IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by Discount Drug Mart, Shasun Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(in each brown tablet)
Ibuprofen USP 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USE(S)

• 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 an nonsteroidal anti-inflammatory drug (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

• 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

• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• 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
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed 

STOP USE AND ASK 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

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 (1-800-222-1222) right away.

DIRECTIONS

do not take more than directed
the smallest effective dose should be used   

• 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)
• tamper evident: do not use if imprinted safety seal under cap is broken or missing
• see end panel for lot number and expiry date

INACTIVE INGREDIENT (S)

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide, triacetin and talc

QUESTIONS OR COMMENTS?
Adverse drug event Call: (877) 586-7979

PRINCIPAL DISPLAY PANEL

Package Label (Round Shaped Tablets) - Principal Display Panel - 50s - Count Carton, 200 mg Tablets

DISCOUNT
drug mart
FOOD FAIR
NDC: 53943-401-09
SEE NEW WARNINGS INFORMATION
IBUPROFEN
TABLETS, USP 200 mg
Pain Reliever / Fever Reducer (NSAID)*
IBU
200
50 COATED TABLETS
*nonsteroidal anti-inflammatory drug
Compare to the Active Ingredient of ADVIL@**
**This product is not manufactured or distributed by Pfizer Inc. owner of the registered trade mark Advil@

INGREDIENTS AND APPEARANCE

IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-401
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
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND (ROUND SHAPED)	Size	10mm
Flavor		Imprint Code	IBU200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53943-401-09	1 in 1 CARTON
1		50 in 1 BOTTLE
2	NDC: 53943-401-10	1 in 1 CARTON
2		100 in 1 BOTTLE
3	NDC: 53943-401-15	500 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079129	12/22/2014

Labeler - Discount Drug Mart (047741335)

Registrant - Shasun Pharmaceuticals Limited (915786829)

Establishment
Name	Address	ID/FEI	Business Operations
Shasun Pharmaceuticals Limited		915786829	MANUFACTURE(53943-401)