Label: IBUPROFEN SOFTGELS- ibuprofen capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 70729-000-01, 70729-000-02, 70729-509-32 - Packager: Breeden Brothers, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 1, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- 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:
_ blisters
_ rash
_ hives
_ asthma (wheezing)
_ shock
_ skin reddening
_ facial swelling
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 a blood thinning (anticoagulant) or
Drug Facts (continued)
steroid drug
_ are age 60 or older
_ have had stomach ulcers or bleeding problems
_ 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
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 are taking a diuretic
Drug Facts (continued)
_ you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
_ you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
_ taking any other drug
_ under a doctor's care for any serious condition
_ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
When using this product
_ take with food or milk if stomach upset occurs
_ the 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
Drug Facts (continued)
stomach bleeding:
_ feel faint
_ have stomach pain that does not get better
_ have bloody or black stools
_ vomit blood
_ 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 capsule every 4 to 6 hours while symptoms persist
_ if pain or fever does not respond to 1 capsule, 2 capsules may be used
_ do not exceed 6 capsules in 24 hours, unless directed by a doctor
_ children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN SOFTGELS
ibuprofen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70729-000 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 FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color GREEN Score no score Shape CAPSULE Size 18mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70729-000-01 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2018 2 NDC:70729-000-02 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206568 02/01/2018 IBUPROFEN SOFTGELS
ibuprofen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70729-509 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 FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color GREEN Score no score Shape CAPSULE Size 18mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70729-509-32 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206568 02/01/2018 Labeler - Breeden Brothers, LLC (080131046)
