The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg
Pain reliever/fever reducer
- Temporarily relieves minor aches and pains due to:minor pain of arthritis muscular achesbackachepremenstrual and menstrual crampsthe common coldheadache toothachetemporarily reduces fever
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 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 productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.
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 daysfever gets worse or lasts more than 3 days new symptoms occurredness or swelling is presentThese 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: 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.
- Do not take more than directed (see overdose warning).Adults:take 2 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolvedo not take more than 6 tablets in 24 hoursdo not use for more than 10 days unless directed by a doctor.Under 18 years of age:ask a doctor
- Store at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF).do not use if carton is opened or foil inner seal is brokenUSP Dissolution test is pending
Colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetinQuestions or comments? 1-800-632-6900 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 MADE IN INDIA Code: TS/DRUGS/22/2009
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