Label: PAIN RELIEVER FEVER REDUCER EXTRA STRENGTH- acetaminophen liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 6, 2024

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  • 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 of arthritis
      • toothache 
      • muscular ache
      • premenstrual and menstrual cramps  
    • temporarily reduces fever
  • Warnings

    Liver warning:  This product contains acetaminophen. The maximum daily dose of this product is 90 mL (6 tbsp) (3,000 mg) in 24 hours. 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Extra Strength Tylenol®*

    EXTRA STRENGTH

    Acetaminophen, Liquid 500 mg

    Pain reliever; Fever reducer

    For Ages 12 & over

    Cherry flavor

    FL OZ (mL)

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

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

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, PI 02895

    CVS.com

  • Product Label

    Acetaminophen 500 mg

    CVS HEALTH Extra Strength Acetaminophen Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER FEVER REDUCER  EXTRA STRENGTH
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-878
    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:69842-878-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/30/2018
    Labeler - CVS Pharmacy (062312574)