Label: ACETAMINOPHEN tablet, film coated

  • NDC Code(s): 69842-864-04, 69842-864-05
  • Packager: CVS Pharmacy, Inc
  • 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 October 27, 2021

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  • Drug Facts

    Active ingredient (in each caplet)
    Acetaminophen 500 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer

  • Uses

     temporarily relieves minor aches and pains due to  the common cold  headache  toothache
     muscular aches

     backache

     minor pain of arthritis

     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 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.

     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

     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 take more than directed (see overdose warning).

    adults and children
    12 years of age
    and over     		 take 2 caplets every 6 hours while symptoms last
     do not take more than 6 caplets 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 of age     		 ask a doctor

  • Other information

     Store in a dry place at 15° – 30°C (59° – 86°F)

  • INACTIVE INGREDIENT

    corn starch, hypromellose, mineral oil, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    Call 1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2021 CVS/pharmacy

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

  • PRINCIPAL DISPLAY PANEL

    CVS Health

    Compare to the active ingredient in Extra Strength Tylenol®*

    Extra Strength

    Acetaminophen

    Caplets 500 mg

    Pain reliever; Fever reducer

    1000 Caplets

    CVS Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-864
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code CPC1190
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-864-041000 in 1 BOTTLE; Type 0: Not a Combination Product03/17/2021
    2NDC:69842-864-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/17/2021
    Labeler - CVS Pharmacy, Inc (062312574)
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