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MiraLAX: Package Insert / Prescribing Info

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 Mar 10, 2025.

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:
o
use once a day
o
fill to top of white section in cap which is marked to indicate the correct dose (17 g)
o
stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
o
do not combine with starch-based thickeners used for difficulty swallowing
o
ensure that the powder is fully dissolved before drinking
o
do not drink if there are any clumps
o
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:
o
use once a day
o
stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
o
do not combine with starch-based thickeners used for difficulty swallowing
o
ensure that the powder is fully dissolved before drinking
o
do not drink if there are any clumps
o
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 is open or broken

Inactive ingredients

none

Questions or comments?

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

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Bayer, the Bayer Cross, Mix-In Pax and MiraLAX are registered trademarks of Bayer.

©2021 Bayer.

Pat.: patents.livewell.bayer.com

Dist. by: Bayer HealthCare LLC, Whippany, NJ 07981

Distributed By:

Cardinal Health

Dublin, OH 43017

L4532222-10225 / L4532222-20225

Principal Display Panel

NDC 55154-5035-6

MiraLAX®

Polyethylene Glycol 3350,

Powder for Solution, Osmotic Laxative

6 PACKETS NET WT 0.5OZ (17g)

3350 bag label
MIRALAX
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5035(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:55154-5035-66 in 1 BAG02/23/2009
117 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009
Labeler - Cardinal Health 107, LLC (118546603)

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