Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 GLENMARK THERAPEUTICS INC., USA FDA Approved Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
FunFoxMeds box
Route
ORAL
Applications
ANDA203928
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each dose) (Can only) Polyethylene Glycol 3350 17 g (cap filled to line)
Inactive Ingredients
Inactive ingredients none
Strengths
17 g
Treats Conditions
Use Relieves Occasional Constipation Irregularity Generally Produces A Bowel Movement In 1 To 3 Days
Pill Appearance
Color: white

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0359556762079
UNII
G2M7P15E5P
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72657-196-16 Polyethylene 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 broken • Unflavored • Sugar Free • Dissolves in Any Beverage 45 ONCE-DAILY DOSES NET WT 26.9 OZ (765 g) EACH 45s Label front 45s Label back labelfront labelback

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72657-196-16 Polyethylene 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 broken • Unflavored • Sugar Free • Dissolves in Any Beverage 45 ONCE-DAILY DOSES NET WT 26.9 OZ (765 g) EACH 45s Label front 45s Label back labelfront labelback

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Active ingredient (in each dose) (Packet Only) Polyethylene Glycol 3350, 17 g

Do Not Use

Do not use if you have kidney disease, except under the advice and supervision of a doctor

When Using

When using this product you may have loose, watery, more frequent stools

Keep Out of Reach of Children

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

Questions

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 Elmwood Park, NJ 07407


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