Label: ACETAMINOPHEN tablet, film coated

  • NDC Code(s): 57237-347-01, 57237-347-05
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2025

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

    Active Ingredient (in each caplet)                                    Purpose

    Acetaminophen USP, 500 mg........................................Pain Reliever/Fever Reducer

  • PURPOSE

  • Uses

    • temporarily relieves minor aches and pains due to:
    • the common cold 
    • headache 
    • backache
    • minor pain from 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 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
    • 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.

    Overdose warning: 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.

  • DOSAGE & ADMINISTRATION

    aceta-500mg-directions

    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 or comments? Call 1-844-474-7464

    †This product is neither manufactured nor distributed by the owner of the registered trademark Tylenol® Extra Strength.

    Distributed by:
    Rising Pharma Holdings, Inc.

    East Brunswick, NJ 08816

    Made in India

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Extra Strength

    Acetaminophen

    500 mg

    NDC 57237-347-05

    500 Film Coated Caplets

    aceta-500mg-500ct

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-347
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 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
    ShapeCAPSULESize18mm
    FlavorImprint Code S500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-347-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/09/2025
    2NDC:57237-347-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/04/2025
    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(57237-347) , label(57237-347) , manufacture(57237-347) , pack(57237-347)
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