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
- 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
![Extra Strength Headache Relief Extra Strength Headache Relief](/upfiles/mm/415/extra-strength-headache-relief-1_deecc4ee.jpg)
Extra Strength Headache ReliefAcetaminophen, Aspirin, Caffeine CAPSULE, GELATIN COATED
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