POLYETHYLENE GLYCOL 3350 powder, for solution

Polyethylene Glycol 3350 by

Drug Labeling and Warnings

Polyethylene Glycol 3350 by is a Otc medication manufactured, distributed, or labeled by Kesin Pharma Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Polyethylene Glycol 3350 increases frequency of bowel movements and softens stools

Drug Facts

Active ingredient (in each dose)

Polyethlene Glycol 3350, 17 g

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 need to use a laxative for longer than 1 week
• you get diarrhea

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

• do not take more than directed unless advised by your doctor
• adults and children 17 yearsof age and older:
• use once a day
• stir and dissolve one packet of powder (17 g) in any 4 to 8 ounce of beverage (cold, hot or room temperature) then drink
• do not combine with starch-based thickners 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°C to 25°C (68°F to 77°F)
• tamper-evident: do not use if printed foil pouch is open or broken
• this package is not child-resistant

Inactive ingredients

none

Questions or comments?

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL POUCH IS OPEN OR BROKEN

*This product is not manufactured by Bay HealthCare LLC, owner of the registered trademark MiraLAX ®

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 81033-762-14

Polyethylene Glycol 3350 Powder for Oral Solution

Osmotic Laxative

14 Packets

(14 once-daily-doses)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 81033-762-30

Polyethylene Glycol 3350 Powder for Oral Solution

Osmotic Laxative

30 Packets

(30 once-daily doses)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 81033-762-01

Polyethylene Glycol 3350 Powder for Oral Solution

Osmotic laxative

100 Packets

(100 once-daily doses)

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-762(NDC:59556-762)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g  in 17 g

Product Characteristics
Color	white (Colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-762-14	14 in 1 CARTON	06/09/2025
1	NDC: 81033-762-17	17 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 81033-762-30	30 in 1 CARTON	06/09/2025
2	NDC: 81033-762-17	17 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 81033-762-01	100 in 1 CARTON	06/09/2025
3	NDC: 81033-762-17	17 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203928	06/09/2025

Labeler - Kesin Pharma Corporation (117447816)

Establishment
Name	Address	ID/FEI	Business Operations
Kesin Pharma Corporation		117447816	label(81033-762) , pack(81033-762) , repack(81033-762)