Label: ACETAMINOPHEN tablet, extended release

  • NDC Code(s): 21130-108-07, 21130-108-35
  • Packager: Better Living Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 24, 2024

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

  • 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 cramps
      • 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). 
    • do not use if carton is opened or foil inner seal is broken
    • 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 1-855-274-4122

    DISTRIBUTED BY
    BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASONTON, CA 94566-0009
    1-888-723-3929
    www.betterlivingbrandsLLC.com

    MADE IN INDIA

    CODE: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Bottle)

    TO OPEN:
    1. PUSH DOWN
    2. TURN CAP

    Signaturte
    Care®                            
    Quality
    Guaranteed

    DO NOT USE
    WITH OTHER
    MEDICINES
    CONTAINING
    ACETAMINOPHEN

    8 HOUR                                
    NDC 21130-108-35
    ARTHRITIS
    PAIN
    RELIEVER

    ACETAMINOPHEN

    Extended-Release Tablets USP, 650 mg
    Pain Reliever/Fever Reducer

    For the temporary relief of                 225
    minor arthritis pain                  Extended-Release
                                                         Tablets
          
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Bottle)    

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Container Carton)

    Compare to Tylenol®8HR Arthritis Pain
    active ingredient*

    NDC 21130-108-35

    Signature
    Care®

    Quality Guaranteed

    DO NOT USE WITH
    OTHER MEDICINES
    CONTAINING
    ACETAMINOPHEN


    8 HOUR

    ARTHRITIS
    PAIN 
    RELIEVER
    ACETAMINOPHEN
                            Actual Size
    Extended-Release                                06
    Tablets USP, 650 mg
    Pain Reliever/Fever Reducer

    For the temporary relief                225
    of minor arthritis pain       Extended-release
                                                   tablets
     


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton)






  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-108
    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:21130-108-071 in 1 CARTON06/24/2022
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:21130-108-351 in 1 CARTON06/24/2022
    2225 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20722906/24/2022
    Labeler - Better Living Brands, LLC (009137209)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(21130-108) , MANUFACTURE(21130-108)