Label: ACETAMINOPHEN tablet

  • 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 December 3, 2020

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  • Drug Facts

    Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • 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 4,000 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.

    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

    ■ 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.

    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

    ■ adults and children 12 years and over:

    ■ take 2 tablets every 6 hours while symptoms last

    ■ do not take more than 6 tablets 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

    ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    ■ see end flap for expiration date and lot number

  • Inactive ingredients

    povidone, pregelatinized starch, sodium starch glycolate and stearic acid

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED

    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by McNeil

    Consumer Healthcare, owner of the registered trademark

    Extra Strength Tylenol®.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2018 CVS/pharmacy CVS.com®

    1-800-SHOP CVS V-34571

  • PRINCIPAL DISPLAY PANEL

    CVSHealth

    Compare to the active ingredient in Extra Strength Tylenol®*

    EXTRA STRENGTH

    Acetaminophen

    Tablets 500 mg

    Pain reliever; Fever reducer

    Aspirin free

    100 TABLETS

    CVS Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-465
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code CPC;546
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-465-121 in 1 CARTON08/06/2018
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/06/2018
    Labeler - CVS Pharmacy, Inc. (062312574)
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