Ibuprofen softgels 200 mg

IBUPROFEN - ibuprofen capsule, liquid filled 
P and L Development of New York Corporation

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Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200mg 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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

FDC Blue no.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

image of ibu carton

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IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-121(NDC:10888-7133)
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 
SORBITAN 
SORBITOL 
Product Characteristics
ColorBLUEScore no score
ShapeCAPSULESize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:59726-121-4040 CAPSULE, LIQUID FILLED (40 CAPSULE) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868208/30/201112/28/2012

Labeler - P and L Development of New York Corporation (800014821)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 05/2012 P and L Development of New York Corporation