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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:14539-150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 335017 g
Product Characteristics
ColorWHITE (Colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14539-150-2030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20207109/28/2011
Labeler - Emcure Pharmaceuticals USA Inc. (189630168)
Establishment
NameAddressID/FEIBusiness Operations
Emcure Pharmaceuticals USA Inc.189630168ANALYSIS(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.