IBUPROFEN - ibuprofen capsule, liquid filled 
Fred's Inc.

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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

Uses

Warnings

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 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 PoisonControlCenter right away.

Directions

Other Information

Other information

Inactive Ingredients

FDandC Blue 1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, and sorbitol

Questions or comments?

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

Product Labeling


NDC: 55315-122-80
Important: Read all product information before using



IBUPROFEN Liquid Softgels, 200mg

Pain Reliever/Fever Reducer (NSAID)
80 softgels (liquid filled capsules)

compare to the active ingredient in Advil Liquigels

Product Container Label

Ibuprofen

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-122
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 
Product Characteristics
Colorblue (blue) Scoreno score
ShapeOVAL (oval) Size10mm
FlavorImprint Code IB200
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-122-801 in 1 BOX
180 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868204/09/2012
Labeler - Fred's Inc. (005866116)

Revised: 11/2012
Document Id: afc02e22-6f58-42dd-8202-b51e48061ea5
Set id: 9e908e82-649f-42b2-a95f-0710460c2c6c
Version: 2
Effective Time: 20121119
 
Fred's Inc.