Label: ACETAMINOPHEN tablet

  • NDC Code(s): 17714-012-01, 17714-012-10
  • Packager: Advance Pharmaceutical Inc.
  • 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 December 22, 2017

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  • Active Ingredient

    (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain Reliever / Fever Reducer

  • Uses

    temporarily reduces fever and relieves minor aches and pains caused by

    • common cold
    • headache
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • Warnings

    Liver warning: this product contains acetaminophen. Severe liver damage may occur if

    • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
    • child takes more than 5 tablets in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    do not use with any other drug containing acetaminophen (prescription or non prescription).        If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if the user has liver disease

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • adult’s pain gets worse or lasts more than 10 days
    • child’s pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

  • Directions

    adults and children 12 years and over 1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours
    children 6 to 11 years 1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours
    children under 6 yearsask a doctor
  • Other Information

    • store at 15-30 °C (59-86 °F)

    For Bulk package: This is a bulk package, dispense contents with a child-resistant closure in a tight, light resistant container as defined in the USP.

  • Inactive Ingredients

    polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

  • Questions or Comments

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    1d2e4055-figure-01

    1d2e4055-figure-02

    1d2e4055-figure-03

    NDC: 17714-012-01 – 100 COUNT

    NDC: 17714-012-10 – 1000 COUNT

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code AP;012
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-012-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/05/1989
    2NDC:17714-012-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/05/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/05/1989
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-012)
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