Label: IBUPROFEN tablet, film coated
- NDC Code(s): 0904-7912-24, 0904-7912-51, 0904-7912-59
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 6, 2024
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- Official Label (Printer Friendly)
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Active ingredient (in each caplet)Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
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PurposesPain reliever/fever reducer
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Uses• temporarily 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 older: • take 1 caplet every 4 to 6 hours while symptoms persist - • if pain ...
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Other information• read all warnings and directions before use • store between 20-25°C (68-77°F) • avoid high humidity and excessive heat above 40°C (104°F) • see end panel for lot number and expiration ...
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Inactive ingredientscolloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid ...
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Questions or comments? 1-800-616-2471
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Principal Display PanelMAJOR® SEE REVISED WARNING - Ibuprofen Tablets, 200mg - PAIN RELIEVER / FEVER REDUCER (NSAID) COMPARE TO the active ingredient of ADVIL® 50 COATED CAPLETS** ** Capsule-Shaped Tablets - Actual ...
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INGREDIENTS AND APPEARANCEProduct Information