IBUPROFEN- ibuprofen capsule, liquid filled 
Western Family Foods, Inc.

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DRUG FACTS

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)
*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 and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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

  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn 
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • 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 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 right away.

Directions

Other information

Inactive ingredients

FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Questions or comments?

1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

PAIN RELIEVER/FEVER REDUCER (NSAID)

Ibuprofen

Softgels**

†Compare to the Active Ingredient in Advil® Liqui-Gels®

Ibuprofen Capsules, 200 mg

SOFTGELS **

**(LIQUID FILLED CAPSULES)

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Liqui-Gels®.

Proudly distributed by: Western Family Foods, Inc.

PO Box 4057, Portland, OR 97208

www.westernfamily.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

Product Label

Ibuprofen 200 mg

Western Family Ibuprofen 200 mg Capsule

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55312-197
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
POLYETHYLENE GLYCOLS 
POTASSIUM HYDROXIDE 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code IB200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-197-401 in 1 BOX
140 in 1 BOTTLE
2NDC:55312-197-801 in 1 BOX
280 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868203/13/2010
Labeler - Western Family Foods, Inc. (192166072)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 3/2013
Document Id: bbb997ec-ae9d-4362-a978-cca5bcead33d
Set id: 94bad283-67bb-46dd-b69e-b0734ecf1387
Version: 3
Effective Time: 20130311
 
Western Family Foods, Inc.