Label: PENZAL Q- acetaminophen, ethenzamide, caffeine anhydrous tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 18, 2019

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  • ACTIVE INGREDIENT

    Acetaminophen, Caffeine Anhydrous, Ethenzamide

  • 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 11 to under 15 years of age: 1/2-2/3 capsules three times a day
    ■ children 8 to under 11 years of age: 1/2 capsules three times a day
    ■ children under 8 years of age: ask a doctor

  • WARNINGS

    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.

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

    Store at room temperature, 15–30°C (59–86°F).

  • INACTIVE INGREDIENT

    cellulose, corn starch, magnesium stearate, sodium starch glycolate

  • DOSAGE & ADMINISTRATION

    For oral use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    PENZAL Q 
    acetaminophen, ethenzamide, caffeine anhydrous tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0034
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ETHENZAMIDE (UNII: L929ZCK4BF) (ETHENZAMIDE - UNII:L929ZCK4BF) ETHENZAMIDE200 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN300 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code PenzalQ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0034-110 in 1 BLISTER PACK; Type 0: Not a Combination Product11/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/20/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0034)