GLYCOLAX OSMOTIC LAXATIVE - polyethylene glycol 3350 powder, for solution
Kremers Urban Pharmaceuticals Inc.

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Active ingredient

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

Purpose

Osmotic Laxative

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 or pharmacist before use if you are taking a prescription drug

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

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.

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
adults and children 17 years of age and older:
- fill to 17 grams line in cap for the correct dose
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- use once daily
- use no more than 7 days
children 16 years of age or under: ask a doctor

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

none

1-866-822-0068

Rev.3E

NDC 62175-190-30

Compare to the active ingredient in MiraLAX®*

GlycoLax®

Polythylene Glycol 3350, Powder for Solution, Osmotic Laxative

Original
Prescription
Strength

CONTAINS 30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

Distributed by: Kremers Urban Pharmaceuticals Inc., Princeton, NJ 08540, USA

GlycoLax® is not manufactured or distributed by Schering-Plough
HealthCare Products, Inc., distributor of MiraLAX®.
Lot.: Exp.:
L5757FB Rev. 2E

GLYCOLAX OSMOTIC LAXATIVE
polyethylene glycol 3350 powder, for solution

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350)	Polyethylene Glycol 3350	17 g in 17 g

Product Characteristics
Color	WHITE (white to off-white powder)	Score
Shape		Size
Flavor		Imprint Code
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090600	10/06/2009

Labeler - Kremers Urban Pharmaceuticals Inc. (006422406)

Establishment
Name	Address	ID/FEI	Operations
Kremers Urban Pharmaceuticals Inc.		006422406	MANUFACTURE

Revised: 01/2012 Kremers Urban Pharmaceuticals Inc.