ACETAMINOPHEN - acetaminophen tablet, extended release 
Better Living Brands, LLC

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Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

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

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:


Under 18 years of age:


Other information

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)






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)

Revised: 1/2024
Document Id: 3cc99dcb-b853-48bb-95bb-41a14cf78711
Set id: de3d9840-4ada-5c9a-e053-2a95a90a5721
Version: 4
Effective Time: 20240124
 
Better Living Brands, LLC