Label: IBUPROFEN tablet
- NDC Code(s): 0363-9593-21
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 5, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each captet)
- Purposes
- Uses
- Allergy alert:
-
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 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
-
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 than10 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.
-
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and older
- take 1 captet every 4 to 6 hours while symptoms persist • If pain or fever does not respond to 1 captet, 2 captets may be used • do not exceed 6 captets in 24 hours, unless directed by a doctor.
- children under 12 years
- ask a doctor
- Other Information
- Inactive ingredients
- Questions or comments?
- Principal display panel
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9593 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color orange Score no score Shape OVAL Size 14mm Flavor Imprint Code G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9593-21 225 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202312 05/01/2024 Labeler - Walgreens (008965063)