MIRALAX- polyethylene glycol 3350 powder, for solution 
MSD Consumer Care, Inc.

----------

MiraLAX®

Drug Facts

Active ingredient (in each dose) (Bottle Only)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

Osmotic Laxative

Active ingredient (in each dose) (Packet Only)

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

  • 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 (Bottle Only)

Directions (Packet Only)

Other information

Inactive ingredients

none

Questions or comments?

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

Distributed by MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA, a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton

10
Packets

NDC 11523-7268-3

MiraLAX®
Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED
POWDER
GRIT FREE

NeatPAX®

10 ONCE-DAILY DOSES

10 PACKETS
NET WT 0.5 OZ (17g) EACH

PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

NDC 11523-7234-4

Original
Prescription
Strength

MiraLAX®

Polyethylene Glycol 3350
Powder for Solution, Osmotic Laxative

30
ONCE-DAILY
DOSES

NET WT 17.9 OZ (510 g)

Principal Display Panel - 510 g Bottle Label

PRINCIPAL DISPLAY PANEL - 17 g × 3 Packet Carton

Trial
Pack

NDC 11523-7341-02

MiraLAX®
Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED
POWDER
GRIT FREE

NeatPAX®

3 ONCE-DAILY DOSES

3 PACKETS
NET WT 0.5 OZ (17g) EACH

Principal Display Panel - 17 g × 3 Packet Carton

PRINCIPAL DISPLAY PANEL - Twin Pack - 765 g Bottle Label

Value
Size

NDC 11523-4357-1

MiraLAX®
Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED
POWDER
GRIT FREE

45 ONCE-DAILY DOSES
NET WT 26.9 OZ (765g)

32660-01

Principal Display Panel - Twin Pack - 765 g Bottle Label
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7268
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) Polyethylene Glycol 335017 g  in 17 g
Product Characteristics
ColorWHITE (Colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7268-310 in 1 CARTON
117 g in 1 PACKET
2NDC:11523-7268-824 in 1 CARTON
217 g in 1 PACKET
3NDC:11523-7268-75 in 1 CARTON
317 g in 1 PACKET
4NDC:11523-7268-4765 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7234
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) Polyethylene Glycol 335017 g  in 17 g
Product Characteristics
ColorWHITE (Colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7234-117 g in 1 PACKET
2NDC:11523-7234-2119 g in 1 BOTTLE, PLASTIC
3NDC:11523-7234-3238 g in 1 BOTTLE, PLASTIC
4NDC:11523-7234-4510 g in 1 BOTTLE, PLASTIC
5NDC:11523-7234-512 in 1 CARTON
517 g in 1 PACKET
6NDC:11523-7234-617 g in 1 PACKET
7NDC:11523-7234-72 in 1 CARTON
717 g in 1 PACKET
8NDC:11523-7234-872 in 1 CARTON
817 g in 1 PACKET
9NDC:11523-7234-92 in 1 CELLO PACK
9510 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7341
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) Polyethylene Glycol 335017 g  in 17 g
Product Characteristics
ColorWHITE (Colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7341-1612 g in 1 BOTTLE, PLASTIC
2NDC:11523-7341-23 in 1 CARTON
217 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-4357
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) Polyethylene Glycol 335017 g  in 17 g
Product Characteristics
ColorWHITE (colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-4357-12 in 1 PACKAGE, COMBINATION
1765 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009
Labeler - MSD Consumer Care, Inc. (968091715)
Establishment
NameAddressID/FEIBusiness Operations
Merck Sharp & Dohme Corp040947439MANUFACTURE(11523-7268, 11523-7234, 11523-7341, 11523-4357)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Pharma Solutions078465146PACK(11523-7268, 11523-7234, 11523-7341, 11523-4357)
Establishment
NameAddressID/FEIBusiness Operations
Braintree Laboratories, Inc.617357954MANUFACTURE(11523-7234, 11523-7341), PACK(11523-7234, 11523-7341)
Establishment
NameAddressID/FEIBusiness Operations
New-Tech Packaging, Inc.115281644PACK(11523-7234, 11523-7268, 11523-7341, 11523-4357)
Establishment
NameAddressID/FEIBusiness Operations
PTI Union LLC807308858MANUFACTURE(11523-7234, 11523-7341), PACK(11523-7234, 11523-7341)
Establishment
NameAddressID/FEIBusiness Operations
PTI Royston LLC601006997MANUFACTURE(11523-7268, 11523-7234, 11523-7341, 11523-4357), PACK(11523-7268, 11523-7234, 11523-7341, 11523-4357)

Revised: 4/2014
Document Id: 025c2b9f-bd54-4613-8cb5-82a612d6c1a1
Set id: d69ce3d4-7ca4-4fe3-b49e-6655e48d6963
Version: 9
Effective Time: 20140411
 
MSD Consumer Care, Inc.