Label: IBUPROFEN tablet
- NDC Code(s): 0363-9594-07, 0363-9594-10
- Packager: WALGREENS CO.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 16, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Allery Alert
-
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
-
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 the reach of children.
-
Directions
■ do not take more than directed
■ the smallest effective dose should be usedAdults 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, unless directed by a doctor
Children under 12 years
■ ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Ibuprofen Tablets 200 mg 100 ct
- PDP
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9594 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 FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE K30 (UNII: U725QWY32X) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color brown ((Reddish Brown color Tablets)) Score score with uneven pieces Shape ROUND Size 10mm Flavor Imprint Code G;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9594-10 100 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 10/15/2021 2 NDC:0363-9594-07 15 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 10/15/2021 Labeler - WALGREENS CO. (008965063)