PAIN RELIEF REGULAR STRENGTH- acetaminophen tablet 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS 44-104

Active ingredient (in each tablet)

 Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

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

  • 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 the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • new symptoms occur
  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults and
children
12 years
and over

  • take 2 tablets every 4 to 6 hours while symptoms
    last
  • do not take more than 10 tablets in 24 hours
  • do not take for more than 10 days unless directed by a doctor

children
6-11 years  

  • take 1 tablet every 4 to 6 hours while symptoms
    last
  • do not take more than 5 tablets in 24 hours
  • do not take for more than 5 days unless directed
    by a doctor
children
under 6
years

 ask a doctor


Other information

Inactive ingredients

corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

 1-800-426-9391

Principal display panel

CVS Health™

Compare to the active ingredient in Regular Strength Tylenol®*

Tablets

NDC 59779-104-13

Regular Strength
Pain Relief
ACETAMINOPHEN,
325 mg
Pain reliever/Fever reducer

Aspirin free

250 TABLETS       Actual Size

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Regular Strength Tylenol®.

50844    ORG061510413

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com    1-800-SHOP CVS

Made in the U.S.A with domestic
and imported ingredients.
V-11112

CVS 44-104

CVS 44-104

PAIN RELIEF  REGULAR STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 44;104
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-104-121 in 1 CARTON07/13/199010/19/2017
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59779-104-131 in 1 CARTON07/13/1990
2250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/13/1990
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(59779-104)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(59779-104)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(59779-104)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(59779-104)

Revised: 10/2021
Document Id: 707038be-03fb-4e97-8e7b-0783a582f4eb
Set id: d4e5d776-7deb-4f4f-b6e6-99dee0739323
Version: 11
Effective Time: 20211001
 
CVS Pharmacy