Label: ACETAMINOPHEN 325MG- acetaminophen tablet

  • NDC Code(s): 10135-123-01
  • Packager: Marlex Pharmaceuticals 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 18, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each tablet)

    Acetaminophen USP 325 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 10 tablets (3,250 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.

    Drug Facts (continued)

    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 12 tablets in 24 hours, unless directed by a doctor.
    • Do not use for more than 10 days unless directed by a doctor.

    Children 6-11 years:

    • Take 1 tablet every 4 to 6 hours while symptoms last.
    • Do not take more than 5 tablets in 24 hours.

    Children under 6 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 10135-0123-01
    Acetaminophen
    325 mg

    100 TABLETS

    PRINCIPAL DISPLAY PANEL
NDC 10135-0123-01
Acetaminophen
325 mg
100 TABLETS

    PRINCIPAL DISPLAY PANEL
NDC 10135-0123-01
Acetaminophen
325 mg
100 TABLETS

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 325MG 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-123
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code MLX123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-123-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34304/01/2018
    Labeler - Marlex Pharmaceuticals Inc (782540215)