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 February 3, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    (in each tablet)            

    Acetaminophen USP 500 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    Temporary 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. The maximum daily dose of this product is 6 tablets (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 every day while using this product
  • 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.

  • 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 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 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 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 end panel for lot number and expiration date.
  • Inactive Ingredients

    Povidone, Pregelatinized Starch, Sodium Carboxymethyl Starch, Stearic Acid

    Distributed by:
    Marlex Pharmaceuticals, Inc.
    New Castle, DE 19720

  • Principal Display Panel

    NDC 10135-152-01
    ACETAMINOPHEN
    500 MG

    Principal Display Panel NDC 10135-152-01 ACETAMINOPHEN 500 MG

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code MLX;152
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-152-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/1997
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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