Polyethylene Glycol 3350 NF PEGYLAX

Name: Polyethylene Glycol 3350 NF PEGYLAX

Indications and Usage for Polyethylene Glycol 3350 NF PEGYLAX

For the treatment of occasional constipation. This product should be used for 2 weeks or less or as directed by a physician.

Adverse Reactions

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients.

Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.

Polyethylene Glycol 3350 NF PEGYLAX Dosage and Administration

The usual dose is 17 grams (about 1 heaping tablespoonful) of powder per day (or as directed by physician) in 4 - 8 ounces of water, juice, soda, coffee, or tea. Each bottle of Polyethylene Glycol 3350, NF is supplied with a dosing cap marked to contain 17 grams of laxative powder when filled to the indicated line.

Two to 4 days (48 to 96 hours) may be required to produce a bowel movement.

PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

AvKARE

NDC 42291-673-25

Polyethylene Glycol 3350, NF
Powder for Oral Solution

This bottle contains
255 grams of polyethylene glycol 3350, NF powder

PRESCRIPTION LAXATIVE

Rx Only

CIA78337B         Rev. 07/16

POLYETHYLENE GLYCOL 3350  
polyethylene glycol 3350 powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42291-673
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 1 g  in 1 g
Product Characteristics
Color WHITE (White to Off-White) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:42291-673-25 255 g in 1 BOTTLE
2 NDC:42291-673-57 527 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076652 07/05/2013
Labeler - AvKARE, Inc. (796560394)
Revised: 07/2016   AvKARE, Inc.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Belly pain.
  • Stomach cramps.
  • Gas.
  • Bloating.
  • Upset stomach.
  • More frequent stools.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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