Label: ACETAMINOPHEN tablet, film coated

  • NDC Code(s): 57237-346-01, 57237-346-10
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 22, 2025

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

  • DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Drug Facts

    Active Ingredient (in each tablet)                          Purpose
    Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer

  • PURPOSE

  • Uses

    To reduce fever and for the temporary relief of 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.

    Severe liver damage may occur if

    • adult takes more than 10 tablets in 24 hours, which is the maximum daily amount 
    • child takes more than 5 tablets in 24 hours 
    • taken with other drugs containing acetaminophen
    • adult has 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 DOCTOR

    Ask a doctor before use if you have liver disease.

  • ASK DOCTOR/PHARMACIST

    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 in adults and children.
    • 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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). 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 4 to 6 hours while symptoms last.
    • do not take more than 10 tablets in 24 hours.
    • do not take 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 a doctor

    Children under 6 years:
    ask a doctor

    Other Information

    • SODIUM FREE
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • see end panel for lot number and expiration date.
  • Inactive Ingredients

    Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide.

  • QUESTIONS

    Questions and Comments? Call 1-844-474-7464

    Distributed by:

    Rising Pharma Holdings, Inc.

    East Brunswick, NJ 08816

    Made in India

    Mfg. Lic. No.: G/25/2258

    Issued: 06/2025 (S-065)

    Issued: 07/2025 (S-069-00)

    This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark Tylenol® Regular strength.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Acetaminophen

    325 mg

    100 Film Coated Tablets

    acetaminophen-325mg-label

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Acetaminophen

    325 mg

    1000 Film Coated Tablets

    acetaminophen-325mg-1000ct.jpg

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-346
    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 (Off White) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-346-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/09/2025
    2NDC:57237-346-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/09/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/09/2025
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Registrant - Elysium Pharmaceuticals Ltd (863182240)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd863182240analysis(57237-346) , label(57237-346) , manufacture(57237-346) , pack(57237-346)