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

MiraLAX®
Polyethylene Glycol 3350
Powder for Solution, Osmotic Laxative

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g

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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 of 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 you nausea, bloating or 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 the 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
  • adults and children 17 years of age and older:
    • stir and dissolve one packet of powder (17 g) 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 foil is open or broken

Inactive ingredients

none

Questions or comments?

1-800-MiraLAX (1-800-647-2529) or www.MiraLAX

PRINCIPAL DISPLAY PANEL - 17g Packet Carton

10 Packets

NDC 11523-7268-3

Original
Prescription
Strength

MiraLAX®
Polyethylene Glycol 3350
Powder for Solution, Osmotic Laxative

NeatPAX™
Travel Size

  • Relieves Occasional
    Constipation
    (Irregularity)
  • Softens Stool

10 PACKETS
EACH PACKET NET WT 0.5 OZ (17g)

10
ONCE-DAILY DOSES

MiraLAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7268
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
Product Characteristics
Color WHITE (Colorless upon dissolution) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:11523-7268-3 10 PACKET (PACKET) in 1 CARTON
1 1 POWDER, FOR SOLUTION (DOSE PACK) in 1 PACKET
2 NDC:11523-7268-8 24 PACKET (PACKET) in 1 CARTON
2 1 POWDER, FOR SOLUTION (DOSE PACK) in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022015 02/23/2009
Labeler - Schering-Plough HealthCare Products, Inc. (039137567)
Establishment
Name Address ID/FEI Operations
Schering Corporation 155914674 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions 806746405 PACK, LABEL
Revised: 07/2010
 
Schering-Plough HealthCare Products, Inc.



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