Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 5, 2022

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

  • Active ingredient (in each 15 mL = 1 tablespoon)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
    • muscular aches
    • toothache
    • backache
    • minor pain of arthritis
    • the common cold
    • premenstrual and menstrual cramps
    • headache
    • 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 every day while using this product

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

    • blisters
    • rash
    • skin reddening

    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.

    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 more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
    • mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • adults and children 12 years and over
    • take 30 mL (2 TBSP) in the dosing cup provided every 6 hours while symptoms last
    • do not take more than 90 mL (6 TBSP) in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • each 30 mL dose cup contains: sodium 11 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    anhydrous citric acid, flavor, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium saccharin, sucralose

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    CVS 
    Health

    Compare to the active ingredient
    in Tylenol® Extra Strength*

    Liquid

    EXTRA STRENGTH
    Acetaminophen
    Liquid, 500 mg

    Pain reliever, Fever reducer
    •Aspirin Free  •Alcohol Free

    DYE FREE

    Cherry Flavor

    8 FL OZ (237 mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED
    NECK WRAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Johnson &
    Johnson Corporation, owner of the registered trademark Tylenol®
    Extra Strength.

    50844        REV0917A04519

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    ©2019 CVS/pharmacy CVS.com®
    1-800-SHOP CVS V-11112

    CVS Health 44-045

    CVS Health 44-045

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  EXTRA STRENGTH
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-945
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-945-19237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/15/2018
    Labeler - CVS PHARMACY (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(69842-945) , pack(69842-945)