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Acetaminophen (Advance Pharmaceutical Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 1000 TABLET in 1 BOTTLE (17714-012-10) Label Information
TABLET 100 TABLET in 1 BOTTLE (17714-012-01) Label Information

Complete Acetaminophen Information

  • 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 years ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:17714-012
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code AP;012
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17714-012-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/05/1989
    2 NDC:17714-012-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/05/1989
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 02/05/1989
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 manufacture(17714-012)