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FDA > Polyethylene Glycol Drug Facts

Polyethylene Glycol Drug Facts

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Generic Name: polyethylene glycol 3350
Dosage Form: powder
Perrigo Polyethylene Glycol 3350 Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (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 (white section in cap)
  • adults and children 17 years of age and older:
  • fill to top of white section in cap which is marked to indicate the correct dose (17 g)
  • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • use once a day
  • 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?

1-800-719-9260

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Compare to MiraLAX® active ingredient

Polyethylene Glycol 3350

Powder for Solution, Laxative

Relieves Occasional Constipation

Softens Stool

Original Prescription Strength

# Ounce-Daily Doses

Polyethylene Glycol 3350 Label


POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350  powder
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 45802-868
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 WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 45802-868-01 119 g In 1 BOTTLE None
2 45802-868-03 510 g In 1 BOTTLE None
3 45802-868-02 238 g In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090685 10/13/2009

Labeler - Perrigo New York Inc (078846912)
Revised: 10/2009Perrigo New York Inc



 


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