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MiraLAX Prescribing Information

Package insert / product label
Generic name: polyethylene glycol 3350
Dosage form: powder, for solution
Drug class: Laxatives

Medically reviewed by Drugs.com. Last updated on Dec 13, 2023.

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

Indications and Usage for MiraLAX

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days

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.

MiraLAX Dosage and Administration

  • do not take more than directed unless advised by your doctor
  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
  • adults and children 17 years of age and older:
    • use once a day
    • fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • do not combine with starch-based thickeners used for difficulty swallowing
    • ensure that the powder is fully dissolved before drinking
    • do not drink if there are any clumps
    • do not use no more than 7 days
  • children 16 years of age or under: ask a doctor

MiraLAX Dosage and Administration

  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • use once a day
    • stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • do not combine with starch-based thickeners used for difficulty swallowing
    • ensure that the powder is fully dissolved before drinking
    • do not drink if there are any clumps
    • do not use more than 7 days
  • children 16 years of age or under: ask a doctor

Storage and Handling

  • store at 20°-25°C (68°-77°F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive ingredients

none

Questions or comments?

1-800-MiraLAX (1-800-647-2529)

PRINCIPAL DISPLAY PANEL - 17 g × 20 Packet Carton

20

Single Doses

#1 DOCTOR RECOMMENDED BRAND

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

Mix-In Pax ®

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

20

ONCE-DAILY DOSES

Bayer

Unflavored Powder Dissolves in ANY Beverage!

UNFLAVORED
POWDER
GRIT FREE

20 PACKETS

NET WT 0.5 OZ

(17g) EACH

20ct Carton

PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton

10

Single Doses

#1 DOCTOR RECOMMENDED BRAND

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

Mix-In Pax ®

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

10

ONCE-DAILY DOSES

Bayer

Unflavored Powder Dissolves in ANY Beverage!

UNFLAVORED
POWDER
GRIT FREE

10 PACKETS
NET WT 0.5 OZ

(17g) EACH

10ct Carton

PRINCIPAL DISPLAY PANEL - 30 Dose (510 g) Bottle Label

Easy to Pour Bottle

#1 DOCTOR RECOMMENDED BRAND

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED

POWDER

GRIT FREE

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

Bayer

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

30 Front

30 Dose - Back

PRINCIPAL DISPLAY PANEL - Twinpack 2x34 Dose (578 g) Bottle Label

Twin Pack!

2 x 34 Doses

Easy to Pour Bottle

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

#1 DOCTOR RECOMMENDED BRAND

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

UNFLAVORED

POWDER

GRIT FREE

Bayer

34 ONCE-DAILY DOSES

NET WT 20.4 OZ (578 g)

34 Dose Front

34 Dose Back

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 CARTON02/01/2007
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)

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