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

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, RI 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 (24 Tablets Bottle)

CVSHealth®                   Tablets
NDC 69842-635-07


8HR Muscle
Aches & Pain
ACETAMINOPHEN
EXTENDED-RELEASE
TABLETS USP, 650 mg
Pain Reliever/Fever Reducer 


DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN


24 EXTENDED-RELEASE
TABLETS 650 mg EACH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablet Bottle)

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

CVS Health®                                               Compare to the active ingredient in
                                                                     Tylenol® 8HR Muscle Aches & Pain*
                                                                                                                                                             
                                                                                          Tablets

                                                                                   NDC 69842-635-07

8HR Muscle Aches & Pain
ACETAMINOPHEN


EXTENDED-RELEASE TABLETS USP, 650 mg
Pain Reliever/Fever Reducer

For up to 8 hours of relief of minor
muscle aches & pain

Contains No Aspirin


24 EXTENDED-RELEASE
TABLETS 650 mg EACH                                                              

DO NOT USE WITH
OTHER MEDICINES
CONTAINING
ACETAMINOPHEN

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (150 Tablets Container Carton)


ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-635
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:69842-635-071 in 1 CARTON10/13/2022
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20722910/13/2022
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(69842-635) , MANUFACTURE(69842-635)

Revised: 1/2024
Document Id: 8394aaec-e897-48bb-bda2-cc2b64a6cd64
Set id: e577fdf0-85b1-1471-e053-2995a90a6fcd
Version: 5
Effective Time: 20240124
 
CVS Pharmacy, Inc.