Label: PAIN RELIEF MAXIMUM STRENGTH - acetaminophen,aspirin,caffeine tablet, coated

  • 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 October 15, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients

    Acetaminophen 250 mg
    Aspirin 250 mg
    Caffeine 65 mg



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  • PURPOSE

    Pain Reliever, Fever Reducer

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  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and older: 2 tablets as
    needed for pain every 6 hours. Do not exceed 8 tablets in 24 hours or as
    directed by a doctor. Children under 12 years: Consult a doctor

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  • INDICATIONS & USAGE

    Uses: temporarily relieves minor aches and pains associated with:
    • backache • headaches • colds • toothache • minor arthritis pain
    • muscular aches

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  • WARNINGS

    Warnings: Reye's syndrome:
    Children and teenagers should not use this medicine for chicken pox or
    flu symptoms before a doctor is consulted about Reye's syndrome, a
    rare but serious illness reported to be associated with aspirin. Allergy
    Alert-Do not use: • if you are allergic to aspirin or any other salicylate •
    If you have ever had an allergic reaction to any other pain
    reliever/fever reducer Liver Warning: This product contains
    acetaminophen. Severe liver damage may occur if you take: • more
    than 8 tablets in 24 hours • with other drugs containing acetaminophen
    (prescription or nonprescription). Ask a doctor or pharmacist before
    using with other drugs if you are not sure. • 3 or more alcoholic drinks
    every day while using this product Stomach Bleeding Warning: This
    product contains nonsteroidal antiinflammatory dugs (NSAIDs), which
    may cause stomach bleeding. The chance is higher if you: • are age 60
    or older • have had stomach ulcers or bleeding problems • take a blood
    thinning (anticoagulant) or steroid drug • take other drugs containing an
    NSAID (aspirin, ibuprofen, naproxen, or others). • Take more or for a
    longer time than directed Do not use: • if you are allergic to aspirin
    • with any other pain reliever/fever reducer • if you have
    ever had an allergic reaction to any other pain
    reliever/fever reducer • for pain for more than 10 days or for
    fever for more than 3 days unless directed by a doctor • with
    any other product containing acetaminophen Ask doctor
    before using if you have: • asthma • stomach problems (such as
    heartburn, upset stomach or stomach pain) • gastric ulcers • bleeding
    problems Ask a doctor or pharmacist before use if you are taking a
    prescription drug for: • anticoagulation (thinning of blood) • diabetes •
    gout • arthritis. When using this product do not exceed recommended dose.
    Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs
    • pain or fever persists or gets worse • new symptoms occur • redness or
    swelling is present Close
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health
    professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE
    ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS
    SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT
    MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR
    COMPLICATIONS DURING DELIVERY.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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  • INACTIVE INGREDIENT

    IInactive Ingredients: Hydroxypropyl Methylcellulose, Maltodextrin,
    Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch
    Glycolate, Starch, Stearic Acid, Titanium Dioxide

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  • PRINCIPAL DISPLAY PANEL

    MM1

    Pain Max packet

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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF MAXIMUM STRENGTH  
    acetaminophen,aspirin,caffeine tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-468
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (snow white) Score no score
    Shape ROUND (FR9) Size 12mm
    Flavor Imprint Code FR9
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52904-468-02 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 10/15/2012
    Labeler - Select Corporation (053805599)
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