MIRALAX- polyethylene glycol 3350 powder, for solution 
Cardinal Health 107, 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

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.

Directions (Bottle Only)

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

Directions (Packet Only)

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

Other information

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)

.

Overbagged with 6 x 17g packets per bag, NDC 55154-5035-6

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.

Distributed By:

Cardinal Health

Dublin, OH 43017

L4532222-11025 / L4532222-21025

Principal Display Panel

NDC 55154-5035-6

MiraLAX®

Polyethylene Glycol 3350,

Powder for Solution, Osmotic Laxative

6 PACKETS NET WT 0.5OZ (17g)

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)

Revised: 11/2025
Document Id: a30d3776-09c8-41aa-9282-ba2486632e07
Set id: 1771d3bf-954d-49ea-b260-3d356e5dcfa5
Version: 17
Effective Time: 20251107
 
Cardinal Health 107, LLC