Label: ACETAMINOPHEN- 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 05/14

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

  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • the common cold
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever
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  • Warnings

    Liver warning: This product contains acetaminophen.  The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.  Severe liver damage may occur if

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses 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 nonprescription).  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

    • pain gets worse or lasts more than 10 days in adults and children
    • pain gets worse or lasts more than 5 days in children under 12 years
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    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.

    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.

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  • 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 while symptoms last
      • do not take more than 10 tablets in 24 hours
      • do not take for more than 10 days unless directed by a doctor
    • children 6-11 years
      • take 1 tablet every 4 to 6 hours while symptoms last
      • do not take more than 5 tablets in 24 hours
      • do not take for more than 5 days unless directed by a doctor
    • children under 6 years: ask a doctor


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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

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

    *may contain this ingredient

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  • Questions or comments?

     1-877-932-7948

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  • Principal Display Panel

    equaline®

    compare to Regular Strength Tylenol® active ingredient†

    NDC 41163-104-12

    regular strength

    pain relief

    • acetaminophen, 325 mg 

    • pain reliever/fever reducer

    • aspirin free

    100 tablets

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    DOES NOT CONTAIN GLUTEN

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Regular Strength Tylenol®.

    50844       REV1012C10412

    DISTRIBUTED BY SUPERVALU INC.
    EDEN PRAIRIE, MN 55344 USA

    Equaline 44-104

    Equaline 44-104


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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41163-104
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID  
    STARCH, CORN  
    POVIDONES  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;104
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41163-104-12 1 in 1 CARTON
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 07/13/1990
    Labeler - SUPERVALU INC. (006961411)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(41163-104)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(41163-104)
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