Label: DYE FREE IBUPROFEN- ibuprofen tablet
- NDC Code(s): 70729-002-24, 70729-002-50
- Packager: Breeden Brothers, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 15, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each white tablet)
- Purpose
- Uses
-
Warnings
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 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: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.
Drug Facts (continued)
These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
_ 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
_ 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
_ 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 any other drug
Drug Facts (continued)
_ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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 _ slurred speech
_ leg swelling _ trouble breathing
_ weakness in one part or side of body
_ pain gets worse or lasts more than 10 days
_ fever gets worse or lasts more than 3 days
_ any new symptoms appear
_ redness or swelling is present in the painful area
Drug Facts (continued)
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Directions
_ do not take more than directed
_ 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
Drug Facts (continued)
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DYE FREE IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70729-002 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TRIACETIN (UNII: XHX3C3X673) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;438 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70729-002-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/1999 2 NDC:70729-002-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075139 03/01/1999 Labeler - Breeden Brothers, LLC (080131046)
