DRAGON TABS- ibuprofen 200 mg tablet

Dragon by

Drug Labeling and Warnings

Dragon by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ibuprofen USP, 200mg (NSAID)**
**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever

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 surgery

Ask 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 diuretic

Ask 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 drug

When using this product

take with food or milk if stomach upset occurs
long term continuous use may increase the risk of heart attack or stroke

Stop 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

If pregnant or breast-feeding

ask a health professional before use.  It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

store between 20-25 °C (68-77° F).■ Read all warnings and directions before useDo not use if
seal under bottle cap is broken or missing.

Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate, titanium dioxide, carnuba wax, lactose, polydextrose, polyethylene glycol

Questions or Comments?

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST.

Package/Label Principal Display Panel

Dragon Tabs
Ibuprofen 200 mg/Ibuprofeno 200mg
Pain Reliever/Fever Reducer (NSAID)
Alivia el Dolor/Reduce la fiebre (AINE)

Temporarily Relieves:
Backache
Muscular aches

Alivio Temporal de:
Dolor de Espalda
Dolores Musculares

40 Tablets/Tabletas

INGREDIENTS AND APPEARANCE

DRAGON  TABS
ibuprofen 200 mg tablet

Product 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)