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Acetaminophen (TDS Pharm Co., Ltd)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE in 1 BOX (42912-0152-7) > 40 TABLET in 1 BOTTLE Label Information

Complete Acetaminophen Information

  • Active Ingredients (in each tablet)

                           

    Acetaminophen 500mg



  • Purpose

    Pain Reliever/fever reducer

  • 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 maxium 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.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

    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
    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    These could be sign of a serious condition

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children.

    Enter section text here

    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.  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 house as needed
    • do not take more than 8 tablets in 24 hours
    • do not use 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 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
                          

  • Other Information

    • do not use if imprinted safety seal under cap is broken or missing.
    • Store at 15° - 30°C (59° - 86°F)
    • see end panel for lot number and expiration date

  • Inactive Ingredients

    benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride


  • PRINCIPAL DISPLAY PANEL

    non-aspirin 50 tabletimage of carton label


  • Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • arthritis
    • the common cold
    • toothache
    • mentrual cramps
    • temporarily reduces fever

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42912-0153
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 500 mg
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code A500
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42912-0153-6 1 in 1 BOX
    1 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 08/01/2010
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42912-0152
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 500 mg
    Product Characteristics
    Color white Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code A500
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42912-0152-7 1 in 1 BOX
    1 40 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 07/15/2010
    Labeler - TDS Pharm Co., Ltd (689951176)
    Registrant - TDS Pharm Co., Ltd (689951176)
    Establishment
    Name Address ID/FEI Business Operations
    TDS Pharm Co., Ltd 689951176 manufacture