ACETAMINOPHEN EXTRA STRENGTH- acetaminophen 
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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Pain Reliever

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • skin reddening
  • blisters
  • rash

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

Do not use

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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.

In case of accidental overdose, get medical help or contact a Poison Control Center 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

  • do not take more than directed
  • adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

♥︎CVSHealth™

Compare to the active ingredient in
Extra Strength Tylenol® Caplets*

Caplets

EXTRA STRENGTH
Acetaminophen
Caplets 500 mg 
Pain reliever, Fever reducer

50 COATED CAPLETS +
10
 CT TRAVEL VIAL

Actual Size

Actual Bottle
Size on Top Panel

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

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Extra Strength Tylenol® Caplets.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2020 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

V-11112

CVS® Quality
Money Back Guarantee

50844    REV0617A17511

44-175

44-175

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-759
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-759-111 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product01/28/202006/11/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 50 
Part 21 BOTTLE, PLASTIC 10 
Part 1 of 2
ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;175
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
150 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 finalpart34301/28/2020
Part 2 of 2
ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;175
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 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 finalpart34301/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/28/202006/11/2023
Labeler - CVS PHARMACY (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(69842-759)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(69842-759) , pack(69842-759)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(69842-759)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(69842-759)

Revised: 4/2022
 
CVS PHARMACY