Label: ACETAMINOPHEN tablet
- NDC Code(s): 69848-003-10, 69848-003-17, 69848-003-24
- Packager: Granules USA, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 16, 2024
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 ingredient(in each Caplet) Acetaminophen, USP 500 mg
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PurposePain 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 - ■ toothache ■ muscular aches ...
- Warnings
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Liver warningThis 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 alcoholic ...
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Allergy alertacetaminophen 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 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 ...
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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 aretaking the blood thinning drug warfarin
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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.
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If pregnant or breast-feedingask a health professional before use.
- Keep out of the reach of children.
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Overdose warningIn case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Promt medical attention is critical for adults as well as for children even if you do not ...
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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 between 20-25°C (68-77°F).See USP Controlled Room Temperature - ■ avoid high humidity - ■ see end panel for lot number and expiration date
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Inactive ingredientshydroxypropyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
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Questions or comments?call - 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
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PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCEProduct Information