Label: IBUPROFEN tablet
- NDC Code(s): 0536-1390-47, 0536-1390-48
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 18, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purposes
- Uses
- Warnings
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Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older
■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed - Heart attack and stroke warning:
- Do not use
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Ask a doctor before use if
■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke ■ you are taking a diuretic - Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop use and ask a doctor if
■ you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools
• have stomach pain that does not get better ■ you have symptoms of heart problems or stroke: • chest pain • trouble breathing• weakness in one part or side of body • slurred speech • leg swelling ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present in the painful area ■ any new symptoms appear
- If pregnant or breast-feeding,
- Keep out of reach of children.
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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 tablet
every 4 to 6 hours while symptoms persist • if pain or fever does not respond to 1 tablet, 2 tabletsmay be used • do not exceed 6 tablets in 24 hours, unless directed by a doctor ■ children under 12 years: • ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- PDP
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1390 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FERRIC OXIDE RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color red ((Reddish Brown)) Score no score Shape ROUND Size 10mm Flavor Imprint Code G;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1390-48 100 in 1 CARTON; Type 0: Not a Combination Product 12/31/2024 2 NDC:0536-1390-47 2 in 1 PACKET; Type 0: Not a Combination Product 08/25/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 08/25/2023 Labeler - Rugby Laboratories (079246066)