Wednesday, September 14, 2016

MiraLAX




Generic Name: polyethylene glycol 3350

Dosage Form: powder, for solution
MiraLAX®

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

Drug Facts



Active ingredient (in each dose)


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


  • 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 is open or broken


Inactive ingredients


none



Questions or comments?


1-800-MiraLAX (1-800-647-2529) or www.MiraLAX



PRINCIPAL DISPLAY PANEL - 17g Packet Carton


10 Packets


NDC 11523-7268-3


Original

Prescription

Strength


MiraLAX®

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative


NeatPAX™

Travel Size


  • Relieves Occasional

    Constipation

    (Irregularity)

  • Softens Stool

10 PACKETS

EACH PACKET NET WT 0.5 OZ (17g)


10

ONCE-DAILY DOSES










MiraLAX 
polyethylene glycol 3350  powder, for solution










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)11523-7268
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350)Polyethylene Glycol 335017 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITE (Colorless upon dissolution)Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
111523-7268-310 PACKET In 1 CARTONcontains a PACKET
11 DOSE PACK In 1 PACKETThis package is contained within the CARTON (11523-7268-3)
211523-7268-824 PACKET In 1 CARTONcontains a PACKET
21 DOSE PACK In 1 PACKETThis package is contained within the CARTON (11523-7268-8)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201502/23/2009


Labeler - Schering-Plough HealthCare Products, Inc. (039137567)









Establishment
NameAddressID/FEIOperations
Schering Corporation155914674MANUFACTURE









Establishment
NameAddressID/FEIOperations
Catalent Pharma Solutions806746405PACK, LABEL
Revised: 07/2010Schering-Plough HealthCare Products, Inc.




More MiraLAX resources


  • MiraLAX Side Effects (in more detail)
  • MiraLAX Use in Pregnancy & Breastfeeding
  • MiraLAX Drug Interactions
  • MiraLAX Support Group
  • 27 Reviews for MiraLAX - Add your own review/rating


  • MiraLax Concise Consumer Information (Cerner Multum)

  • MiraLax Powder for Oral Solution MedFacts Consumer Leaflet (Wolters Kluwer)



Compare MiraLAX with other medications


  • Bowel Preparation
  • Constipation
  • Constipation, Acute

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