ACETAMINOPHEN - acetaminophen tablet, extended release 
CVS Pharmacy, Inc.

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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: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, Rl 02895
©2023 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

Made in India

Code: TS/DRUGS/22/2009

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

CVS
Health®

Compare to the active ingredient
in Tylenol® 8HR Arthritis Pain*
Tablets
NDC 69842-037-35

8HR Arthritis
Pain Relief

ACETAMINOPHEN
EXTENDED-RELEASE TABLETS,
USP 650 mg

Pain Reliever/Fever Reducer

For the temporary relief of
minor arthritis pain

Actual
Size

TO OPEN:
1. PUSH DOWN
2. TURN CAP


225 EXTENDED-
RELEASE TABLETS

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

figure 1

ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-037
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:69842-037-911 in 1 CARTON12/23/202009/25/2023
1150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69842-037-35225 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2020
3NDC:69842-037-44400 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20722912/23/2020
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(69842-037) , MANUFACTURE(69842-037)

Revised: 1/2024
Document Id: 3ac76330-16d2-44f6-b013-8683059b83a9
Set id: b70beee4-407e-547c-e053-2a95a90af22a
Version: 8
Effective Time: 20240124
 
CVS Pharmacy, Inc.