Your browser does not support JavaScript! MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MSD CONSUMER CARE, INC.]
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MIRALAX (polyethylene glycol 3350) powder, for solution
[MSD Consumer Care, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

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) or www.MiraLAX.com

Distributed by MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA, a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton

10
Packets

NDC 11523-7268-3

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

UNFLAVORED
POWDER
GRIT FREE

  • Relieves Occasional
    Constipation/Irregularity
  • Softens Stool

NeatPAX®

10 ONCE-DAILY DOSES

10 PACKETS
NET WT 0.5 OZ (17g) EACH

PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

NDC 11523-7234-4

Original
Prescription
Strength

MiraLAX®

Polyethylene Glycol 3350
Powder for Solution, Osmotic Laxative

  • Relieves Occasional
    Constipation (Irregularity)
  • Softens Stool

30
ONCE-DAILY
DOSES

NET WT 17.9 OZ (510 g)

Principal Display Panel - 510 g Bottle Label

PRINCIPAL DISPLAY PANEL - 17 g × 3 Packet Carton

Trial
Pack

NDC 11523-7341-02

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

UNFLAVORED
POWDER
GRIT FREE

  • Relieves Occasional
    Constipation/Irregularity
  • Softens Stool

NeatPAX®

3 ONCE-DAILY DOSES

3 PACKETS
NET WT 0.5 OZ (17g) EACH

Principal Display Panel - 17 g × 3 Packet Carton

PRINCIPAL DISPLAY PANEL - Twin Pack - 765 g Bottle Label

Value
Size

NDC 11523-4357-1

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

UNFLAVORED
POWDER
GRIT FREE

  • Relieves Occasional
    Constipation/Irregularity
  • Softens Stool

45 ONCE-DAILY DOSES
NET WT 26.9 OZ (765g)

32660-01

Principal Display Panel - Twin Pack - 765 g Bottle Label
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7268
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) 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:11523-7268-310 in 1 CARTON
117 g in 1 PACKET
2NDC:11523-7268-824 in 1 CARTON
217 g in 1 PACKET
3NDC:11523-7268-75 in 1 CARTON
317 g in 1 PACKET
4NDC:11523-7268-4765 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7234
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) 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:11523-7234-117 g in 1 PACKET
2NDC:11523-7234-2119 g in 1 BOTTLE, PLASTIC
3NDC:11523-7234-3238 g in 1 BOTTLE, PLASTIC
4NDC:11523-7234-4510 g in 1 BOTTLE, PLASTIC
5NDC:11523-7234-512 in 1 CARTON
517 g in 1 PACKET
6NDC:11523-7234-617 g in 1 PACKET
7NDC:11523-7234-72 in 1 CARTON
717 g in 1 PACKET
8NDC:11523-7234-872 in 1 CARTON
817 g in 1 PACKET
9NDC:11523-7234-92 in 1 CELLO PACK
9510 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7341
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) 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:11523-7341-1612 g in 1 BOTTLE, PLASTIC
2NDC:11523-7341-23 in 1 CARTON
217 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009
MIRALAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-4357
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) 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:11523-4357-12 in 1 PACKAGE, COMBINATION
1765 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009
Labeler - MSD Consumer Care, Inc. (968091715)
Establishment
NameAddressID/FEIBusiness Operations
Merck Sharp & Dohme Corp040947439MANUFACTURE(11523-7268, 11523-7234, 11523-7341, 11523-4357)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Pharma Solutions078465146PACK(11523-7268, 11523-7234, 11523-7341, 11523-4357)
Establishment
NameAddressID/FEIBusiness Operations
Braintree Laboratories, Inc.617357954MANUFACTURE(11523-7234, 11523-7341), PACK(11523-7234, 11523-7341)
Establishment
NameAddressID/FEIBusiness Operations
New-Tech Packaging, Inc.115281644PACK(11523-7234, 11523-7268, 11523-7341, 11523-4357)
Establishment
NameAddressID/FEIBusiness Operations
PTI Union LLC807308858MANUFACTURE(11523-7234, 11523-7341), PACK(11523-7234, 11523-7341)
Establishment
NameAddressID/FEIBusiness Operations
PTI Royston LLC601006997MANUFACTURE(11523-7268, 11523-7234, 11523-7341, 11523-4357), PACK(11523-7268, 11523-7234, 11523-7341, 11523-4357)

Revised: 4/2014
 
MSD Consumer Care, Inc.

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