Label: ACETAMINOPHEN tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 24, 2024

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  • Drug Facts

    Active ingredient (in each extended-release tablet)
    Acetaminophen USP 650 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • minor pain of arthritis
      • muscular aches
      • backache
      • premenstrual and menstrual cramp toothache
      • the common cold
      • headache
      • toothache
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 6 tablets in 24 hours, which is the maximum daily amount
    • 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 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: 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:

    • take 2 tablets every 8 hours with water
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 tablets in 24 hours
    • do not use for more than 10 days unless directed by a doctor.

    Under 18 years of age:

    • ask a doctor
  • Other information

    • store at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). 
    • USP Dissolution test is pending 
  • Inactive ingredients

    colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

    Questions or comments?     call 1-888-287-1915
    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716

    Made in India
    Code: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (325 Tablet Bottle)

    TO OPEN: 1.  PUSH DOWN                    NDC 79903-132-25
                       2.  TURN CAP
    equateTM

    Compare
    to Tylenol®
    8 HR Arthritis
    Pain active
    ingredient**

    8 HOUR Arthritis
    Pain Relief
    Acetaminophen Extended-Release
    Tablets USP, 650 mg

    Pain Reliever/Fever Reducer
    For the Temporary Relief of Minor Arthritis Pain

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
                                                        650                    325
                                                        mg                 Extended-Release     
                                                        EACH           Tablets
    Actual Size                          


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (325 Tablet Bottle)

         



  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-132
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITE (White to Off-White) Scoreno score
    ShapeCAPSULE (Caplet) Size19mm
    FlavorImprint Code I;06
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-132-25325 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20722907/26/2022
    Labeler - WALMART INC. (051957769)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(79903-132) , MANUFACTURE(79903-132)
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