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

----------

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

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 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

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

PRINCIPAL DISPLAY PANEL

NDC 11534-180-19

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative

Unflavored Powder Grit Free

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

2ffddd92-figure-03

POLYETHYLENE GLYCOL 3350 NF 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-180
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:11534-180-19119 g in 1 BOTTLE; Type 0: Not a Combination Product06/13/2017
2NDC:11534-180-28238 g in 1 BOTTLE; Type 0: Not a Combination Product06/13/2017
3NDC:11534-180-50510 g in 1 BOTTLE; Type 0: Not a Combination Product06/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20610506/13/2017
Labeler - SUNRISE PHARMACEUTICAL, INC (168522378)
Registrant - SUNRISE PHARMACEUTICAL, INC (168522378)
Establishment
NameAddressID/FEIBusiness Operations
SUNRISE PHARMACEUTICAL INC.168522378MANUFACTURE(11534-180) , ANALYSIS(11534-180) , PACK(11534-180)

Revised: 1/2020
Document Id: 020b7f87-0f3a-4223-a402-dea12a6c53d2
Set id: ce5197a1-2677-4ffb-aef2-9221b28ebd23
Version: 2
Effective Time: 20200122
 
SUNRISE PHARMACEUTICAL, INC