Label: EQUATE PAIN RELIEVER ACETAMINOPHEN FOR ADULTS 250 MG- acetaminophen bar, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 21, 2024

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  • Active ingredient (in each chewable bar)

    Acetaminophen 250mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    Liver warning:this product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000mg of acetaminophen in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 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 you have

    • liver disease
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • 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 Control Center right away (1-800-222-1222). 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 give more than directed (see overdose warning)
     Age (yrs.)Dose (chewable bar)
     Adults and children 12 years and over
    • take 4 chewable bars every 6 hours while symptoms last
    • do not take more than 12 chewable bars in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
     Children under 12 years ask a doctor

  • Other information

    • each chewable bar contains: potassium 5mg, sodium 16mg.
    • Store in a cool dry place between 20-25°C (68-77°F).
    • Child Resistant Container;do not use if printed seal under cap is broken or missing.
  • Inactive ingredients:

    ammonium glycyrrhizate, FD & C yellow #6, flavors, geleol mono and diglycerides, glucose syrup, hydroxypropyl betadex, maltitol solution, maltodextrin, menthol, neotame, polyethylene glycol 400, povidone, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

  • Questions or comments?

    Call 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    U.S. Patent 11,273,123

  • Principal Display Panel - Equate Pain Reliever Acetaminophen for Adults 250 mg-Orange Vanilla Flavor

    NDC 79903-247-40

    equate™

    Compare to Tylenol ®active ingredient**

    Pain Reliever Acetaminophen for Adults 250 mg

    Pain Reliever/Fever Reducer

    Contains No Aspirin

    Soft Chew Bars

    Orange Vanilla Flavor

    250 mg EACH 40 CHEWABLE BARS

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

    Equate Pain Reliever Acetaminophen for Adults 250 mg

  • INGREDIENTS AND APPEARANCE
    EQUATE PAIN RELIEVER ACETAMINOPHEN FOR ADULTS 250 MG 
    acetaminophen bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-247
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    NEOTAME (UNII: VJ597D52EX)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCROSE (UNII: C151H8M554)  
    MALTITOL (UNII: D65DG142WK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColororangeScoreno score
    ShapeRECTANGLESize25mm
    FlavorORANGE (Orange Vanilla Flavor) Imprint Code O
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-247-4040 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/01/2024
    Labeler - Walmart Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    USpharma Ltd080664601manufacture(79903-247)
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