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 SKY Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

1-888-243-4363

SPL UNCLASSIFIED SECTION

Packaged by:
Novitium Pharma LLC
East Windsor, NJ 08520

Distributed by:
McKesson Corporation dba SKY Packaging
Memphis, TN 38141

Issued: 05/2024

LB4717-00

PRINCIPAL DISPLAY PANEL

NDC: 63739-760-03
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

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63739-760
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	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63739-760-03	30 in 1 CARTON	08/01/2024	08/02/2024
1	NDC: 63739-760-01	17 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 63739-760-04	100 in 1 CARTON	08/01/2024	09/30/2026
2	NDC: 63739-760-01	17 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 63739-760-02	14 in 1 CARTON	08/01/2024	06/30/2026
3	NDC: 63739-760-01	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	ANDA202850	08/01/2024

Labeler - SKY Packaging (140529962)