![IBUPROFEN CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]](https://medic.hrt.org//dailymed/images/31222a9b-cb10-4e66-a705-28e59f3036b7/ibuprofen-200-mg-capsules-banner-1.jpg)
| NDC | 63868-759-40, 63868-759-48, 63868-759-80 |
| Set ID | 31222a9b-cb10-4e66-a705-28e59f3036b7 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | QUALITY CHOICE (Chain Drug Marketing Association) |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA078682 |
- Active ingredient (in each capsule)
- 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
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
- the 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 or asthma
- 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
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 stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- 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 appear
-
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
†Compare to the active ingredient in Advil® Liqui-Gels®
Ibuprofen
Pain Reliever | Fever Reducer (NSAID)
Capsules, 200 mg
Softgels**
(**Liquid Filled Capsules)
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Liqui-Gels®.
Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.
- Product Label
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-759 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 BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 19mm Flavor Imprint Code IB200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-759-80 1 in 1 BOX 03/11/2013 1 80 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63868-759-48 1 in 1 BOX 03/11/2013 2 48 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:63868-759-40 1 in 1 BOX 03/11/2013 3 40 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 ANDA078682 03/11/2013 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
