Label: PAIN AND FEVER- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/15

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

  • Active Ingredients (in each tablet)

    Acetaminophen USP, 325 mg

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  • Purposes

    Pain reliever/fever reducer
    Relieves Pain & Fever without Aspirin

    Regular Strength Tablets

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  • Uses

    temporarily reduces fever and relives minor aches and pains caused by

    Headache
    muscular aches
    common cold
    toothache
    premenstrual and menstrual cramps
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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 tablets in 24 hours, which is the maximum daily amount
    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 non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if the user has

    liver disease

    Ask a doctor or pharmacist before use if the user is

    taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    adult's pain gets worse or lasts more than 10 days
    child's pain gets worse or lasts more than 5 days
    fever gets worse or lasts more than 3 days
    redness or swelling is present
    any new symptoms appear

    These could be signs of a serious condition.

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

    Keep out of reach of children

    In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

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  • Directions

    Adults and children 12 years and over

    1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours.

    Children 6 to 11 years

    1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours.

    Children under 6 years

    do not use

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  • Other information

    store at room temperature

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  • Inactive Ingredients

    pregelatinized corn starch, povidone, sodium starch glycolate, stearic acid

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  • Questions or comments?

    call 1-800-645-2158

    COMPARE TO ACTIVE INGREDIENT IN REGULAR STRENGTH TYLENOLR*

    *Rugby Laboratories, Inc. is not affiliated with the owner of the trademark TylenolR.

    www.rugbylaboratories.com

    Distributed By: Rubgy Laboratories

    31778 Enterprise Drive, Livonia, MI 48150

    Rev. 04/13

    IT48470180215

    Cardinal Health

    Zanesville, OH 43701

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  • Principal Display Panel

    PAIN & FEVER

    Acetaminophen USP

    325 mg tablets

    card label
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  • Principal Display Panel

    PAIN & FEVER

    Acetaminophen USP, 325 mg tablets

    REGULAR STRENGTH

    QTY 30

    lidding label
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  • Principal Display Panel

    Pain & Fever

    Acetaminophen USP

    325 mg tablets

    card label
    Close
  • Principal Display Panel

    Pain & Fever

    Acetaminophen USP, 325 mg tablets

    Regular Strength

    QTY 28

    lidding label
    Close
  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-6814(NDC:0536-3222)
    Route of Administration ORAL DEA Schedule     
    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)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score no score
    Shape ROUND (round flat faced beveled edge) Size 10mm
    Flavor Imprint Code GPIA325
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-6814-9 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:55154-6814-3 28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 02/23/2011
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-6814)
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