PEG 3350- polyethylene glycol 3350 powder, for solution 
Major Pharmaceuticals

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Major Pharmaceuticals PEG 3350 Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (in each level scoop)

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. (1-800-222-1222)

Directions

  • do not take more than directed unless advised by your doctor
  • the enclosed scoop is a measuring device designed to contain 17 grams of powder when filled to the top (level scoop)
  • adults and children 17 years of age and older:
  • fill scoop completely with product to obtain the correct dose (17 g). Level scoop with knife or flat object.
  • 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

Principal Display Panel

Easy to Open Cap!

Compare to MiraLAX® active ingredient

PEG 3350

Original Prescription Strength

Polyethylene Glycol 3350

Powder for Solution, Laxative

Relieves Occasional Constipation

Softens Stool

This Package For Households Without Young Children

# Once-Daily Doses

PEG 3350 Label

PEG 3350 Label

PEG 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6025
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
ColorWHITE (or almost whtie) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6025-84850 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068510/08/2009
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2009
Document Id: 829f74ba-f010-42b5-8169-61c11349418f
Set id: 829f74ba-f010-42b5-8169-61c11349418f
Version: 1
Effective Time: 20091008
 
Major Pharmaceuticals