Extra Strength Headache Relief

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-571

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each gelcap)
• Purpose
• Extra Strength Headache Relief Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Extra Strength Headache Relief Other information
• Inactive ingredients
• Questions or comments?
• Principal display panel

FULL PRESCRIBING INFORMATION

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 

Extra Strength Headache Relief Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • a cold
  • arthritis
  • sinusitis
  • toothache
  • muscular aches
  • 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.  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)

Liver 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
• have 3 or more alcoholic drinks every day while using this product
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• 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, occassionally, rapid heartbeat.

Do not use

• if you ever had an allergic reaction to 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

• you have liver disease
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• 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 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick 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: do not use unless directed by a doctor 

Extra Strength Headache Relief Other information

• store at controlled room temperature 15º-30ºC (59º-86ºF)
• 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, microcyrstalline cellulose, polyethylene glycol, povidone, pregelatinized starch, 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®
pharmacy

†Compare to the active ingredients in Excedrin® Extra Strength Express Gels™

Extra Strength
HEADACHE RELIEF
RAPID RELEASE GELCAPS
ACETAMINOPHEN,
ASPIRIN (NSAID) AND CAFFEINE
Pain reliever/
Pain reliever aid

FAST RELEASE GELS
20 GELCAPS

†This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Excedrin® Extra Strength Express Gels.

50844    REV0312C57109

Distributed by: CVS/pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2012 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

V-11112

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