ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet 
CVS Pharmacy

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Drug Facts

Active ingredient (in each caplet)

Acetaminophen 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 a 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 (1800-222-1222) right away. 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

D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hydroxyethyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose povidone, pregelatinized starch, sodium lauryl sulfate


Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient of Tylenol® 8HR Muscle Aches & Pain

Extended-release

Pain Reliever

Acetaminophen 650 mg

Pain reliever/Fever reducer

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

Caplets*

(*capsule-shaped bi-layer tablets)

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Muscle Aches & Pain.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy Inc

one CVS Drive, Woonsocket RI 02895

Product Label

Acetaminophen 650 mg

CVS HEALTH 8HR Arthritis Pain Relief

ACETAMINOPHEN  EXTENDED RELEASE
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-093
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 511
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-093-101 in 1 BOX04/01/202004/30/2025
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:69842-093-241 in 1 BOX04/01/202004/30/2025
224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:69842-093-151 in 1 BOX04/01/202004/30/2025
3150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:69842-093-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/202004/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20703504/01/202004/30/2025
Labeler - CVS Pharmacy (062312574)

Revised: 11/2022
Document Id: 6d2d12fa-f4f2-494e-a20f-e887a56f35c8
Set id: f1f47da9-2002-4bc8-8d26-e66b7b403497
Version: 4
Effective Time: 20221121
 
CVS Pharmacy