Label: ACETAMINOPHEN tablet, extended release
- NDC Code(s): 37835-512-01
- Packager: Bi-Mart
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 1, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT (IN EACH CAPLET)Acetaminophen 650 mg
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PURPOSEPain reliever/fever reducer
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USES• temporarily relieves minor aches and pains due to: • minor pain of arthritis - • muscular aches - • backache - • premenstrual and menstrual cramps ...
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WARNINGSLiver warning:This product contains acetaminophen. Severe Liver damage may occur if you take - • more than 6 caplets in 24 hours, which is the maximum daily amount - • with other drugs ...
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Do not use• with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are ...
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Ask a doctor before use if you haveliver disease.
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Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
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Stop use and ask 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 ...
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If pregnant or breast-feedingask a health professional before use.
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Keep out of reach of childrenOverdose warning:In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away. Quick medical attention is critical for adults as well as for children even ...
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DIRECTIONS• do not take more than directed (see overdose warning) adults • take 2 caplets every 8 hours with water - • swallow whole; do not crush, chew, split or dissolve - • do ...
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OTHER INFORMATION• store between 20-25°C (68-77°F) • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
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INACTIVE INGREDIENTShydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
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QUESTIONS ?call toll free - 1-844-912-4012
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PRINCIPAL DISPLAY PANELNDC 37835-512-01 - Compare to the active ingredients in Tylenol - ® 8 HR Arthritis Pain* Acetaminophen Extended-release Tablets - 650 mg - Pain reliever/fever reducer - For the Temporary Relief ...
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INGREDIENTS AND APPEARANCEProduct Information