EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin and caffeine tablet, film coated
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
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.
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Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
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)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 8 caplets 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
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.
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.
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
taking a prescription drug for diabetes, gout, or arthritis
taking any other drug or are under a doctor’s care for any serious condition
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
do not use more than directed
drink a full glass of water with each dose
adults and children 12 years and over
take 2 caplets every 6 hours
do not take more than 8 caplets in 24 hours
children under 12 years: do not use unless directed by a docto
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac wax, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
CVS®
pharmacy
Compare to the active
ingredients in Excedrin®
SEE NEW WARNINGS INFORMATION
Extra Strength
HEADACHE RELIEF
COATED CAPLETS
ACETAMINOPHEN, ASPIRIN (NSAID)
AND CAFFEINE
PAIN RELIEVER
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 ORG081033417
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2011 CVS/pharmacy
Product Packaging
EXTRA STRENGTH HEADACHE RELIEF
acetaminophen, aspirin and caffeine tablet, film coated |
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Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574) |