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Pain Reliever Extra Strength by CVS Pharmacy

Medically reviewed on February 14, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: CVS Pharmacy
NDC Code: 59779-101

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 44-148

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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
  • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

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 Extra Strength Tylenol®*

Tablets
NDC 59779-101-12

EXTRA STRENGTH
Pain Relief
ACETAMINOPHEN,
500 mg
Pain reliever, Fever reducer
Aspirin free

100 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®.

50844  ORG061514812

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

V-11112

CVS® Quality
Money Back Guarantee

CVS 44-148

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STEARIC ACID 
STARCH, CORN 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code44;148
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-101-121 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
2NDC:59779-101-111 BOTTLE in 1 CARTON
260 TABLET in 1 BOTTLE
3NDC:59779-101-0310 TABLET in 1 VIAL, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/21/1993
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-101)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-101)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(59779-101)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(59779-101)

 
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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