marcescens* The safety and effectiveness of
      ofloxacin ophthalmic solution in treating ophthalmologic infections due to the
      following organisms have not been established in adequate and well-controlled
      clinical trials. Ofloxacin ophthalmic solution has been shown to be active in
      vitro against most strains of these organisms but the clinical significance
      in ophthalmologic infections is unknown. AEROBES, GRAM-POSITIVE: AEROBES, GRAM-NEGATIVE:
      OTHER: Enterococcus faecalis Acinetobacter calcoaceticus var. anitratus Chlamydia
      trachomatis Listeria monocytogenes Acinetobacter calcoaceticus var. Iwoffii
      Staphylococcus capitis Citrobacter diversus Staphylococcus hominus Citrobacter
      freundii Staphylococcus simulans Enterobacter aerogenes Streptococcus pyogenes
      Enterobacter agglomerans Escherichia coli Haemophilus parainfluenzae Klebsiella
      oxytoca Klebsiella pneumoniae Moraxella (Branhamella) catarrhalis Moraxella
      lacunata Morganella morganii Neisseria gonorrhoeae Pseudomonas acidovorans Pseudomonas
      fluorescens Shigella sonnei Clinical Studies: Conjunctivitis: In a randomized,
      double-masked, multi-center clinical trial, ofloxacin ophthalmic solution was
      superior to its vehicle after 2 days of treatment in patients with conjunctivitis
      and positive conjunctival cultures. Clinical outcomes for the trial demonstrated
      a clinical improvement rate of 86% (54/63) for the ofloxacin treated group versus
      72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological
      outcomes for the same clinical trial demonstrated an eradication rate for causative
      pathogens of 65% (41/63) for the ofloxacin treated group versus 25% (17/67)
      for the vehicle treated group after 2 days of therapy. Please note that microbiologic
      eradication does not always correlate with clinical outcome in anti-infective
      trials. Corneal ulcers: In a randomized, double-masked, multi-center clinical
      trial of 140 subjects with positive cultures, ofloxacin ophthalmic solution
      treated subjects had an overall clinical success rate (complete re-epithelialization
      and no progression of the infiltrate for two consecutive visits) of 82% (61/74)
      compared to 80% (53/66) for the fortified antibiotic group, consisting of 1.5%
      tobramycin and 10% cefazolin solutions. The median time to clinical success
      was 11 days for the ofloxacin treated group and 10 days for the fortified treatment
      group.'
    clinical_pharmacology_table:
    - <table width="100%" styleCode="Noautorules"><col width="31.467%" align="left"/><col
      width="43.000%" align="left"/><col width="25.533%" align="left"/><tfoot><tr><td
      colspan="3" align="left" valign="top"><paragraph>*Efficacy for this organism
      was studied in fewer than 10 infections </paragraph></td></tr></tfoot><tbody><tr><td
      align="left" valign="top"><content styleCode="bold">AEROBES, GRAM-POSITIVE:</content></td><td
      align="left" valign="top"><content styleCode="bold">AEROBES, GRAM-NEGATIVE:</content></td><td
      align="left" valign="top"><content styleCode="bold">ANAEROBIC SPECIES:</content></td></tr><tr><td
      align="left" valign="top"><content styleCode="italics">Staphylococcus aureus</content></td><td
      align="left" valign="top"><content styleCode="italics">Enterobacter cloacae</content></td><td
      align="left" valign="top"><content styleCode="italics">Propionibacterium acnes</content></td></tr><tr><td
      align="left" valign="top"><content styleCode="italics">Staphylococcus epidermidis</content></td><td
      align="left" valign="top"><content styleCode="italics">Haemophilus influenzae</content></td><td
      align="left" valign="top"/></tr><tr><td align="left" valign="top"><content styleCode="italics">Streptococcus
      pneumoniae</content></td><td align="left" valign="top"><content styleCode="italics">Proteus
      mirabilis Pseudomonas aeruginosa</content></td><td align="left" valign="top"/></tr><tr><td
      align="left" valign="top"/><td align="left" valign="top"><content styleCode="italics">Serratia
      marcescens*</content></td><td align="left" valign="top"/></tr></tbody></table>
    - <table width="100%" styleCode="Noautorules"><col width="32.633%" align="left"/><col
      width="42.733%" align="left"/><col width="24.633%" align="left"/><tbody><tr><td
      align="left" valign="middle"><content styleCode="bold">AEROBES, GRAM-POSITIVE:</content></td><td
      align="left" valign="middle"><content styleCode="bold">AEROBES, GRAM-NEGATIVE:</content></td><td
      align="left" valign="middle"><content styleCode="bold">OTHER:</content></td></tr><tr><td
      align="left" valign="middle"><content styleCode="italics">Enterococcus faecalis</content></td><td
      align="left" valign="middle"><content styleCode="italics">Acinetobacter calcoaceticus
      var. anitratus</content></td><td align="left" valign="middle"><content styleCode="italics">Chlamydia
      trachomatis</content></td></tr><tr><td align="left" valign="middle"><content
      styleCode="italics">Listeria monocytogenes</content></td><td align="left" valign="middle"><content
      styleCode="italics">Acinetobacter calcoaceticus var. Iwoffii</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"><content
      styleCode="italics">Staphylococcus capitis</content></td><td align="left" valign="middle"><content
      styleCode="italics">Citrobacter diversus</content></td><td align="left" valign="bottom"/></tr><tr><td
      align="left" valign="middle"><content styleCode="italics">Staphylococcus hominus</content></td><td
      align="left" valign="middle"><content styleCode="italics">Citrobacter freundii</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"><content
      styleCode="italics">Staphylococcus simulans</content></td><td align="left" valign="middle"><content
      styleCode="italics">Enterobacter aerogenes</content></td><td align="left" valign="bottom"/></tr><tr><td
      align="left" valign="middle"><content styleCode="italics">Streptococcus pyogenes</content></td><td
      align="left" valign="middle"><content styleCode="italics">Enterobacter agglomerans</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="middle"><content styleCode="italics">Escherichia coli</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="middle"><content styleCode="italics">Haemophilus parainfluenzae</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="middle"><content styleCode="italics">Klebsiella oxytoca</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="middle"><content styleCode="italics">Klebsiella pneumoniae</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="bottom"><content styleCode="italics">Moraxella (Branhamella)
      catarrhalis</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Moraxella
      lacunata</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Morganella
      morganii</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Neisseria
      gonorrhoeae</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Pseudomonas
      acidovorans</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Pseudomonas
      fluorescens</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Shigella
      sonnei</content></td><td align="left" valign="bottom"/></tr></tbody></table>
    pharmacokinetics:
    - 'Pharmacokinetics: Serum, urine and tear concentrations of ofloxacin were measured
      in 30 healthy women at various time points during a ten-day course of treatment
      with ofloxacin ophthalmic solution. The mean serum ofloxacin concentration ranged
      from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from
      1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days.
      Maximum serum ofloxacin concentrations after ten days of topical ophthalmic
      dosing were more than 1000 times lower than those reported after standard oral
      doses of ofloxacin. Tear ofloxacin concentrations ranged from 5.7 to 31 mcg/g
      during the 40 minute period following the last dose on day 11. Mean tear concentration
      measured four hours after topical ophthalmic dosing was 9.2 mcg/g. Corneal tissue
      concentrations of 4.4 mcg/mL were observed four hours after beginning topical
      ocular application of two drops of ofloxacin ophthalmic solution every 30 minutes.
      Ofloxacin was excreted in the urine primarily unmodified.'
    microbiology:
    - 'Microbiology: Ofloxacin has in vitro activity against a broad range of gram-positive
      and gram-negative aerobic and anaerobic bacteria. Ofloxacin is bactericidal
      at concentrations equal to or slightly greater than inhibitory concentrations.
      Ofloxacin is thought to exert a bactericidal effect on susceptible bacterial
      cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical
      catalyst in the duplication, transcription, and repair of bacterial DNA. Cross-resistance
      has been observed between ofloxacin and other fluoroquinolones. There is generally
      no cross-resistance between ofloxacin and other classes of antibacterial agents
      such as beta-lactams or aminoglycosides. Ofloxacin has been shown to be active
      against most strains of the following organisms both in vitro and clinically,
      in conjunctival and/or corneal ulcer infections (see INDICATIONS AND USAGE ).
      *Efficacy for this organism was studied in fewer than 10 infections AEROBES,
      GRAM-POSITIVE: AEROBES, GRAM-NEGATIVE: ANAEROBIC SPECIES: Staphylococcus aureus
      Enterobacter cloacae Propionibacterium acnes Staphylococcus epidermidis Haemophilus
      influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa
      Serratia marcescens* The safety and effectiveness of ofloxacin ophthalmic solution
      in treating ophthalmologic infections due to the following organisms have not
      been established in adequate and well-controlled clinical trials. Ofloxacin
      ophthalmic solution has been shown to be active in vitro against most strains
      of these organisms but the clinical significance in ophthalmologic infections
      is unknown. AEROBES, GRAM-POSITIVE: AEROBES, GRAM-NEGATIVE: OTHER: Enterococcus
      faecalis Acinetobacter calcoaceticus var. anitratus Chlamydia trachomatis Listeria
      monocytogenes Acinetobacter calcoaceticus var. Iwoffii Staphylococcus capitis
      Citrobacter diversus Staphylococcus hominus Citrobacter freundii Staphylococcus
      simulans Enterobacter aerogenes Streptococcus pyogenes Enterobacter agglomerans
      Escherichia coli Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae
      Moraxella (Branhamella) catarrhalis Moraxella lacunata Morganella morganii Neisseria
      gonorrhoeae Pseudomonas acidovorans Pseudomonas fluorescens Shigella sonnei'
    microbiology_table:
    - <table width="100%" styleCode="Noautorules"><col width="31.467%" align="left"/><col
      width="43.000%" align="left"/><col width="25.533%" align="left"/><tfoot><tr><td
      colspan="3" align="left" valign="top"><paragraph>*Efficacy for this organism
      was studied in fewer than 10 infections </paragraph></td></tr></tfoot><tbody><tr><td
      align="left" valign="top"><content styleCode="bold">AEROBES, GRAM-POSITIVE:</content></td><td
      align="left" valign="top"><content styleCode="bold">AEROBES, GRAM-NEGATIVE:</content></td><td
      align="left" valign="top"><content styleCode="bold">ANAEROBIC SPECIES:</content></td></tr><tr><td
      align="left" valign="top"><content styleCode="italics">Staphylococcus aureus</content></td><td
      align="left" valign="top"><content styleCode="italics">Enterobacter cloacae</content></td><td
      align="left" valign="top"><content styleCode="italics">Propionibacterium acnes</content></td></tr><tr><td
      align="left" valign="top"><content styleCode="italics">Staphylococcus epidermidis</content></td><td
      align="left" valign="top"><content styleCode="italics">Haemophilus influenzae</content></td><td
      align="left" valign="top"/></tr><tr><td align="left" valign="top"><content styleCode="italics">Streptococcus
      pneumoniae</content></td><td align="left" valign="top"><content styleCode="italics">Proteus
      mirabilis Pseudomonas aeruginosa</content></td><td align="left" valign="top"/></tr><tr><td
      align="left" valign="top"/><td align="left" valign="top"><content styleCode="italics">Serratia
      marcescens*</content></td><td align="left" valign="top"/></tr></tbody></table>
    - <table width="100%" styleCode="Noautorules"><col width="32.633%" align="left"/><col
      width="42.733%" align="left"/><col width="24.633%" align="left"/><tbody><tr><td
      align="left" valign="middle"><content styleCode="bold">AEROBES, GRAM-POSITIVE:</content></td><td
      align="left" valign="middle"><content styleCode="bold">AEROBES, GRAM-NEGATIVE:</content></td><td
      align="left" valign="middle"><content styleCode="bold">OTHER:</content></td></tr><tr><td
      align="left" valign="middle"><content styleCode="italics">Enterococcus faecalis</content></td><td
      align="left" valign="middle"><content styleCode="italics">Acinetobacter calcoaceticus
      var. anitratus</content></td><td align="left" valign="middle"><content styleCode="italics">Chlamydia
      trachomatis</content></td></tr><tr><td align="left" valign="middle"><content
      styleCode="italics">Listeria monocytogenes</content></td><td align="left" valign="middle"><content
      styleCode="italics">Acinetobacter calcoaceticus var. Iwoffii</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"><content
      styleCode="italics">Staphylococcus capitis</content></td><td align="left" valign="middle"><content
      styleCode="italics">Citrobacter diversus</content></td><td align="left" valign="bottom"/></tr><tr><td
      align="left" valign="middle"><content styleCode="italics">Staphylococcus hominus</content></td><td
      align="left" valign="middle"><content styleCode="italics">Citrobacter freundii</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"><content
      styleCode="italics">Staphylococcus simulans</content></td><td align="left" valign="middle"><content
      styleCode="italics">Enterobacter aerogenes</content></td><td align="left" valign="bottom"/></tr><tr><td
      align="left" valign="middle"><content styleCode="italics">Streptococcus pyogenes</content></td><td
      align="left" valign="middle"><content styleCode="italics">Enterobacter agglomerans</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="middle"><content styleCode="italics">Escherichia coli</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="middle"><content styleCode="italics">Haemophilus parainfluenzae</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="middle"><content styleCode="italics">Klebsiella oxytoca</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="middle"><content styleCode="italics">Klebsiella pneumoniae</content></td><td
      align="left" valign="bottom"/></tr><tr><td align="left" valign="middle"/><td
      align="left" valign="bottom"><content styleCode="italics">Moraxella (Branhamella)
      catarrhalis</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Moraxella
      lacunata</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Morganella
      morganii</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Neisseria
      gonorrhoeae</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Pseudomonas
      acidovorans</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Pseudomonas
      fluorescens</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="bottom"><content styleCode="italics">Shigella
      sonnei</content></td><td align="left" valign="bottom"/></tr></tbody></table>
    clinical_studies:
    - 'Clinical Studies: Conjunctivitis: In a randomized, double-masked, multi-center
      clinical trial, ofloxacin ophthalmic solution was superior to its vehicle after
      2 days of treatment in patients with conjunctivitis and positive conjunctival
      cultures. Clinical outcomes for the trial demonstrated a clinical improvement
      rate of 86% (54/63) for the ofloxacin treated group versus 72% (48/67) for the
      placebo treated group after 2 days of therapy. Microbiological outcomes for
      the same clinical trial demonstrated an eradication rate for causative pathogens
      of 65% (41/63) for the ofloxacin treated group versus 25% (17/67) for the vehicle
      treated group after 2 days of therapy. Please note that microbiologic eradication
      does not always correlate with clinical outcome in anti-infective trials. Corneal
      ulcers: In a randomized, double-masked, multi-center clinical trial of 140 subjects
      with positive cultures, ofloxacin ophthalmic solution treated subjects had an
      overall clinical success rate (complete re-epithelialization and no progression
      of the infiltrate for two consecutive visits) of 82% (61/74) compared to 80%
      (53/66) for the fortified antibiotic group, consisting of 1.5% tobramycin and
      10% cefazolin solutions. The median time to clinical success was 11 days for
      the ofloxacin treated group and 10 days for the fortified treatment group.'
    indications_and_usage:
    - 'INDICATIONS AND USAGE Ofloxacin ophthalmic solution is indicated for the treatment
      of infections caused by susceptible strains of the following bacteria in the
      conditions listed below:'
    spl_unclassified_section_table:
    - <table width="100%" styleCode="Noautorules"><col width="28.850%" align="left"/><col
      width="71.150%" align="left"/><tbody><tr><td align="left" valign="middle"><content
      styleCode="bold">Gram-positive bacteria:</content></td><td align="left" valign="middle"><content
      styleCode="bold">Gram-negative bacteria:</content></td></tr><tr><td align="left"
      valign="middle"><content styleCode="italics">Staphylococcus aureus</content></td><td
      align="left" valign="middle"><content styleCode="italics">Enterobacter cloacae</content></td></tr><tr><td
      align="left" valign="middle"><content styleCode="italics">Staphylococcus epidermidis</content></td><td
      align="left" valign="middle"><content styleCode="italics">Haemophilus influenzae</content></td></tr><tr><td
      align="left" valign="middle"><content styleCode="italics">Streptococcus pneumoniae</content></td><td
      align="left" valign="middle"><content styleCode="italics">Proteus mirabilis</content></td></tr><tr><td
      align="left" valign="middle"/><td align="left" valign="middle"><content styleCode="italics">Pseudomonas
      aeruginosa</content></td></tr></tbody></table>
    - <table width="100%" styleCode="Noautorules"><col width="34.767%" align="left"/><col
      width="34.033%" align="left"/><col width="31.200%" align="left"/><tfoot><tr><td
      colspan="3" align="left" valign="top"><paragraph>*Efficacy for this organism
      was studied in fewer than 10 infections </paragraph></td></tr></tfoot><tbody><tr><td
      align="justify" valign="middle"><content styleCode="bold">Gram-positive bacteria:</content></td><td
      align="justify" valign="middle"><content styleCode="bold">Gram-negative bacteria:</content></td><td
      align="justify" valign="middle"><content styleCode="bold">Anaerobic species:</content></td></tr><tr><td
      align="justify" valign="middle"><content styleCode="italics">Staphylococcus
      aureus</content></td><td align="justify" valign="middle"><content styleCode="italics">Pseudomonas
      aeruginosa</content></td><td align="justify" valign="middle"><content styleCode="italics">Propionibacterium
      acnes</content></td></tr><tr><td align="left" valign="middle"><content styleCode="italics">Staphylococcus
      epidermidis</content></td><td align="left" valign="middle"><content styleCode="italics">Serratia
      marcescens*</content></td><td align="left" valign="bottom"/></tr><tr><td align="left"
      valign="middle"/><td align="left" valign="middle"><content styleCode="italics">Streptococcus
      pneumoniae</content></td><td align="left" valign="bottom"/></tr></tbody></table>
    contraindications:
    - CONTRAINDICATIONS Ofloxacin ophthalmic solution is contraindicated in patients
      with a history of hypersensitivity to ofloxacin, to other quinolones, or to
      any of the components in this medication (see WARNINGS ).
    warnings:
    - WARNINGS NOT FOR INJECTION. Ofloxacin ophthalmic solution should not be injected
      subconjunctivally, nor should it be introduced directly into the anterior chamber
      of the eye. There are rare reports of anaphylactic reaction/shock and fatal
      hypersensitivity reactions in patients receiving systemic quinolones, some following
      the first dose, including ofloxacin. Some reactions were accompanied by cardiovascular
      collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal
      or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare
      occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal
      necrolysis, has been reported in a patient who was receiving topical ophthalmic
      ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug.
      Serious acute hypersensitivity reactions may require immediate emergency treatment.
      Oxygen and airway management, including intubation should be administered as
      clinically indicated.
    precautions:
    - 'PRECAUTIONS General: As with other anti-infectives, prolonged use may result
      in overgrowth of nonsusceptible organisms, including fungi. If superinfection
      occurs discontinue use and institute alternative therapy. Whenever clinical
      judgment dictates, the patient should be examined with the aid of magnification,
      such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
      Ofloxacin should be discontinued at the first appearance of a skin rash or any
      other sign of hypersensitivity reaction. The systemic administration of quinolones,
      including ofloxacin, has led to lesions or erosions of the cartilage in weight-bearing
      joints and other signs of arthropathy in immature animals of various species.
      Ofloxacin, administered systemically at 10 mg/kg/day in young dogs (equivalent
      to 110 times the maximum recommended daily adult ophthalmic dose) has been associated
      with these types of effects. Information for Patients: Avoid contaminating the
      applicator tip with material from the eye, fingers or other source. Systemic
      quinolones, including ofloxacin, have been associated with hypersensitivity
      reactions, even following a single dose. Discontinue use immediately and contact
      your physician at the first sign of a rash or allergic reaction. Drug Interactions:
      Specific drug interaction studies have not been conducted with ofloxacin ophthalmic
      solution. However, the systemic administration of some quinolones has been shown
      to elevate plasma concentrations of theophylline, interfere with the metabolism
      of caffeine, and enhance the effects of the oral anticoagulant warfarin and
      its derivatives, and has been associated with transient elevations in serum
      creatinine in patients receiving cyclosporine concomitantly. Carcinogenesis,
      Mutagenesis, Impairment of Fertility: Long term studies to determine the carcinogenic
      potential of ofloxacin have not been conducted. Ofloxacin was not mutagenic
      in the Ames test, in vitro and in vivo cytogenic assay, sister chromatid exchange
      assay (Chinese hamster and human cell lines), unscheduled DNA synthesis (UDS)
      assay using human fibroblasts, the dominant lethal assay, or mouse micronucleus
      assay. Ofloxacin was positive in the UDS test using rat hepatocyte, and in the
      mouse lymphoma assay. In fertility studies in rats, ofloxacin did not affect
      male or female fertility or morphological or reproductive performance at oral
      dosing up to 360 mg/kg/day (equivalent to 4000 times the maximum recommended
      daily ophthalmic dose). Pregnancy: Teratogenic Effects: Ofloxacin has been shown
      to have an embryocidal effect in rats and in rabbits when given in doses of
      810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic
      dose) and 160 mg/kg/day (equivalent to 1800 times the maximum recommended daily
      ophthalmic dose). These dosages resulted in decreased fetal body weight and
      increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal
      variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin
      has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160
      mg/kg/day when administered to pregnant rats and rabbits, respectively. Nonteratogenic
      Effects: Additional studies in rats with doses up to 360 mg/kg/day during late
      gestation showed no adverse effect on late fetal development, labor, delivery,
      lactation, neonatal viability, or growth of the newborn. There are, however,
      no adequate and well-controlled studies in pregnant women. Ofloxacin ophthalmic
      solution should be used during pregnancy only if the potential benefit justifies
      the potential risk to the fetus. Nursing Mothers: In nursing women a single
      200 mg oral dose resulted in concentrations of ofloxacin in milk which were
      similar to those found in plasma. It is not known whether ofloxacin is excreted
      in human milk following topical ophthalmic administration. Because of the potential
      for serious adverse reactions from ofloxacin in nursing infants, a decision
      should be made whether to discontinue nursing or to discontinue the drug, taking
      into account the importance of the drug to the mother. Pediatric use: Safety
      and effectiveness in infants below the age of one year have not been established.
      Quinolones, including ofloxacin, have been shown to cause arthropathy in immature
      animals after oral administration; however, topical ocular administration of
      ofloxacin to immature animals has not shown any arthropathy. There is no evidence
      that the ophthalmic dosage form of ofloxacin has any effect on weight bearing
      joints. Geriatric use: No overall differences in safety or effectiveness have
      been observed between elderly and younger patients.'
    general_precautions:
    - 'General: As with other anti-infectives, prolonged use may result in overgrowth
      of nonsusceptible organisms, including fungi. If superinfection occurs discontinue
      use and institute alternative therapy. Whenever clinical judgment dictates,
      the patient should be examined with the aid of magnification, such as slit lamp
      biomicroscopy and, where appropriate, fluorescein staining. Ofloxacin should
      be discontinued at the first appearance of a skin rash or any other sign of
      hypersensitivity reaction. The systemic administration of quinolones, including
      ofloxacin, has led to lesions or erosions of the cartilage in weight-bearing
      joints and other signs of arthropathy in immature animals of various species.
      Ofloxacin, administered systemically at 10 mg/kg/day in young dogs (equivalent
      to 110 times the maximum recommended daily adult ophthalmic dose) has been associated
      with these types of effects.'
    information_for_patients:
    - 'Information for Patients: Avoid contaminating the applicator tip with material
      from the eye, fingers or other source. Systemic quinolones, including ofloxacin,
      have been associated with hypersensitivity reactions, even following a single
      dose. Discontinue use immediately and contact your physician at the first sign
      of a rash or allergic reaction.'
    drug_interactions:
    - 'Drug Interactions: Specific drug interaction studies have not been conducted
      with ofloxacin ophthalmic solution. However, the systemic administration of
      some quinolones has been shown to elevate plasma concentrations of theophylline,
      interfere with the metabolism of caffeine, and enhance the effects of the oral
      anticoagulant warfarin and its derivatives, and has been associated with transient
      elevations in serum creatinine in patients receiving cyclosporine concomitantly.'
    carcinogenesis_and_mutagenesis_and_impairment_of_fertility:
    - 'Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies to
      determine the carcinogenic potential of ofloxacin have not been conducted. Ofloxacin
      was not mutagenic in the Ames test, in vitro and in vivo cytogenic assay, sister
      chromatid exchange assay (Chinese hamster and human cell lines), unscheduled
      DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay,
      or mouse micronucleus assay. Ofloxacin was positive in the UDS test using rat
      hepatocyte, and in the mouse lymphoma assay. In fertility studies in rats, ofloxacin
      did not affect male or female fertility or morphological or reproductive performance
      at oral dosing up to 360 mg/kg/day (equivalent to 4000 times the maximum recommended
      daily ophthalmic dose).'
    pregnancy:
    - 'Pregnancy: Teratogenic Effects: Ofloxacin has been shown to have an embryocidal
      effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent
      to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day
      (equivalent to 1800 times the maximum recommended daily ophthalmic dose). These
      dosages resulted in decreased fetal body weight and increased fetal mortality
      in rats and rabbits, respectively. Minor fetal skeletal variations were reported
      in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be
      teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered
      to pregnant rats and rabbits, respectively. Nonteratogenic Effects: Additional
      studies in rats with doses up to 360 mg/kg/day during late gestation showed
      no adverse effect on late fetal development, labor, delivery, lactation, neonatal
      viability, or growth of the newborn. There are, however, no adequate and well-controlled
      studies in pregnant women. Ofloxacin ophthalmic solution should be used during
      pregnancy only if the potential benefit justifies the potential risk to the
      fetus.'
    nonteratogenic_effects:
    - 'Nonteratogenic Effects: Additional studies in rats with doses up to 360 mg/kg/day
      during late gestation showed no adverse effect on late fetal development, labor,
      delivery, lactation, neonatal viability, or growth of the newborn. There are,
      however, no adequate and well-controlled studies in pregnant women. Ofloxacin
      ophthalmic solution should be used during pregnancy only if the potential benefit
      justifies the potential risk to the fetus.'
    nursing_mothers:
    - 'Nursing Mothers: In nursing women a single 200 mg oral dose resulted in concentrations
      of ofloxacin in milk which were similar to those found in plasma. It is not
      known whether ofloxacin is excreted in human milk following topical ophthalmic
      administration. Because of the potential for serious adverse reactions from
      ofloxacin in nursing infants, a decision should be made whether to discontinue
      nursing or to discontinue the drug, taking into account the importance of the
      drug to the mother.'
    pediatric_use:
    - 'Pediatric use: Safety and effectiveness in infants below the age of one year
      have not been established. Quinolones, including ofloxacin, have been shown
      to cause arthropathy in immature animals after oral administration; however,
      topical ocular administration of ofloxacin to immature animals has not shown
      any arthropathy. There is no evidence that the ophthalmic dosage form of ofloxacin
      has any effect on weight bearing joints.'
    geriatric_use:
    - 'Geriatric use: No overall differences in safety or effectiveness have been
      observed between elderly and younger patients.'
    adverse_reactions:
    - 'ADVERSE REACTIONS Ophthalmic use: The most frequently reported drug-related
      adverse reaction was transient ocular burning or discomfort. Other reported
      reactions include stinging, redness, itching, chemical conjunctivitis/keratitis,
      ocular/periocular/facial edema, foreign body sensation, photophobia, blurred
      vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea
      have been received. Refer to WARNINGS for additional adverse reactions.'
    dosage_and_administration:
    - 'DOSAGE AND ADMINISTRATION The recommended dosage regimen for the treatment
      of bacterial conjunctivitis is: Days 1 and 2 Instill one to two drops every
      two to four hours in the affected eye(s). Days 3 through 7 Instill one to two
      drops four times daily. The recommended dosage regimen for the treatment of
      bacterial corneal ulcer is: Days 1 and 2 Instill one to two drops into the affected
      eye every 30 minutes, while awake. Awaken at approximately four and six hours
      after retiring and instill one to two drops. Days 3 through 7 to 9 Instill one
      to two drops hourly, while awake. Days 7 to 9 through treatment completion Instill
      one to two drops, four times daily.'
    dosage_and_administration_table:
    - '<table width="100%" styleCode="Noautorules"><col width="33.600%" align="left"/><col
      width="66.400%" align="left"/><tbody><tr><td align="left" valign="top">Days
      1 and 2 </td><td align="left" valign="top">Instill one to two drops every two
      to four hours in the affected eye(s). </td></tr><tr><td align="left" valign="top">Days
      3 through 7 </td><td align="left" valign="top">Instill one to two drops four
      times daily. </td></tr><tr><td colspan="2" align="justify" valign="top">The
      recommended dosage regimen for the treatment of <content styleCode="bold">bacterial
      corneal ulcer</content> is: </td></tr><tr><td align="left" valign="top">Days
      1 and 2 </td><td align="left" valign="top">Instill one to two drops into the
      affected eye every 30 minutes, while awake. </td></tr><tr><td colspan="2" align="left"
      valign="top">Awaken at approximately four and six hours after retiring and instill
      one to two drops. </td></tr><tr><td align="left" valign="top">Days 3 through
      7 to 9 </td><td align="left" valign="top">Instill one to two drops hourly, while
      awake. </td></tr><tr><td align="left" valign="top">Days 7 to 9 through treatment
      completion </td><td align="left" valign="top">Instill one to two drops, four
      times daily. </td></tr></tbody></table>'
    how_supplied:
    - 'HOW SUPPLIED Product: 53002-1324 NDC: 53002-1324-1 5 mL in a BOTTLE, DROPPER
      NDC: 53002-1324-2 10 mL in a BOTTLE, DROPPER'
    package_label_principal_display_panel:
    - Ofloxacin 0.3% Ophthalmic Solution Label Image
    set_id: 00011703-bc55-4c0c-858c-149dc674bc3c
    id: f8ce57b8-ebf7-4dc1-96ec-c8fbc41c17ff
    effective_time: '20230905'
    version: '7'
    openfda: {}
  parser_errors:
  - 'Partial response: 100 of 262663 provider records'
  logical_asset_id: null
related_dataset_ids: []
quality:
  score: 80
  parsing_errors:
  - 'Partial response: 100 of 262663 provider records'
  stale_warning: null
  broken_source_report: null
rss_feed_url: null
odc_version: '0.1'
last_successful_scan_at: null

Current dbt Source YAML

Open raw YAML

version: 2
sources:
- name: fda_drug_labels
  description: FDA Drug Labels Sample discovered from api.fda.gov. Bounded source
    query (limit=100); completeness is not assumed.
  meta:
    opendataodc:
      dataset_id: fda-drug-labels
      revision_id: 20260907135233-9f179e3cc9ea
      detected_at: '2026-09-07T13:52:33+00:00'
      source_url: https://api.fda.gov/drug/label.json?limit=100
  tables:
  - name: label_json
    description: Source asset label.json.
    meta:
      opendataodc:
        source_url: https://api.fda.gov/drug/label.json?limit=100
        content_hash: e52d5137baba82d74a5040a7319493e0415bc33d43dacb7cc37cf6c64c12672f
        row_count: 100
        parser_errors:
        - 'Partial response: 100 of 262663 provider records'
    columns:
    - name: abuse
    - name: active_ingredient
    - name: active_ingredient_table
    - name: adverse_reactions
    - name: adverse_reactions_table
    - name: animal_pharmacology_and_or_toxicology
    - name: ask_doctor
    - name: ask_doctor_or_pharmacist
    - name: boxed_warning
    - name: carcinogenesis_and_mutagenesis_and_impairment_of_fertility
    - name: clinical_pharmacology
    - name: clinical_pharmacology_table
    - name: clinical_studies
    - name: clinical_studies_table
    - name: contraindications
    - name: controlled_substance
    - name: dependence
    - name: description
    - name: description_table
    - name: do_not_use
    - name: dosage_and_administration
    - name: dosage_and_administration_table
    - name: dosage_forms_and_strengths
    - name: dosage_forms_and_strengths_table
    - name: drug_abuse_and_dependence
    - name: drug_abuse_and_dependence_table
    - name: drug_and_or_laboratory_test_interactions
    - name: drug_interactions
    - name: drug_interactions_table
    - name: effective_time
    - name: general_precautions
    - name: geriatric_use
    - name: geriatric_use_table
    - name: how_supplied
    - name: how_supplied_table
    - name: id
    - name: inactive_ingredient
    - name: indications_and_usage
    - name: information_for_patients
    - name: instructions_for_use
    - name: instructions_for_use_table
    - name: keep_out_of_reach_of_children
    - name: labor_and_delivery
    - name: laboratory_tests
    - name: mechanism_of_action
    - name: microbiology
    - name: microbiology_table
    - name: nonclinical_toxicology
    - name: nonteratogenic_effects
    - name: nursing_mothers
    - name: openfda
    - name: other_safety_information
    - name: overdosage
    - name: package_label_principal_display_panel
    - name: patient_medication_information
    - name: pediatric_use
    - name: pediatric_use_table
    - name: pharmacodynamics
    - name: pharmacodynamics_table
    - name: pharmacogenomics
    - name: pharmacokinetics
    - name: pharmacokinetics_table
    - name: precautions
    - name: precautions_table
    - name: pregnancy
    - name: pregnancy_or_breast_feeding
    - name: pregnancy_table
    - name: purpose
    - name: purpose_table
    - name: questions
    - name: recent_major_changes
    - name: recent_major_changes_table
    - name: references
    - name: references_table
    - name: set_id
    - name: spl_medguide
    - name: spl_medguide_table
    - name: spl_patient_package_insert
    - name: spl_patient_package_insert_table
    - name: spl_product_data_elements
    - name: spl_unclassified_section
    - name: spl_unclassified_section_table
    - name: stop_use
    - name: storage_and_handling
    - name: teratogenic_effects
    - name: use_in_specific_populations
    - name: use_in_specific_populations_table
    - name: user_safety_warnings
    - name: version
    - name: warnings
    - name: warnings_and_cautions
    - name: warnings_table
    - name: when_using

Sample Rows

label.json

100 parsed rows. 20260907135233-9f179e3cc9ea