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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.
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 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.
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.
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.
Keep out of reach of children
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 caplets every 4 to 6 hours while symptoms last, Do not take more than 8 caplets 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 recommended dose (overdose) of acetaminophen and may cause liver damage.
Hypromellose, Polyollytone Glycol, Providone, Pregelantinized Starch, Sodium Starch Glycolate, Stearlic Acid.
Adverse Drug Event call (800) 616-2471 Dist. By Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA
Revised: 08/2010 NCS HealthCare of KY, Inc dba Vangard Labs
Reproduced with permission of U.S. National Library of Medicine
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