PAIN RELIEVER REGULAR STRENGTH (ACETAMINOPHEN) TABLET [EQUATE (WALMART STORES, INC.)]

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  • PAIN RELIEVER REGULAR STRENGTH (ACETAMINOPHEN) TABLET [EQUATE (WALMART STORES, INC.)]

PAIN RELIEVER REGULAR STRENGTH (ACETAMINOPHEN) TABLET [EQUATE (WALMART STORES, INC.)]
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NDC 49035-491-01
Set ID 028ec0f2-2da5-4b76-a48e-65640ef15405
Category HUMAN OTC DRUG LABEL
Packager EQUATE (Wal-Mart Stores, Inc.)
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/ fever reducer

  • Uses

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

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

    • adult takes more than 4000 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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away

    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 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
    • 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: In case of overdose, get medical help or contact a Poison Contorl Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

  • 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 use 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 use for more than 5 days unless directed by a doctor
    children under 6 years
    •  ask a doctor

  • Other information

    • store between 20-25ºC (68-77ºF)
  • Inactive ingredients

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

    *may contain this ingredient

  • Questions or comments?

    Call 1-888-287-1915 

  • Principal Display Panel

    Compare to Tylenol® Regular Strength Active Ingredient†

    Regular Strength

    Pain Reliever

    Acetaminophen

    Pain Reliever/ Fever Reducer

    For ages 6 years and over

    Tablets

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: Wal-Mart Stores, Inc.,

    Bentonville, AR 72716

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Regular Strength.

  • Product Label

    Acetaminophen 325 mg

    Equate Regular Strength Pain Reliever Tablets

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  REGULAR STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-491
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL340
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-491-011 in 1 BOX10/31/2015
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34310/31/2015
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)
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