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 28, 2020

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  • Active ingredient

    (in each Caplet)

    Acetaminophen, USP 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 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 the reach of children.

  • Overdose warning

    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)

    adults and children 12 years 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 use for more than 10 days unless directed by a doctor

    children under 12 years

    ask a doctor

  • Other information

    ■ store between 20-25°C (68-77°F).See USP Controlled Room Temperature

    ■ see end panel for lot number and expiration date

  • Inactive ingredients

    hydroxypropyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

  • PRINCIPAL DISPLAY PANEL

    24 count

  • PRINCIPAL DISPLAY PANEL

    50 count

  • PRINCIPAL DISPLAY PANEL

    100 count

  • PRINCIPAL DISPLAY PANEL

    500 count

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-650
    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)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code G551
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-650-2424 in 1 BOTTLE; Type 0: Not a Combination Product02/25/2016
    2NDC:68016-650-0550 in 1 BOTTLE; Type 0: Not a Combination Product02/25/2016
    3NDC:68016-650-10100 in 1 BOTTLE; Type 0: Not a Combination Product02/25/2016
    4NDC:68016-650-50500 in 1 BOTTLE; Type 0: Not a Combination Product02/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/25/2016
    Labeler - Pharmacy Value Alliance, LLC (101668460)
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