POLYETHYLENE GLYCOL-3350 - polyethylene glycol-3350 powder, for solution 
Novel Laboratories, Inc.

----------

Polyethylene Glycol 3350, Powder for Oral Solution

Drug Facts

OTC - ACTIVE INGREDIENT

Active Ingredient (in each dose)..........................................Purpose

Polyethylene Glycol 3350, 17 g (cap filled to line).....................Laxative

Use

WARNINGS

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

OTC - DO NOT USE

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

OTC - ASK DOCTOR

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST

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

OTC - WHEN USING

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

OTC - STOP USE

Stop use and ask a doctor if

Drug Facts (continued)

OTC - PREGNANCY OR BREAST FEEDING

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

OTC - KEEP OUT OF REACH OF CHILDREN

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 INGREDIENT

Inactive Ingredients                             none

OTC - QUESTIONS

Questions or comments?

1-800-FDA-1088 (1-800-332-1088) or www.fda.gov

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6c926ac6-figure-016c926ac6-figure-026c926ac6-figure-03

POLYETHYLENE GLYCOL-3350 
polyethylene glycol-3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40032-312
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40032-312-07119 g in 1 BOTTLE
2NDC:40032-312-08238 g in 1 BOTTLE
3NDC:40032-312-14510 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107710/06/2009
Labeler - Novel Laboratories, Inc. (793518643)
ContactAddressTelephone NumberEmail Address
Anu Radha Subramanian
Address:400 Campus Drive
City, State, Zip:Somerset, NJ, 08873
Country:USA
++1908-603-6000;ext=6002ars@novellabs.net
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
NameAddressID/FEIBusiness Operations
Novel Laboratories, Inc.793518643MANUFACTURE, ANALYSIS, repack
Establishment
NameAddressID/FEIBusiness Operations
Dow Chemical Company801038019api manufacture

Revised: 10/2009
Document Id: 6c926ac6-90c6-4752-af3a-ddd0963137a6
Set id: 8094e26b-7280-4777-8ab9-826662be18ea
Version: 1
Effective Time: 20091006
 
Novel Laboratories, Inc.