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Acetaminophen (New World Imports, Inc)

Available Formats

Dosage Form Package Information Links
TABLET 1000 TABLET in 1 BOTTLE (51824-010-10) Label Information
TABLET 1000 TABLET in 1 BOTTLE (51824-010-10) Label Information
TABLET 100 TABLET in 1 BOTTLE (51824-010-01) Label Information
TABLET 100 TABLET in 1 BOTTLE (51824-010-01) Label Information

Complete Acetaminophen Information

  • ACTIVE INGREDIENT

    Acetaminophen 325mg


  • PURPOSE

    Pain reliever / Fever reducer


  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or problems.


  • INDICATIONS & USAGE

    Temporary relief of minor aches and pains associated with:

    common cold, headache, toothache, muscular aches, backache, arthritis, menstrual cramps, and reduction of fever


  • WARNINGS

    Liver warning: This product contains acetaminophen.  Severe liver damage may occur if:

    Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount

    Child takes more than 5 doses in 24 hours

    Taken with other drugs containing acetaminophen

    Adult has 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.

    Ask a doctor before use if user has: liver disease

    Ask a doctor or pharmacist before use if:the user is taking the blood thinnig drug warfarin.

    Stop use and ask a doctor if: Symptoms do not improve.  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.  A rare sensitivity reaction occurs. You may report side effects to 1-888-952-0050

    If pregnant or breast-feeding,ask a health professional before use. 

    Do not exceed recommended daily dosage.


  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours as needed.  Do not take more than 12 tablets in 24 hours.

    Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.  Do not take more than 5 tablets in 24 hours.

    Children under 6 years of age: Do not sue this regular strength product.  This will provide more than the recommended dose (overdose) and could cause serious health problems.


  • INACTIVE INGREDIENT

    Corn starch, pregelatinized starch, stearic acid.  May contain povidone and sodium starch glycolates.


  • label

    Label


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-010
    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
    Starch, Corn (UNII: O8232NY3SJ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Povidone (UNII: FZ989GH94E)  
    Sodium starch glycolate type A potato (UNII: 5856J3G2A2)  
    Product Characteristics
    Color white (white ) Score no score
    Shape ROUND (Round Circle) Size 11mm
    Flavor Imprint Code AZ;010
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51824-010-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/10/2010 08/01/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/10/2010 08/01/2020
    Labeler - New World Imports, Inc (075372276)