GLYCOLAX OSMOTIC LAXATIVE- polyethylene glycol 3350 powder, for solution

GlycoLax by

Drug Labeling and Warnings

GlycoLax by is a Otc medication manufactured, distributed, or labeled by Lannett Company, Inc... Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

GLYCOLAX  OSMOTIC LAXATIVE
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62175-190
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 (white to off-white powder)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62175-190-07	119 g in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2009
2	NDC: 62175-190-14	238 g in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2009
3	NDC: 62175-190-30	510 g in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2009

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

Labeler - Lannett Company, Inc. (006422406)