Label: IBUPROFEN tablet, coated
- NDC Code(s): 36800-286-03
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 23, 2022
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONDrug Facts
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Active ingredient (in each tablet)Ibuprofen 200 mg (NSAID)* * nonsteroidal anti-inflammatory drug
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PurposesPain reliever/fever reducer
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Usestemporarily relieves minor aches and pains due to: headache - muscular aches - minor pain of arthritis - toothache - backache - the common cold - menstrual cramps - temporarily reduces ...
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WarningsAllergy alert - Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives - facial swelling - asthma (wheezing) shock - skin ...
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Directions■ do not take more than directed - ■ the smallest effective dose should be used - ■ adults and children 12 years and over: ■ take 1 tablet every 4 to 6 hours while ...
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Other informationread all warnings and directions before use - store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) retain carton for complete product information and ...
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Inactive ingredientscolloidal silicon dioxide, corn starch, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
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PRINCIPAL DISPLAY PANELTopCare® Health - COMPARE TO MOTRIN® IB ACTIVE INGREDIENT† NDC 36800-286-03 - Ibuprofen - Tablets, 200 mg - PAIN RELIEVER • FEVER REDUCER (NSAID) 100 COATED TABLETS - actual size
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INGREDIENTS AND APPEARANCEProduct Information