Label: IBUPROFEN 200 MG- ibuprofen capsule, liquid filled
- NDC Code(s): 69168-368-07, 69168-368-30
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 6, 2021
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- Active ingredient(s)
- Purpose
- Use(s)
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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 chances are 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
- 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
- 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
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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 softgel every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 softgel, 2 softgels may be used
- do not exceed 6 softgels in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
IBUPROFEN 200 MG
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-368 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 AMMONIA (UNII: 5138Q19F1X) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN (UNII: 2G86QN327L) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITOL SOLUTION (UNII: 8KW3E207O2) Product Characteristics Color green Score no score Shape CAPSULE Size 15mm Flavor Imprint Code 133 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-368-07 1 in 1 CARTON 12/22/2014 1 10 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-368-30 1 in 1 CARTON 12/22/2014 2 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079205 12/22/2014 Labeler - Allegiant Health (079501930)
