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Pain Relief Maximum Strength (Select Corporation)

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TABLET, COATED 2 TABLET, COATED in 1 PACKET (52904-468-02) Label Information

Complete Pain Relief Maximum Strength Information

  • ACTIVE INGREDIENT

    Active Ingredients

    Acetaminophen 250 mg
    Aspirin 250 mg
    Caffeine 65 mg




  • PURPOSE

    Pain Reliever, Fever Reducer


  • 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


  • INDICATIONS & USAGE

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


  • 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
  • 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.


  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.


  • INACTIVE INGREDIENT

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


  • PRINCIPAL DISPLAY PANEL

    MM1

    Pain Max packet


  • 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)