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Acetaminophen Extra Strength by CVS Pharmacy

Medically reviewed on October 13, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: CVS Pharmacy
NDC Code: 69842-531

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.

CVS 44-531

Active ingredients

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • toothache
    • headache
    • the common cold
    • backache
    • muscular aches
    • minor pain of arthritis
    • 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 in 24 hours, which is the maximum daily amount
  • 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:

  • blisters
  • rash
  • skin reddening

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 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 (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
  • do not take more than directed
  • adults and children 12 years and over
  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets 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)
  • use by expiration date on package

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

CVS
Health

Compare to the active ingredient
in Extra Strength Tylenol® *

Easy to Swallow Tablets

NDC 69842-531-29

EXTRA STRENGTH
Acetaminophen

Tablets, 500 mg

Pain reliever, Fever reducer

Aspirin free
Sweet coating

150 FILM COATED
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 Extra Strength Tylenol®.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy CVS.com®
1-800-SHOP CVS V-11112

CVS® Quality
Money Back Guarantee

50844        ORG081653129

CVS 44-531

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-531
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;531
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-531-29150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/11/2005
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(69842-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(69842-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(69842-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(69842-531)

 
CVS Pharmacy

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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