MIRALAX- polyethylene glycol 3350 powder, for solution

MiraLAX by

Drug Labeling and Warnings

MiraLAX by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:
  • 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
  • use once a day
  • 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:
  • stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • use once a day
  • use no 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 × 3 Packet Carton

3 Single Doses

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

Mix-In Pax

UNFLAVORED

POWDER

GRIT FREE

• Relieves Occasional
  Constipation/Irregularity
• Softens Stool

3 ONCE-DAILY DOSES

NET WT 0.5 OZ (17g) EACH

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

Easy to Pour Bottle

MiraLAX®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

• Relieves Occasional Constipation/Irregularity
• Softens Stool

UNFLAVORED

POWDER

GRIT FREE

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton

10

Single Doses

MiraLAX®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED

POWDER

GRIT FREE

• Relieves Occasional
  
  Constipation/Irregularity
• Softens Stool

Mix-In Pax

10 ONCE-DAILY DOSES

10 PACKETS

NET WT 0.5 OZ (17g) EACH

PRINCIPAL DISPLAY PANEL - Twinpack 34 ounce daily doses

Twin Pack!

2 x 34 Doses

Easy to Pour Bottle

MirLAX

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED

POWDER

GRIT FREE

• Relieves Occasional

Constipation/Irregularity

• Softens Stool

34 ONCE-DAILY DOSES

NET WT 20.4 OZ (578 g)

INGREDIENTS AND APPEARANCE

MIRALAX 
polyethylene glycol 3350 powder, for solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022015	02/01/2007

Labeler - Bayer HealthCare LLC. (112117283)