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
Aspiring 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 naussea 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:
Liver warning: This product contains acetaminophen. Severe lliver damage may occur if you take:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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, occasionaly, rapid heartbeat.
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac wax, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
The product packaging shown below representa a sample of that currently in use. Additional packaging may also be available.
CVS®
pharmacy
Compare to the active ingredients
in Excedrin® Extra Strength†
SEE NEW WARNINGS INFORMATION
Extra Strength
HEADACHE RELIEF
COATED TABLETS
ACETAMINOPHEN, ASPIRING (NSAID) AND CAFFEINE
PAIN RELIEVER/PAIN RELIEVER AID
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV0810D15908
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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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC MONOGRAPH NOT FINAL | part343 | 11/17/1992 |
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574) |
Revised: 08/2011 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED