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ACETAMINOPHEN (Cispharma, Inc)

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TABLET 43956 TABLET in 1 DRUM (52204-113-99) Label Information

Complete ACETAMINOPHEN Information

  • 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


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52204-113
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE (White) Score 2 pieces
    Shape ROUND (round) Size 10mm
    Flavor Imprint Code MLX;123
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52204-113-99 43956 in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 03/28/2011
    Labeler - Cispharma, Inc (833171445)
    Registrant - Cispharma, Inc (833171445)
    Establishment
    Name Address ID/FEI Business Operations
    Cispharma, Inc 833171445 manufacture