MIRALAX- polyethylene glycol 3350 powder, for solution 
Bayer HealthCare

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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

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

Easy to Pour Bottle

NDC 11523-7234-4

MiraLAX®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED

POWDER

GRIT FREE

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

front label

back 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 Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7268
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17 g  in 17 g
Product Characteristics
Color white (Colorless upon dissolution) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-7268-3 10 in 1 CARTON 02/01/2007
1 17 g in 1 PACKET; Type 0: Not a Combination Product
2 NDC:11523-7268-8 24 in 1 CARTON 02/01/2007
2 17 g in 1 PACKET; Type 0: Not a Combination Product
3 NDC:11523-7268-7 5 in 1 CARTON 02/01/2007
3 17 g in 1 PACKET; Type 0: Not a Combination Product
4 NDC:11523-7268-4 765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022015 02/01/2007
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7234
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17 g  in 17 g
Product Characteristics
Color white (Colorless upon dissolution) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-7234-1 17 g in 1 PACKET; Type 0: Not a Combination Product 02/01/2007
2 NDC:11523-7234-2 119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007
3 NDC:11523-7234-3 238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007
4 NDC:11523-7234-4 510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007
5 NDC:11523-7234-5 12 in 1 CARTON 02/01/2007
5 17 g in 1 PACKET; Type 0: Not a Combination Product
6 NDC:11523-7234-6 17 g in 1 PACKET; Type 0: Not a Combination Product 02/01/2007
7 NDC:11523-7234-9 2 in 1 CELLO PACK 02/01/2007
7 510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022015 02/01/2007
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7341
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17 g  in 17 g
Product Characteristics
Color white (Colorless upon dissolution) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-7341-1 612 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007
2 NDC:11523-7341-2 3 in 1 CARTON 02/01/2007
2 17 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022015 02/01/2007
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-4357
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17 g  in 17 g
Product Characteristics
Color white (colorless upon dissolution) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-4357-1 2 in 1 PACKAGE, COMBINATION 02/01/2007
1 765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:11523-4357-3 2 in 1 PACKAGE, COMBINATION 02/01/2007
2 578 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022015 02/01/2007
Labeler - Bayer HealthCare (968091715)

Revised: 4/2016
Document Id: 318dd24c-c10e-2ecd-e054-00144ff88e88
Set id: d69ce3d4-7ca4-4fe3-b49e-6655e48d6963
Version: 10
Effective Time: 20160428
 
Bayer HealthCare