MiraLAX® Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative

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 TypeHUMAN OTC DRUGNDC Product Code (Source)11523-7268
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) Polyethylene Glycol 335017 g
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorWHITE (Colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
111523-7268-310 PACKET In 1 CARTONcontains a PACKET
11 DOSE PACK In 1 PACKETThis package is contained within the CARTON (11523-7268-3)
211523-7268-824 PACKET In 1 CARTONcontains a PACKET
21 DOSE PACK In 1 PACKETThis package is contained within the CARTON (11523-7268-8)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009

Labeler - Schering-Plough HealthCare Products, Inc. (039137567)
Establishment
NameAddressID/FEIOperations
Schering Corporation155914674MANUFACTURE
Establishment
NameAddressID/FEIOperations
Catalent Pharma Solutions806746405PACK, LABEL
Revised: 07/2010Schering-Plough HealthCare Products, Inc.