Label: ACETAMINOPHEN tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 23, 2025

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  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/Fever reducer

  • Uses:

    • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain from arthritis
    • the common cold 
    • toothache 
    • 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 for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if:

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adults has 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 the user has

    liver disease

  • Ask a doctor or pharmacist before use if the user is

    taking the blood thinning drug warfarin

  • Stop use and ask a doctor if:

    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • 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

    • adults and children 12 years and over:
    • take 2 tablets every 4 to 6 hours while symptoms last
    • do not take mote than 10 tablets in 24 hours, unless directed by doctor
    • do not use for more than 10 days unless directed by a doctor
    • children 6 years to under 12 years:
    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not use for more than 5 days unless directed by doctor
  • Other information

    • store between 20°-25°C (68°-77°F)
    • read all product information before using
    • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    Pregelatinized Starch, Polyvinyl Pyrrolidone, Microcrystalline Cellulose, Stearic acid powder,  Magnesium Stearate, Hypromellose-5 & 15, Polyethylene Glycol-400, Talc, Titanium Dioxide.

  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9 AM - 5 PM EST

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71679-305-0047000 in 1 DRUM; Type 0: Not a Combination Product09/23/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/23/2025
    Labeler - Health Pharma USA LLC (080804485)
    Registrant - Health Pharma USA LLC (080804485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd863182240manufacture(71679-305)
    Establishment
    NameAddressID/FEIBusiness Operations
    HHH PHARMA USA LLC062788820pack(71679-305)
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