Label: DRAGON TABS- ibuprofen 200 mg tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50066-374-40 - Packager: Genomma Lab USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 17, 2015
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- Active ingredient
- Purpose
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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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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 surgeryAsk a doctor before use if
■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the stomach bleeding warning applies to you■ you have a history of stomach problems, such as heartburn ■ you
have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you have asthma ■ you are taking a diureticAsk a doctor or pharmacist before use if
you are taking any other drug containing an NSAID (prescription or nonprescription) taking a
blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition
taking any other drugWhen using this product
take with food or milk if stomach upset occurs
long term continuous use may increase the risk of heart attack or strokeStop use and ask a doctor if
you faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear
- Keep Out of Reach of Children
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Directions
■ do not take more than directed
■ the smallest effective dose should be used
■ do not take longer than 10 days, unless directed by a doctor (see Warnings)
Adults and children 12 years and older: ■ take 1 tablet every 4 to 6 hours while symptoms persist
■ if pain or fever does not respond to 1 tablet, 2 tablets may be used ■ do not exceed 6 tablets in
24 hours unless directed by a doctor
Children under 12 years:ask a doctor - Other information
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
DRAGON TABS
ibuprofen 200 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-374 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LACTOSE (UNII: J2B2A4N98G) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code 44291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-374-40 40 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 04/17/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 04/17/2015 Labeler - Genomma Lab USA (832323534) Registrant - Genomma Lab USA (832323534)
