IBUPROFEN- ibuprofen tablet 
Western Family Foods, Inc.

----------

DRUG FACTS

Active Ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever/ Fever Reducer

Uses

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 an seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause severe stomach bleeding. The chance are higher if you:

Do not use

  • if you 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 aspirin to prevent 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 a 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 bet better
    • Pain gets worse or last more than 10 days
    • Fever gets worse or last 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 druing the last 3 months of pegnancy unless defintely 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
 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 20o- 25o C (68o- 77o F)
  • read all warnings and directions before use. Keep carton
  • do not use if imprinted foil under cap is broken or missing
  • †This product is not manufactured or distributed by Pfizer consumer healthcare, owner of the registered trademark Advil®

Inactive Ingredients

colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin

Questions or comments?

Call: 1-503-639-6300 Monday- Friday 9AM-5PM PST

Principal Display Panel

Compare to the active ingredient in ADVIL®†

SEE NEW WARNINGS INFORMATION

Ibuprofen Tablets

Pain Reliever/ Fever Reducer (NSAID)*

Proudly distributed by Western family foods, Inc.

PO Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Manufactured by:

Granules India limited

Madhapur, Hyderabad- 500081, India

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

western family Ibuprofen tablets 200 mg granules

Ibuprofen tablets 200 mg tablets

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-218
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorBROWN (reddish) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-218-101 in 1 BOX
1100 in 1 BOTTLE
2NDC:55312-218-241 in 1 BOX
224 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917407/05/2012
Labeler - Western Family Foods, Inc. (192166072)

Revised: 10/2012
Document Id: 7ddacf90-6468-4342-837c-fe4330f5a7ea
Set id: 523bef75-c20a-4cfd-8d31-725bafae6df8
Version: 2
Effective Time: 20121009
 
Western Family Foods, Inc.