![IBUPROFEN CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 70000]](https://medic.hrt.org//dailymed/images/e5b2fa58-704c-4745-aa9a-0bc76a369ce4/ibuprofen-200mg-softgels-pur-1.jpg)
| NDC | 70000-0360-1, 70000-0360-2, 70000-0360-3 |
| Set ID | e5b2fa58-704c-4745-aa9a-0bc76a369ce4 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Cardinal Health (Leader) 70000 |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA206568 |
- 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
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
- 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, asthma, or had a stroke
- 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
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
- you have symptoms of heart problems or stroke:
- chest pain
- slurred speech
- trouble breathing
- leg swelling
- weakness in one part or side of body
- 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
COMPARE TO ADVIL® LIQUI-GELS® active ingredient†
Ibuprofen
Solubilized Capsules, 200 mg
Pain Reliever / Fever Reducer
SOFTGELS**
(**Liquid Filled Capsules)
TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
**This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® Liquid Gels®.
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
- Product Label
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0360 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 GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Product Characteristics Color green Score no score Shape CAPSULE Size 19mm Flavor Imprint Code PC16 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0360-2 1 in 1 BOX 02/28/2018 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:70000-0360-1 1 in 1 BOX 02/28/2018 2 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:70000-0360-3 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206568 02/28/2018 Labeler - Cardinal Health (Leader) 70000 (063997360)
