Home > Drugs A-Z > ACETAMINOPHEN

ACETAMINOPHEN (TIME CAP LABS INC)

Available Formats

Dosage Form Package Information Links
TABLET 100 TABLET in 1 BOTTLE, PLASTIC (49483-252-01) Label Information

Complete ACETAMINOPHEN Information

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Acetaminophen 500 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses
    • temporarily relieves minor aches and pains due to:
      • the common cold
      • headache
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever

  • WARNINGS

    Warnings
    Liver warning:
    This product contains acetaminophen. Severe liver damage may occur if you have:
    • 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

    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 DOCTOR

    Ask a doctor before use if you have
    • liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    • taking the blood thinning drug warfarin

  • STOP USE

    Stop use and ask a doctor if
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present
    These could be signs of a serious condition.

  • 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.

  • OVERDOSAGE

    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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions
    • do not take more than directed (see overdose 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 ng) 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 (overdose) of acetaminophen and may cause liver damage

  • STORAGE AND HANDLING

    Other information
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package

  • INACTIVE INGREDIENT

    Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
    *may contain this ingredient

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF BOTTLE LABELEnter section text here


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-252
    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
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code TCL252
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-252-01 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 07/12/2011
    Labeler - TIME CAP LABS INC (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABS INC 037052099 manufacture