Label: IBUPROFEN tablet, film coated
- NDC Code(s): 70729-291-12
- Packager: Breeden Brothers, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 6, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each brown tablet)
- Purpose
- Uses
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Warnings
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See carton for complete warnings (short label only)
See vial card for complete warnings (vial label only)
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters
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 74 words
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 directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, 37 words
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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• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
Ask a doctor before use if
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• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• 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 diureticAsk a doctor or pharmacist before use if you are
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• 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:
• 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
- you experience any of the following signs of stomach bleeding:
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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
• 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
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do not take more than directed
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Other information
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TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING (short label only)
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TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN (blister package only)
- store between 20˚-25˚C (68˚-77˚F)
- avoid excessive heat 40˚C (104˚F)
- see end flap for expiration date and lot number (carton only)
- use by expiration date on package (vial card, vial label & label only)
- 63 words
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70729-291 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) 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:70729-291-12 1 in 1 CARTON 05/24/1988 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 05/24/1988 Labeler - Breeden Brothers, LLC (080131046)
