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 Cardinal Health 107, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each dose)

Polyethylene 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 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:
  • o use once a day
  • o stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • o do not combine with starch-based thickeners used for difficulty swallowing
  • o ensue that the powder is fully dissolved before drinking
  • o do not drink if there are any clumps
  • o use no more than 7 days
• children 16 years of age or under: ask a doctor

Other information

• store at 20º to 25ºC (68º to 77ºF)
• tamper-evident: do not use if foil is open or broken

Inactive ingredients

none

Questions or comments?

(800) 616-2471

This product

Is not manufactured or distributed by Baxter Healthcare LLC, owner of the registered trademark MiraLAX®.

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Rev. 03/22	M-17	Re-order No. 701067
Product of India	50844	REV0222C72601

Distributed By:

Cardinal Health

Dublin, OH 43017

L56089710724

WARNING: This Unit Dose package is not child resistant and is Intended of Institutional Use Only.

Principal Display Panel

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

5 -Packets NET WT 0.5 OZ (17 g) EACH

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-8090(NDC:0904-6931)
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: 55154-8090-5	5 in 1 BAG	06/30/2019
1		17 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203928	06/30/2019

Labeler - Cardinal Health 107, LLC (118546603)