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Headache Relief Extra Strength

Medically reviewed on April 13, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, CAFFEINE 65mg
Labeler: CVS Pharmacy
NDC Code: 59779-571

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 44-571

Active ingredients (in each gelcap)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Pain reliever aid 

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • arthritis
    • a cold
    • muscular aches
    • toothache
    • premenstrual and menstrual cramps 

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. 

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

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.

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

  • with other drugs containing acetaminophen
  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning:  This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use
  • if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
  • 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
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have liver disease
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • you are taking a diuretic 

Ask a doctor or pharmacist before use if you are
  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug or are under a doctor's care for any serious condition 

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • painful area is red or swollen 

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 

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 use more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over
    • take 2 gelcaps every 6 hours
    • do not take more than 8 gelcaps in 24 hours
  • children under 12 years: ask a doctor 

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, D&C yellow #10, FD&C blue #1, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, simethicone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide 

Questions or comments?

1-800-426-9391

Principal display panel

♥︎CVS Health™

Compare to the active ingredients in Excedrin® Extra Strength

Rapid Release Gelcaps

NDC 59779-571-09

EXTRA STRENGTH                           RAPID RELEASE

Headache Relief
ACETAMINOPHEN, ASPIRIN (NSAID)
& CAFFEINE

Pain reliever,
Pain reliever aid

20 GELCAPS

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 Novartis AG, Inc., owner of the registered trademark
Excedrin® Extra Strength.

50844   REV0117B57109

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2017 CVS/pharmacy
CVS.com®   1-800-SHOP CVS
V-11112

CVS®Quality 
Money Back Guarantee

CVS 44-571

HEADACHE RELIEF  EXTRA STRENGTH
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-571
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
TITANIUM DIOXIDE 
STARCH, CORN 
MICROCRYSTALLINE CELLULOSE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
GELATIN 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize20mm
FlavorImprint CodeL;1
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-571-311 BOTTLE in 1 CARTON
180 TABLET in 1 BOTTLE
2NDC:59779-571-121 BOTTLE in 1 CARTON
2100 TABLET in 1 BOTTLE
3NDC:59779-571-091 BOTTLE in 1 CARTON
320 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/09/2009
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-571)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-571)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(59779-571)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(59779-571)

 
CVS Pharmacy

← See all Headache Relief Extra Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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