POLYETHYLENE GLYCOL 3350 NF - polyethylene glycol 3350 powder, for solution 
NUVO PHARMACEUTICAL INC.

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Polyethylene Glycol 3350 powder, for solution

Drug Facts

Active ingredient (in each dose)                     

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

Purpose

Osmotic Laxative

Uses

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 doctor or pharmacist before use if you are

taking a prescription drug

When Using this product

you may 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 INGREDIENT

None

Questions or comments?

1-800-FDA-1088

Distributed by:
Nuvo Pharmaceutical, Inc.
Rahway, NJ 07065

Manufactured by:
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065

PRINCIPAL DISPLAY PANEL-119 g per Bottle

NDC 425756-180-19

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative

Unflavored Powder Grit Free

Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool.

9a6f7c98-figure-03

POLYETHYLENE GLYCOL 3350 NF 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42576-180
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:42576-180-19119 g in 1 BOTTLE; Type 0: Not a Combination Product07/03/2017
2NDC:42576-180-28238 g in 1 BOTTLE; Type 0: Not a Combination Product07/03/2017
3NDC:42576-180-50510 g in 1 BOTTLE; Type 0: Not a Combination Product07/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20610507/03/2017
Labeler - NUVO PHARMACEUTICAL INC. (078366708)
Registrant - NUVO PHARMACEUTICAL INC. (078366708)
Establishment
NameAddressID/FEIBusiness Operations
SUNRISE PHARMACEUTICAL INC.168522378MANUFACTURE(42576-180) , ANALYSIS(42576-180) , PACK(42576-180)

Revised: 1/2017
Document Id: 9a6f7c98-8459-40a6-99c2-03a990ae69d2
Set id: 49c3aa94-3b32-4929-b9c6-52e3f58e4a57
Version: 3
Effective Time: 20170127
 
NUVO PHARMACEUTICAL INC.