Label: IBUPROFEN FAST RELIEF MEDICINE FOR PAIN- ibuprofen 200 mg tablet
- NDC Code(s): 69168-335-01, 69168-335-03, 69168-335-30, 69168-335-40
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 17, 2017
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- Official Label (Printer Friendly)
- Active ingredient (in each 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:
- 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 a nonsteroidal anti-inflammatory drug (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. 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
■ 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, or kidney disease ■ you have asthma ■ you are taking a diureticAsk a doctor or pharmacist before use if you are
■ taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor’s care for any serious condition ■ taking any other drug
When using this product
take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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 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 appearAsk a doctor before use if
- 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 diuretic
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
- 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 reach of children.
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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
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
IBUPROFEN FAST RELIEF MEDICINE FOR PAIN
ibuprofen 200 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-335 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 STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code IBU200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-335-01 100 in 1 BOX; Type 0: Not a Combination Product 12/19/2014 2 NDC:69168-335-03 250 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2014 3 NDC:69168-335-30 30 in 1 BOX; Type 0: Not a Combination Product 12/19/2014 4 NDC:69168-335-40 40 in 1 BOX; Type 0: Not a Combination Product 12/19/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079129 12/19/2014 Labeler - Allegiant Health (079501930) Establishment Name Address ID/FEI Business Operations Strides Shasun Limited 871402375 ANALYSIS(69168-335) , MANUFACTURE(69168-335)
