![IBUPROFEN CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]](https://medic.hrt.org//dailymed/images/37818b30-48d4-4a4c-a73e-d7a9cac88437/ibuprofen-200-mg-capsule-ban-delisted-1.jpg)
| NDC | 53187-199-20, 53187-199-40, 53187-199-80 |
| Set ID | 37818b30-48d4-4a4c-a73e-d7a9cac88437 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | LIVE BETTER (The Great Atlantic & Pacific Tea Company) |
| 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®
SOFTGELS**
**(LIQUID FILLED CAPSULES)
Ibuprofen
Capsules, 200 mg
- Pain reliever/ fever reducer (NSAID)
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Do not use if tamper-evident seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Liqui-Gels®
Manufactured by:
Banner Pharmacaps
4125 premier drive
High point NC 27265
- Product Label
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53187-199 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:53187-199-80 1 in 1 BOX 03/25/2013 01/26/2024 1 80 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:53187-199-40 1 in 1 BOX 03/25/2013 01/26/2024 2 40 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:53187-199-20 1 in 1 BOX 03/25/2013 01/26/2024 3 20 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 03/25/2013 01/26/2024 Labeler - LIVE BETTER (The Great Atlantic & Pacific Tea Company) (001367366) Registrant - P & L Development, LLC (079765031)
