MIRALAX- polyethylene glycol 3350 powder, for solution 
Bayer HealthCare LLC.

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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)

PRINCIPAL DISPLAY PANEL - 17 g × 3 Packet Carton

3 Single Doses

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

Mix-In Pax

UNFLAVORED

POWDER

GRIT FREE

3 ONCE-DAILY DOSES


NET WT 0.5 OZ (17g) EACH

3 count carton

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

Easy to Pour Bottle

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 CartonBack label carton

PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton

10

Single Doses

MiraLAX®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED

POWDER

GRIT FREE

Mix-In Pax

10 ONCE-DAILY DOSES

10 PACKETS

NET WT 0.5 OZ (17g) EACH

10 Count Carton

PRINCIPAL DISPLAY PANEL - Twinpack 34 ounce daily doses

Twin Pack!

2 x 34 Doses

Easy to Pour Bottle

MirLAX

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED

POWDER

GRIT FREE

Constipation/Irregularity

34 ONCE-DAILY DOSES

NET WT 20.4 OZ (578 g)

MiraLax 34 Dose TwinpackMiraLax 34 Dose Back label

MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7268
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) 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 CARTON02/01/2007
117 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:11523-7268-824 in 1 CARTON02/01/2007
217 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:11523-7268-75 in 1 CARTON02/01/200701/01/2015
317 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:11523-7268-4765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
5NDC:11523-7268-920 in 1 CARTON02/01/2007
517 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/01/2007
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7234
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) 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; Type 0: Not a Combination Product02/01/2007
2NDC:11523-7234-2119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
3NDC:11523-7234-3238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
4NDC:11523-7234-4510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
5NDC:11523-7234-512 in 1 CARTON02/01/200701/01/2012
517 g in 1 PACKET; Type 0: Not a Combination Product
6NDC:11523-7234-617 g in 1 PACKET; Type 0: Not a Combination Product02/01/2007
7NDC:11523-7234-92 in 1 CELLO PACK02/01/200701/01/2014
7510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/01/2007
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7341
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) 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; Type 0: Not a Combination Product02/01/2007
2NDC:11523-7341-23 in 1 CARTON02/01/200709/30/2021
217 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/01/2007
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4357
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) 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, COMBINATION02/01/200701/01/2018
1765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:11523-4357-32 in 1 PACKAGE, COMBINATION02/01/2007
2578 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:11523-4357-524 in 1 CARTON05/01/2018
317 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:11523-4357-22 in 1 CARTON02/01/2007
420 in 1 CARTON
417 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/01/2007
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 10/2020
Document Id: b1cc7dea-6153-4b82-e053-2995a90a62a7
Set id: d69ce3d4-7ca4-4fe3-b49e-6655e48d6963
Version: 18
Effective Time: 20201016
 
Bayer HealthCare LLC.