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

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Polyethylene Glycol 3350

Active Ingredient (in each dose)

Polyethylene Glycol 3350 USP, 17g

Purpose

Osmotic Laxative

Use

relieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days

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

nausea, vomiting or abdominal pain
a sudden change in bowel habits that lasts over 2 weeks
irritable bowel syndrome

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

you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
you get diarrhea
you need to use a laxative for longer than 1 week

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

do not take more than directed unless advised by your doctor
adults and children 17 years of age and older:
use once a day
stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
do not combine with starch-based thickeners used for difficulty swallowing
ensure that the powder is fully dissolved before drinking
do not drink if there are any clumps
do not use more than 7 days
children 16 years of age or under: ask a doctor

Other information

store at 20° to 25°C (68° to 77°F)
tamper-evident: do not use if printed foil pouch is open or broken

Inactive ingredients

None

Questions or comments?

1-800-308-6755

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623

10198 Rev 05/21

PRINCIPAL DISPLAY PANEL

NDC 62559-157-30
Polyethylene Glycol 3350
Powder for Solution,
Osmotic Laxative

Relieves Occasional Constipation/Irregularity
Softens Stool

Dissolves in any Beverage
Sugar free

30 Once-Daily Doses
30 Packets NET WT 0.5 oz (17 g) Each

30 Single Doses

Compare to MiraLAX® Active Ingredient
Carton-30pkt

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62559-157
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:62559-157-3030 in 1 CARTON03/24/2020
1NDC:62559-157-1717 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:62559-157-10100 in 1 CARTON03/24/2020
2NDC:62559-157-1717 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20285003/24/2020
Labeler - ANI Pharmaceuticals, Inc. (145588013)

Revised: 12/2023
Document Id: eb23102c-b563-4bf7-be2b-394e9cdad551
Set id: 1afff730-b2d3-4e01-8403-97f2ecef3a74
Version: 5
Effective Time: 20231220
 
ANI Pharmaceuticals, Inc.