IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated 
Discount Drug Mart

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Ibuprofen tablets USP 200mg
Discount Drug Mart

Drug Facts

ACTIVE INGREDIENT(S)

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


PURPOSE

Pain reliever/fever reducer

USE(S)

WARNINGS

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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:

DO NOT USE

ASK A DOCTOR BEFORE USE IF

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

WHEN USING THIS PRODUCT

STOP USE AND ASK DOCTOR IF


If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofenduring 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 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor

children under 12 years

• ask a doctor

OTHER INFORMATION

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 (Capsule Shaped Tablets) - Principal Display Panel - 50s - Count Carton, 200 mg Tablets

DISCOUNT
drug mart
FOOD FAIR
NDC 53943-403-23
SEE NEW WARNINGS INFORMATION
IBUPROFEN
TABLETS, USP 200 mg
Pain Reliever / Fever Reducer (NSAID)*
IBU
200
50 COATED CAPLETS**
*nonsteroidal anti-inflammatory drug
**capsule-shaped tablets
Compare to the Active Ingredient of ADVIL@***
***This product is not manufactured or distributed by Pfizer Inc. owner of the registered trade mark Advil@

ibuprofen-caplet-carton

IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-403
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWNScoreno score
ShapeCAPSULE (CAPSULE SHAPED) Size10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-403-231 in 1 CARTON
150 in 1 BOTTLE
2NDC:53943-403-241 in 1 CARTON
2100 in 1 BOTTLE
3NDC:53943-403-29500 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912912/22/2014
Labeler - Discount Drug Mart (047741335)
Registrant - Shasun Pharmaceuticals Limited (915786829)
Establishment
NameAddressID/FEIBusiness Operations
Shasun Pharmaceuticals Limited915786829MANUFACTURE(53943-403)

Revised: 11/2014
Document Id: baf329a1-cef9-445e-8a16-26976e22f4cc
Set id: baf329a1-cef9-445e-8a16-26976e22f4cc
Version: 1
Effective Time: 20141118
 
Discount Drug Mart