Label: IBUPROFEN capsule, liquid filled
- NDC Code(s): 53345-014-02
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 22, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- blister
Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take 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
- 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 conditon
- 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 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 commonts
- PRINCIPAL DISPLAY PANEL - Shipper Label
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-014 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 GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN (UNII: 2G86QN327L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color green (Clear) Score no score Shape CAPSULE (Oblong) Size 18mm Flavor Imprint Code PC16 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-014-02 35 in 1 BOX 07/13/2017 1 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 ANDA206568 07/13/2017 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 manufacture(53345-014) , analysis(53345-014)
