Label: IBUPROFEN tablet
- NDC Code(s): 51316-365-30
- Packager: CVS
- 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
-
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chances is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning(anticoagulant) or steroiddrug
- 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 n take more or for a longer time than directed
- Heart attack and stroke warning:
- Do not use
-
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 n redness or swelling is present in the painful area
- any new symptoms appear
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
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 tablets may be used • do not exceed 6 tablets in 24 hours, unlessdirected by a doctor.
- children under 12 • ask a doctor
- Other Information
- Inactive ingredients
- Questions or comments?
- Principal diaplay panel
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-365 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 POVIDONE K30 (UNII: U725QWY32X) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 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:51316-365-30 300 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 05/25/2024 Labeler - CVS (062312574)