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GLYCOLAX OSMOTIC LAXATIVE (polyethylene glycol 3350) powder, for solution
[Kremers Urban Pharmaceuticals Inc.]



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

Principal Display Panel - 510 g Bottle Label

INGREDIENTS & APPEARANCE

GLYCOLAX   OSMOTIC LAXATIVE
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Kremers Urban Pharmaceuticals Inc.006422406MANUFACTURE(62175-190)

Revised: 6/2012
 
Kremers Urban Pharmaceuticals Inc.