Label: NON-ASPIRIN - acetaminophen tablet

  • NDC Code(s): 43459-0152-6, 43459-0153-6
  • Packager: Etex Pharm Co., Ltd
  • 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 June 30, 2010

If you are a consumer or patient please visit this version.

  • Active Ingredients (in each tablet)

                           

    Acetaminophen 500mg


    Close
  • Purpose

    Pain Reliever/fever reducer
    Close
  • 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.

    Close
  • 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 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
    Close
  • Other Information

    • do not use if imprinted safety seal under cap is broken or missing.
    • store between 20-25°C (68-77°F)
    • see end panel for lot number and expiration date
    Close
  • Inactive Ingredients

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

    Close
  • PRINCIPAL DISPLAY PANEL

    non-aspirin 50 tabletimage of carton label

    Close
  • Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • arthritis
    • the common cold
    • toothache
    • menstrual cramps
    • temporarily reduces fever
    Close
  • INGREDIENTS AND APPEARANCE
    NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43459-0153
    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:43459-0153-6 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
    NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43459-0152
    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:43459-0152-6 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 - Etex Pharm Co., Ltd (631034449)
    Registrant - Etex Pharm Co., Ltd (631034449)
    Establishment
    Name Address ID/FEI Business Operations
    Etex Pharm Co., Ltd 631034449 manufacture
    Close