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.
ACTIVE INGREDIENT (IN EACH TABLET)
Acetaminophen Tablets, 325mg
Pain reliever/fever reducer
temporarily reduces fever
temporarily relieves minor aches and pains due to:
the common cold
minor pain of arthritis
premenstrual and menstrual cramps
Liver warning: 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
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Do not use
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
Ask a doctor before use if you
have liver disease
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In 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.
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
do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
store at 15° to 30°C (59° to 86°F)
povidone, pregelatinized starch, stearic acid
QUESTIONS OR COMMENTS?
Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.
call toll free 734-743-6000
Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA