Polyethylene Glycol Drug Facts

Generic Name: polyethylene glycol 3350
Dosage Form: powder, for solution
Drug Facts

Active ingredient

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

Purpose

Laxative

Uses

• 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?

1-800-477-7877

Distributed by

Kremers Urban, LLC

Princeton, NJ 08540 USA

Rev. 1E

Principal Display Panel

Original Prescription Strength

• Relieves Occasional Constipation
• Softens Stool
• 

  4.1 oz Label. Drug Facts on ECL.

• 

  8.9 oz Label. Drug Facts on ECL.

• 

  18.5 oz Label. Drug Facts on ECL.

POLYETHYLENE GLYCOL 3350  polyethylene glycol 3350  powder, for solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 62175-195 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 17 g  in 17 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 62175-195-07 119 g In 1 BOTTLE None 2 62175-195-15 255 g In 1 BOTTLE None 3 62175-195-31 527 g In 1 BOTTLE None

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

Labeler - Kremers Urban (015411751)

Revised: 03/2010Kremers Urban