GlycoLax Osmotic Laxative

Dosage form: powder, for solution
Ingredients: Polyethylene Glycol 3350 17g in 17g
Labeler: Kremers Urban Pharmaceuticals Inc.
NDC Code: 62175-190

Drug Facts

Active ingredient

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

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
  • 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

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

Inactive ingredients

none

Questions or comments?

1-866-822-0068

Rev.3E

Principal Display Panel - 510 g Bottle Label

NDC 62175-190-30

Compare to the active ingredient in MiraLAX®*

GlycoLax®

Polythylene Glycol 3350, Powder for Solution, Osmotic Laxative

Original
Prescription
Strength

  • Softens Stool
  • Relieves Occasional Constipation (Irregularity)

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.:
CIA76417A     Rev. 3E

GLYCOLAX   OSMOTIC LAXATIVE
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62175-190
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) Polyethylene Glycol 335017 g  in 17 g
Product Characteristics
ColorWHITE (white to off-white powder) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62175-190-07119 g in 1 BOTTLE
2NDC:62175-190-14238 g in 1 BOTTLE
3NDC:62175-190-30510 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09060010/06/2009
Labeler - Kremers Urban Pharmaceuticals Inc. (006422406)
Establishment
NameAddressID/FEIOperations
Kremers Urban Pharmaceuticals Inc.006422406MANUFACTURE(62175-190)

Revised: 06/2012
 
Kremers Urban Pharmaceuticals Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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