POLYETHYLENE GLYCOL 3350 - polyethylene glycol 3350 powder, for solution 
Emcure Pharmaceuticals USA Inc.

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Drug Facts
Active ingredient (in each dose)
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
Osmotic Laxative

INDICATIONS & USAGE

Use

WARNINGS

Allergy alert:

Do not use if you are allergic to polyethylene glycol


Do not use if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have
Ask a doctor of pharmacist before use if you are taking a prescription drug

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

 

Other information

Inactive ingredients               none

 

Principal display panel


Base panel
Polyethylene Glycol 3350 NF
Powder for Solution, Osmotic Laxative
 
 
NDC 14539-150-20
Original Prescription Strength
Dissolves in Any Beverage
30 ONCE-DAILY DOSES
Net Wt. 510 g
Polyethylene Glycol 3350 NF increases frequency of bowel movements and softens the stools.
 
Manufactured By:
Emcure Pharmaceuticals USA Inc.
21/B Cotters Lane
East Brunswick, NJ 08816, USA.
 
Top panel
Polyethylene Glycol 3350 NF
Powder for Solution, Osmotic Laxative
 
 
NDC 14539-150-20
PEEL HERE
Original Prescription Strength
30 ONCE-DAILY DOSES
Net Wt. 510 g
 
Drug Facts
Active ingredient (in each dose) Purpose
Polyethylene Glycol 3350,
17 g (cap filled to line).............Osmotic Laxative
 
Use
Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol.

Do not use if you have kidney disease, except under the advice and supervision of a doctor


Ask a doctor before use if you have
 

Ask a doctor or pharmacist before use if you are taking a prescription drug

When using this product you may have loose, watery, more frequent stools


Stop use and ask a doctor if
 

 

If Pregnant or breast-feeding, ask a health professional before use. 

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    none
 
Label

 
 
 
 
 
 
POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14539-150
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17 g
Product Characteristics
Color WHITE (Colorless upon dissolution) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14539-150-20 30 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202071 09/28/2011
Labeler - Emcure Pharmaceuticals USA Inc. (189630168)
Establishment
Name Address ID/FEI Business Operations
Emcure Pharmaceuticals USA Inc. 189630168 ANALYSIS(14539-150) , MANUFACTURE(14539-150)

Revised: 1/2013
Document Id: ca67721d-0287-46d2-bffe-83748f21f6fd
Set id: 6b95dddc-4265-416b-954a-683a592a6cfd
Version: 5
Effective Time: 20130118
 
Emcure Pharmaceuticals USA Inc.