![IBUPROFEN CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]](https://medic.hrt.org//dailymed/images/5bdb4a9d-540d-4294-9487-72cbfe72d1ab/ibuprofen-200-mg-orange-softgel-ban-delisted-1.jpg)
- 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:
- 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
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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?
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Principal Display Panel
Liquid Softgels**
Ibuprofen
Capsules, 200 mg
Pain reliever
Fever reducer (NSAID)
Compare to Motrin® active ingredient†
Softgels**
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 manufctured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Motrin®
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
- Product Label
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-048 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) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color ORANGE 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:36800-048-40 1 in 1 BOX 05/31/2015 12/31/2021 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:36800-048-20 1 in 1 BOX 05/31/2015 12/31/2021 2 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078682 05/31/2015 12/31/2021 Labeler - TOP CARE (Topco Associates LLC) (006935977)
