PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SELECT CORPORATION]

PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SELECT CORPORATION]
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NDC 52904-446-02
Set ID bfae4ae0-71f0-4ad7-97b2-84498ec6a41b
Category HUMAN OTC DRUG LABEL
Packager Select Corporation
Generic Name
Product Class
Product Number
Application Number PART343
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-446
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorwhite (snow white) Scoreno score
    ShapeROUND (AZ235) Size12mm
    FlavorImprint Code AZ235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-446-022 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/15/2012
    Labeler - Select Corporation (053805599)
    Registrant - Select Corporation (053805599)

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