PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) LIQUID [EQUATE (WAL-MART STORES, INC.)]

PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) LIQUID [EQUATE (WAL-MART STORES, INC.)]
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NDC 49035-278-08
Set ID 872c5220-a379-4dc1-b99c-f11ebb82db35
Category HUMAN OTC DRUG LABEL
Packager EQUATE (Wal-Mart Stores, Inc.)
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each 15 mL)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • the common cold
      • headache
      • backache
      • minor pain or 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 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks ever 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.

    Ask a doctor before use if you have

    liver disease.

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • 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

    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 (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)
    • do not take more then 4 doses in any 24 hours period
    • measure only with dosing cup provided. Do not use any other dosing device
    • mL=milliliter
    • keep dosing cup with product
    • adults and children 12 years and over
      • 30 mL every 6 hours while symptoms last
      • do not take more than 10 days unless directed by a doctor
    • children under 12 years: do not use 
  • Other information

    • each 15 mL contains:sodium 6 mg 
    • store between 20-25ºC (68-77ºF) do not refrigerate
    • protect from light
  • Inactive ingredients

    citric acid, D&C red 33, FD&C red 40, flavors, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

  • Questions or comments?

    Call 1-888-287-1915

  • Principal Display Panel

    Compare to Tylenol® Extra Strength Active Ingredient*

    Adult Extra Strength

    Pain Reliever

    Acetaminophen 500 mg per 15 mL

    Pain reliever, fever reducer

    • For ages 12 years and over
    • Alcohol free

    CHERRY FLAVOR

    FL OZ (mL)

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

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

    DISTRIBUTED BY: Wal-Mart Inc.,

    Bentonville, AR 72716

  • Product Label

    Acetaminophen 500 mg

    EQUATE Pain Reliever Extra Strength Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-278
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-278-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/31/2015
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)