MIRALAX - polyethylene glycol 3350 powder, for solution 
Schering-Plough HealthCare Products, Inc.

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MiraLAX®
Polyethylene Glycol 3350
Powder for Solution, Osmotic Laxative

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g

Purpose

Osmotic Laxative

Use

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

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

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

Other information

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

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

10
ONCE-DAILY DOSES

PRINCIPAL DISPLAY PANEL - 17g Packet Carton

MIRALAX 
polyethylene glycol 3350   powder, for solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 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
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color WHITE (Colorless upon dissolution) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 11523-7268-3 10 PACKET In 1 CARTON contains a PACKET
1 1 DOSE PACK In 1 PACKET This package is contained within the CARTON (11523-7268-3)
2 11523-7268-8 24 PACKET In 1 CARTON contains a PACKET
2 1 DOSE PACK In 1 PACKET This package is contained within the CARTON (11523-7268-8)

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.