Label: IBUPROFEN tablet, film coated
- NDC Code(s): 45865-639-30, 45865-639-60
- Packager: Medsource Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0904-7915
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 27, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each brown tablet)
- Purpose
- Uses
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- facial swelling
- hives
- asthma (wheezing)
- rash
- shock
- skin reddening
- blister
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- take more or for a longer time than directed
- are age 60 or older
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- take a blood thinning (anticoagulant) or steroid drug
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
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right before or after heart surgery
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if you have ever had an allergic reaction to any other pain reliever/fever reducer
Ask a doctor before use if you have
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stomach bleeding warning applies to you
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you have a history of stomach problems, such as heartburn
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you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
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you are taking a diuretic
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you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- under a doctor"s care for any serious condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
Stop use and ask a doctor if
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you experience any of the following signs of stomach bleeding:
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have bloody or black stools
- vomit blood
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feel faint
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have stomach pain that does not get better
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you have symptoms of heart problems or stroke
- chest pain
- slurred speech
- leg swelling
- trouble breathing
- weakness in one part or side of body
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pain gets worse or lasts more than 10 days
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fever gets worse or lasts more than 3 days
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redness or swelling is present in the painful area
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any new symptoms appear
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Directions
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do not take more than directed
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the smallest effective dose should be used
- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
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if pain or fever does not respond to 1 tablet, 2 tablets may be used
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do not exceed 6 tablets in 24 hours, unless directed by a doctor
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children under 12 years: ask a doctor
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- Other information
- Inactive ingredients
- Principal Display Panel - 60 count
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45865-639(NDC:0904-7915) 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 HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45865-639-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 2 NDC:45865-639-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/24/1988 Labeler - Medsource Pharmaceuticals (833685915) Establishment Name Address ID/FEI Business Operations Medsource Pharmaceuticals 833685915 repack(45865-639)
