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Pain Relief Extra Strength (Select Corporation)

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TABLET 2 TABLET in 1 PACKET (52904-446-02) Label Information

Complete Pain Relief Extra Strength Information

  • ACTIVE INGREDIENT

    Active Ingredients

    Acetaminophen 500mg

  • PURPOSE

    Analgesic, Antipyretic


  • DOSAGE & ADMINISTRATION

    Directions: Adults and children
    12 years of age and older: take 2 tablets every 4 to 6 hours
    as needed do not take more than 8 tablets in 24 hours. Children
    under 12 years of age: do not use this extra strength product; this
    will provide more than the recommended dose (overdose) and
    could cause serious health problems.


  • INDICATIONS & USAGE

    Uses: temporary relief of minor aches and pains associated with
    common cold headache backache arthritis toothache
    muscular aches menstrual cramps and reduction of fever


  • WARNINGS

    Warnings:
    Liver warning: This product contains acetaminophen. Severe
    liver damage may occur if you take more than 8 tablets in 24
    hours, which is the maximum daily amount with other drugs
    containing acetaminophen 3 or more alcoholic drinks every
    day while using this product Do not use: with any other drug
    containing acetaminophen (prescription or nonprescription). If you
    are not sure whether a drug contains acetaminophen, ask a doctor
    or pharmacist. Ask a doctor before use if you have: liver
    disease. Ask a doctor or pharmacist before use if you are:
    taking the blood thinning drug warfarin. Stop use and ask a
    doctor if: pain gets worse or lasts for more than 10 days a
    rare sensitivity reaction occurs fever gets worse or lasts more
    than 3 days symptoms do not improve new symptoms occur
    redness or swelling is present. You may report side effects to
    888-952-0050.


  • PREGNANCY OR BREAST FEEDING

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


  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.


  • INACTIVE INGREDIENT

    Inactive ingredients: corn starch, hydoxypropyl methylcellulose,
    polyethylene glycol, pregelatinized starch, stearic acid, titanium
    dioxide. May contain povidone and sodium starch glycolate


  • PRINCIPAL DISPLAY PANEL

    MM1

    Pain ES Packet


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF EXTRA STRENGTH 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-446
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    Product Characteristics
    Color white (snow white) Score no score
    Shape ROUND (AZ235) Size 12mm
    Flavor Imprint Code AZ235
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52904-446-02 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)
    Registrant - Select Corporation (053805599)