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MiraLAX

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

Medically reviewed by Drugs.com. Last updated on Feb 1, 2022.

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:
    • 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

Directions (Packet Only)

  • 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

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)

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

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

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)

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)

MiraLAX
polyethylene glycol 3350 powder, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7268
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) 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
1 NDC:11523-7268-3 10 PACKET in 1 CARTON
1 17 g in 1 PACKET
2 NDC:11523-7268-8 24 PACKET in 1 CARTON
2 17 g in 1 PACKET
3 NDC:11523-7268-7 5 PACKET in 1 CARTON
3 17 g in 1 PACKET
4 NDC:11523-7268-4 765 g in 1 BOTTLE, PLASTIC
5 NDC:11523-7268-9 20 POUCH in 1 CARTON
5 17 g in 1 POUCH
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) 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
1 NDC:11523-7234-1 17 g in 1 PACKET
2 NDC:11523-7234-2 119 g in 1 BOTTLE, PLASTIC
3 NDC:11523-7234-3 238 g in 1 BOTTLE, PLASTIC
4 NDC:11523-7234-4 510 g in 1 BOTTLE, PLASTIC
5 NDC:11523-7234-5 12 PACKET in 1 CARTON
5 17 g in 1 PACKET
6 NDC:11523-7234-6 17 g in 1 PACKET
7 NDC:11523-7234-9 2 BOTTLE, PLASTIC in 1 CELLO PACK
7 510 g in 1 BOTTLE, PLASTIC
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) 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
1 NDC:11523-7341-1 612 g in 1 BOTTLE, PLASTIC
2 NDC:11523-7341-2 3 PACKET in 1 CARTON
2 17 g in 1 PACKET
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) 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
1 NDC:11523-4357-1 2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION
1 765 g in 1 BOTTLE, PLASTIC
2 NDC:11523-4357-3 2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION
2 578 g in 1 BOTTLE, PLASTIC
3 NDC:11523-4357-5 24 PACKET in 1 CARTON
3 17 g in 1 PACKET
4 NDC:11523-4357-2 2 CARTON in 1 CARTON
4 20 PACKET in 1 CARTON
4 17 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022015 02/01/2007
Labeler - Bayer HealthCare LLC. (112117283)
Bayer HealthCare LLC.

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