IBUPROFEN- ibuprofen capsule, liquid filled 
Shopko Stores Operating Co., LLC.

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DRUG FACTS

Active ingredient

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

  • 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
    • have bloody or black stools
    • vomit blood
    • 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?

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

 †COMPARE TO THE ACTIVE INGREDIENT IN ADVIL® LIQUI-GELS®

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)*

Gluten Free

Softgels**

(**Liquid Filled Capsules)

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

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.

Packaged by: PL Developments

200 Hicks Street

Westbury, NY  11590, USA

©2012 Shopko Stores

Operating Co., LLC

Package Label

 Ibuprofen, 200 mg

Shopko Ibuprofen Capsules, 200 mg

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-199
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code IB200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-199-801 in 1 CARTON
180 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868207/09/2010
Labeler - Shopko Stores Operating Co., LLC. (023252638)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 5b630b51-cb5c-4f12-ad57-c54bd8d4b30f
Set id: 035db1ab-0c4d-4465-a71d-5e9cf228aa1a
Version: 1
Effective Time: 20121217
 
Shopko Stores Operating Co., LLC.