Label: NON-ASPIRIN - acetaminophen tablet

  • 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 December 30, 2017

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

  • Active Ingredient (in each tablet)

    Acetaminophen 325 mg

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  • Purpose

    Analgesic/antipyretic

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  • Uses


    temporary relief of minor aches and pains associated with:

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

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  • 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

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  • 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;  for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor

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  • ASK DOCTOR

    Ask a doctor before use if the user has liver disease

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

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  • STOP USE

    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

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    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 symptoms.  Do not exceed recommended dosage

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  • Inactive Ingredients

    Cornstarch, polyethylene glycol, stearic acid, povidone

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  • DOSAGE & ADMINISTRATION

    Directions

    Adults and Children                        Take 2 tablets every 4 to 6 hours as

    12 years of age                               needed.  Do not take more than 12 tablets

    or older                                          in 24 hours.



    Children 6-11 years                           Take 1 tablet every 4 to 6 hours as

    of age                                               needed.  Do not take more than 5

                                                            tablets in 24 hours.



    Children under 6                                Do not use this regular strength product.

    years of age                                      This will provide more than the

                                                             recommended dose (overdose) and could

                                                             cause serious health problems.

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  • STORAGE AND HANDLING

    Store at 59-86 degree F (15-30 degree C)


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  • GENERAL PRECAUTIONS

    tamper evident sealed packets; do not use any open or torn packets

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  • DESCRIPTION

    Distributed by GENUINE FIRST AID
    600 Cleveland Str Suite 400, Clearwater, FL 33755

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  • INGREDIENTS AND APPEARANCE
    NON-ASPIRIN  
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0010
    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)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white (WHITE) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code AZ;234
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0010-1 2 in 1 PACKAGE; Type 0: Not a Combination Product 04/23/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/23/2010
    Labeler - Genuine First Aid LLC (619609857)
    Establishment
    Name Address ID/FEI Business Operations
    Future Pak Ltd. 087737672 manufacture(52124-0010)
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