![IBUPROFEN CAPSULE, LIQUID FILLED [THE KROGER CO.]](https://medic.hrt.org//dailymed/images/7ab5f444-2a44-4691-8dc3-ca3dc05a46f0/ibuprofen-200-mg-softgel-ban-delisted-1.jpg)
| NDC | 30142-198-03, 30142-198-16, 30142-198-20, 30142-198-40, 30142-198-80 |
| Set ID | 7ab5f444-2a44-4691-8dc3-ca3dc05a46f0 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | The Kroger Co. |
| 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 an 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 non-prescription 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
- vomit blood
- have bloody or black stools
- have stomach pain that does not bet better
- pain gets worse or last more than 10 days
- fever gets worse or last 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 of ADVIL® LIQUI-GELS® ***See back panel
Ibuprofen
Capsules, 200 mg
Pain Reliever / Fever Reducer (NSAID)
SOFTGELS**
(**LIQUID FILLED CAPSULES)
***Advil® Liqui-Gels® is a registered trademark of Pfizer Consumer Healthcare, New York, NY 10017. Pfizer Consumer Healthcare is not affiliated with The Kroger Co. or this product.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202
- Package Labeling
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-198 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) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color BLUE Score no score Shape OVAL Size 18mm Flavor Imprint Code IB200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-198-40 1 in 1 BOX 07/01/2010 12/30/2021 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:30142-198-20 1 in 1 BOX 07/01/2010 12/30/2021 2 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:30142-198-03 300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2010 12/30/2021 4 NDC:30142-198-16 160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2010 12/30/2021 5 NDC:30142-198-80 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2010 12/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078682 07/01/2010 12/30/2021 Labeler - The Kroger Co. (006999528) Registrant - P & L Development, LLC (079765031)
