Label: ACETAMINOPHEN 500 MG- acetaminophen tablet
- NDC Code(s): 84324-021-01
- Packager: NUVICARE LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 25, 2024
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONDrug Facts
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Active ingredient (in each caplet)
Acetaminophen 500 mg
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Purpose
Pain reliever/fever reducer
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Uses
temporarily relieves minor aches and pains due to: the common cold - headache - backache - minor pain of arthritis - muscular aches - toothache - premenstrual and menstrual cramps - temporarily reduces ...
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen - 3 or more ...
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OTHER SAFETY INFORMATIONAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening - blisters - rash - If a skin reaction occurs, stop use and seek medical help right away.
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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 have - liver disease
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ASK DOCTOR/PHARMACISTAsk a doctor/pharmacist before use if you are - taking the blood thinning drug warfarin
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STOP USEStop use and ask a doctor if - pain gets worse or lasts more than 10 days - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as ...
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Directions
do not take more than directed (see overdose warning) Adults and children 12 years and over: take 2 Caplets every 6 hours while symptoms last - do not take more than 6 caplets in 24 hours ...
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Other information
store at 20º - 25ºC (68º -77ºF)
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Inactive ingredients
Pregelatinzed starch, Polyvinyl pyrrolidone, stearic acid powder, microcrystalline cellulose, magnesium stearate, Hypromellose-5, Hypromellose-15, polyethlene glycol 400, titanium dioxide ...
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Questions or comments?
Call 1 (718) 337-8733 or visit: support@nuvicare.com
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SPL UNCLASSIFIED SECTIONThis product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tyleno® Extra Strength Caplets.
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PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCEProduct Information