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 GLENMARK THERAPEUTICS INC., USA, Strides Pharma Science Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Polyethylene Glycol 3350, Powder for Solution

Drug Facts

Active ingredient (in each dose) (Can only)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

Osmotic Laxative

Active ingredient (in each dose) (Packet Only)

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 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (Can Only)

• do not take more than directed unless advised by your doctor
• the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
• adults and children 17 years of age and older:
  • o use once a day
  • o fill to top of white section in cap which is marked to indicate the correct dose (17 g)
  • o stir and dissolve 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 ensure that the powder is fully dissolved before drinking
  • o do not drink if there are any clumps
  • o do not use more than 7 days
• children 16 years of age or under: ask a doctor

Directions (Packet Only)

• 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 ensure that the powder is fully dissolved before drinking
  • o do not drink if there are any clumps
  • o do not use more than 7 days
• children 16 years of age or under: ask a doctor

Other Information

• store at 20° - 25°C (68° - 77°F)
• tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive ingredients

none

Questions or comments?

Call weekdays 9 AM to 5 PM at 1 (888) 721-7115

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

Distributed by

Glenmark Therapeutics Inc., USA

Mahwah, NJ 07430

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 72657-196-16Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

• Relieves Occasional Constipation (Irregularity)
• Softens Stool
• TAMPER-EVIDENT: do not use if printed foil seal under cap is missing, open or brokenUnflavoredf
• Sugar Free
• Dissolves in Any Beverage

45 ONCE-DAILY DOSES

NET WT 26.9 OZ (765 g) EACH

45s Label front

45s Label back

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72657-196
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: 72657-196-16	765 g in 1 CAN; Type 0: Not a Combination Product	09/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203928	09/19/2024

Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Pharma Science Limited		918513263	ANALYSIS(72657-196) , MANUFACTURE(72657-196) , PACK(72657-196)