Label: ACETAMINOPHEN tablet

  • 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 March 28, 2011

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  • Drug Facts

    Active ingredient (in each tablet)

    Acetaminophen .............................. 325 mg

  • PURPOSE

    Pain Reliever/ Fever Reducer

  • Uses

    Temporarily relieves minor aches and pains due to:

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

    temporarily reduces fever

  • Warnings

    Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

    Do not use with any other drug containing acetaminophen

    Stop use and ask a doctor if

    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

    Indicated for pain relief.

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

    Keep out of reach of children.

  • Overdose Warning:

    Taking more than the recommended dose (overdose) may cause liver damage. 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.

  • Directions: do not take more than directed (see overdose warning)

    adults and children 12 years and over
    • take 2 tablets every 4 to 6 hours while symptoms last
    • do not take more than 12 tablets in 24 hours
    • do not use more than 10 days unless directed by a doctor

    children 6 years to 11 years
    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours

    children under 6 years
    • do not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • Other Information

    • store between 20°- 25°C (68°- 77°F)
    • do not use if carton is opened
  • Inactive Ingredients

    povidone, pregelatinized starch, stearic acid

  • SPL UNCLASSIFIED SECTION

    Questions or Comments?
    Call 1-866-383-9908

    Manufactured by:

    Cispharma Inc
    1212 Cranbury S River Road
    Cranbury, NJ 08512

  • PRINCIPAL DISPLAY PANEL

    ACETAMINOPHEN TABLETS, 325 mg, Bulk
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52204-113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITE (White) Score2 pieces
    ShapeROUND (round) Size10mm
    FlavorImprint Code MLX;123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52204-113-9943956 in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/28/2011
    Labeler - Cispharma, Inc (833171445)
    Registrant - Cispharma, Inc (833171445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cispharma, Inc833171445manufacture
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