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ACETAMINOPHEN (TIME CAP LABORATORIES, INC)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-342-10) Label Information
TABLET, FILM COATED 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-342-01) Label Information
TABLET, FILM COATED 100000 TABLET, FILM COATED in 1 CARTON (49483-342-00) Label Information

Complete ACETAMINOPHEN Information

  • ACTIVE INGREDIENT

    Acetaminophen 500 mg



  • PURPOSE

    PURPOSE:  Pain Reliever - fever reducer


  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away


  • INDICATIONS & USAGE

    INDICATIONS AND USAGE:

    Pain Reliever – temporarily relieves minor aches and pains  due to:  the common cold, headache, backache, muscular aches,  toothache, premenstrual and menstrual cramps, minor pain of arthritis. Temporarily reduces 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; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen.

    Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage.  in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.




  • DOSAGE & ADMINISTRATION

    Do not take more than directed (see overdosage warning)

    Adults and children 12 years and over:  take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor; do not take for more than 10 days unless directed by a doctor

    Children under 12 years:  Do not use this adult extra strength product in children under 12 years of age, this will provide more than the recommended dose (overdosage) of acetaminophen and may cause liver damage




  • INACTIVE INGREDIENT

    CARNAUBA WAX, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, POLYETHYLENE GLYCOL(PEG) 400, POLYETHYLENE GLYCOL (peg) 8000, POVIDONE, PREGELATINIZED STARCH, SODIUM STARCH GLYCOLATE**, STEARIC ACID, SUCRALOSE, TITANIUM DIOXIDE



    ** MAY CONTAIN THIS INGREDIENT


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-342
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color red Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code TCL342
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-342-01 100 in 1 BOTTLE, PLASTIC
    2 NDC:49483-342-10 1000 in 1 BOTTLE, PLASTIC
    3 NDC:49483-342-00 100000 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/01/2012
    Labeler - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABORATORIES, INC 037052099 manufacture