Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
for the temporary relief of minor aches and pains due to: Headache, Muscular aches, Backache, Minor pain of arthritis, The common cold, Toothache, Premenstrual and menstrual cramps.
Temporarily reduces fever.
This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount, or with other drugs containing acetaminophen, or 3 or more alcoholic drinks every day while using this product.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If you are allergic to acetaminophen or any of the inactive ingredients in this product.
Pain gets worse or lasts more than 10 days.
Fever gets worse or lasts more than 3 days.
New symptoms occur.
Redness or swelling is present.
These could be signs of a serious condition.
Overdose Warning: Taking more than the recommended dose ( overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not take more than directed.
Adults and Children 12 years and over: Take 2 tablets every 4 to 6 hours while symptoms last.
Do not take more than 8 tablets in 24 hours.
Do not take for more than 10 days unless directed by a doctor.
Children under 12 years: Do not use adult Extra Strength product in children under 12 years of age: this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
Adverse Drug Event call (800) 616-2471.
Dist. By Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA
Compare to the active ingredient in Extra Strength Tylenol® Tablets*
*This product is not manufactured or distributed by McNeil Consumer Products Co.,
owner of the registered trademark Tylenol®.
500 mg. EACH
See New Warnings Information
Zanesville, OH 43701
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|Unapproved drug other||05/31/2011|
|Labeler - Cardinal Health (188557102)|
Revised: 05/2011 Cardinal Health