Label: ACETAMINOPHEN- acetaminophen tablet extended release tablet, extended release
- NDC Code(s): 76420-914-01, 76420-914-05, 76420-914-26, 76420-914-40, view more
- Packager: Asclemed USA, Inc.
- This is a repackaged label.
- Source NDC Code(s): 49483-699
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 24, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENTActive ingredient (in each caplet) Acetaminophen 650 mg
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PURPOSEPurpose - Pain reliever/fever reducer
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INDICATIONS & USAGEUses - For Arthritis Pain - temporarily relieves minor aches and pains due to: minor pain of arthritis - muscular aches - backache - premenstrual and menstrual cramps - the common ...
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WARNINGSWarnings - Liver 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 USEDo 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 ...
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ASK DOCTORAsk a doctor before use if you haveliver disease.
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ASK DOCTOR/PHARMACISTAsk a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.
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STOP USEStop using 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 ...
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PREGNANCY OR BREAST FEEDINGIf pregnant or breast-feeding,ask a health professional before use.
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KEEP OUT OF REACH OF CHILDRENKeep 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 ...
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DOSAGE & ADMINISTRATIONDirections - For Arthritis Pain - 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 ...
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STORAGE AND HANDLINGOther information - store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP
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INACTIVE INGREDIENTInactive ingredientscarnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide ...
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OTHER SAFETY INFORMATIONQuestions or comments? Call - 1-877-290-4008
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELRelabeled and Repackaged by: Enovachem PHARMACEUTICALS - Torrance, CA 90501
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INGREDIENTS AND APPEARANCEProduct Information