Label: APINOPHEN EXTRA STRENGTH- acetaminophen tablet 

  • NDC Code(s): 46084-061-11, 46084-061-22, 46084-061-23, 46084-061-24, view more
    46084-061-25, 46084-061-26
  • Packager: A P J Laboratories Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/14

If you are a consumer or patient please visit this version.

  • active ingredient

    Acetaminophen 500 mg

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  • purpose

    Pain reliever/fever reducer

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  • keep out of reach of children

    Overdose warning:

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • uses



    temporarily relieves minor aches and pains due to:

    the common cold
    headache
    backache
    minor pain of arthritis
    toothache
    muscular aches
    premenstrual and menstrual cramps
    temporarily reduces fever

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  • warning

    Liver warning:


    This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

    more than 4,000 mg of acetaminophen in 24 hours

    with other drugs containing acetaminophen

    3 or more alcoholic drinks every day while using this product

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  • directions

    do not take more than directed (see overdose warning)

    adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last
    swallow whole – do not crush, chew, or dissolve
    do not take more than 6 caplets in 24 hours, unless directed by a doctor
    do not use for more than 10 days unless directed by a doctor

    children under 12 years : ask a doctor

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  • INACTIVE INGREDIENT

    LACTOSE MONOHYDRATE

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  • INACTIVE INGREDIENT

    STARCH, CORN

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  • INACTIVE INGREDIENT

    GELATIN

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  • INACTIVE INGREDIENT

    METHYLPARABEN Close
  • INACTIVE INGREDIENT

    PROPYLPARABEN Close
  • INACTIVE INGREDIENT

    MAGNESIUM STEARATE Close
  • INACTIVE INGREDIENT

    TALC Close
  • INACTIVE INGREDIENT

    SODIUM STARCH GLYCOLATE TYPE A POTATO Close
  • INACTIVE INGREDIENT

    SILICON DIOXIDE

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  • PRINCIPAL DISPLAY PANEL

    productEnter section text here

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  • INGREDIENTS AND APPEARANCE
    APINOPHEN  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46084-061
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE 10 mg
    STARCH, CORN 17 mg
    GELATIN 2 mg
    METHYLPARABEN 10 mg
    PROPYLPARABEN 1 mg
    MAGNESIUM STEARATE 10 mg
    TALC 10 mg
    SODIUM STARCH GLYCOLATE TYPE A POTATO 20 mg
    SILICON DIOXIDE 1 mg
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 13mm
    Flavor Imprint Code 500mg
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46084-061-25 500 in 1 BLISTER PACK
    2 NDC:46084-061-24 250 in 1 BLISTER PACK
    3 NDC:46084-061-23 120 in 1 BLISTER PACK
    4 NDC:46084-061-22 60 in 1 BLISTER PACK
    5 NDC:46084-061-11 2 in 1 BLISTER PACK
    6 NDC:46084-061-26 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 03/01/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    Name Address ID/FEI Business Operations
    A P J Laboratories Limited 677378339 manufacture(46084-061)
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