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IBUPROFEN IMMEDIATE RELEASE by Discount Drug Mart

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Discount Drug Mart
NDC Code: 53943-403

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)
  • 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 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

  • 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 (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  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-403
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, PREGELATINIZED CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSE 2910 (6 MPA.S) 
TITANIUM DIOXIDE 
TRIACETIN 
TALC 
FERRIC OXIDE RED 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULE (CAPSULE SHAPED) Size10mm
FlavorImprint CodeIBU200
Contains    
Packaging
#Item CodePackage Description
1NDC:53943-403-231 BOTTLE in 1 CARTON
150 TABLET, COATED in 1 BOTTLE
2NDC:53943-403-241 BOTTLE in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE
3NDC:53943-403-29500 TABLET, COATED 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/FEIOperations
Shasun Pharmaceuticals Limited915786829MANUFACTURE(53943-403)

Revised: 11/2014
 
Discount Drug Mart

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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