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

Single Doses

#1 DOCTOR RECOMMENDED BRAND

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

Mix-In Pax ®

Relieves Occasional Constipation/Irregularity
Softens Stool

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

Single Doses

#1 DOCTOR RECOMMENDED BRAND

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

Mix-In Pax ®

Relieves Occasional Constipation/Irregularity
Softens Stool

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-7268
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g in 17 g

Product Characteristics
Color	white (Colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-7268-3	10 in 1 CARTON	02/01/2007
1		17 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:11523-7268-8	24 in 1 CARTON	02/01/2007
2		17 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC:11523-7268-7	5 in 1 CARTON	02/01/2007	01/01/2015
3		17 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC:11523-7268-4	765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2007
5	NDC:11523-7268-9	20 in 1 CARTON	02/01/2007
5		17 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g in 17 g

Product Characteristics
Color	white (Colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-7234-1	17 g in 1 PACKET; Type 0: Not a Combination Product	02/01/2007
2	NDC:11523-7234-2	119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2007
3	NDC:11523-7234-3	238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2007
4	NDC:11523-7234-4	510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2007
5	NDC:11523-7234-5	12 in 1 CARTON	02/01/2007	01/01/2012
5		17 g in 1 PACKET; Type 0: Not a Combination Product
6	NDC:11523-7234-6	17 g in 1 PACKET; Type 0: Not a Combination Product	02/01/2007
7	NDC:11523-7234-9	2 in 1 CELLO PACK	02/01/2007	01/01/2014
7		510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g in 17 g

Product Characteristics
Color	white (Colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11523-7341-1	612 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2007
2	NDC:11523-7341-2	3 in 1 CARTON	02/01/2007
2		17 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g in 17 g

Product Characteristics
Color	white (colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-4357-1	2 in 1 PACKAGE, COMBINATION	02/01/2007	01/01/2018
1		765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:11523-4357-3	2 in 1 PACKAGE, COMBINATION	02/01/2007
2		578 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:11523-4357-5	24 in 1 CARTON	05/01/2018
3		17 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC:11523-4357-2	2 in 1 CARTON	02/01/2007
4		20 in 1 CARTON
4		17 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA022015	02/01/2007

Labeler - Bayer HealthCare LLC. (112117283)