Label: GEWORIN- acetaminophen, isopropylantipyrine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 9, 2023

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  • ACTIVE INGREDIENT

    Acetaminophen, Isopropylantipyrine

  • PURPOSE

    relief of: Headaches, Aches, Pain and Fever

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    ■ adult and children 15 years of age and older: 1 capsules three times a day

    ■ children under 15 years of age: ask a doctor

  • WARNINGS

    Warnings

    Do not use if carton is open or if printed bottle neck band or inner foil seal is broken.physician

    Keep out of the reach of children. This package contains enough drug to seriously harm a child. Do not use with other drugs containing acetaminophen.

    Use the smallest effective dose. Do not take more than the maximum daily dose. Overdose may result in severe or possibly fatal liver damage.

    Do not take if allergic to acetaminophen. Consult a doctor if: your symptoms last for more than 5 days or fever lasts more than 3 days or you develop allergic reactions such as wheezing, rash or itching.

    Ask a doctor or pharmacist before use if you: Are pregnant or breastfeeding, have chronic alcoholism; have a serious liver or kidney disease; use any other medications including natural health products, prescription drugs, salicylates or other pain and fever relief medications.

    In case of overdose, call a Poison Control Centre or doctor immediately, even if you do not notice any possible signs or symptoms such as increased sweating, nausea, vomiting, stomach pain, and loss of appetite.

  • INACTIVE INGREDIENT

    cellulose, corn starch, magnesium stearate, sodium starch glycolate

  • DOSAGE & ADMINISTRATION

    for oral use

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GEWORIN 
    acetaminophen, isopropylantipyrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN300 mg
    PROPYPHENAZONE (UNII: OED8FV75PY) (PROPYPHENAZONE - UNII:OED8FV75PY) PROPYPHENAZONE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeTRIANGLESize13mm
    FlavorImprint Code GR
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0036-110 in 1 PACKAGE; Type 0: Not a Combination Product02/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/11/2023
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569manufacture(72988-0036)