Miralax powder, for solution

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

Otc - do not use section

Do not useif 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

Otc - ask doctor/pharmacist section

Ask a doctor of pharmacist before use if you aretaking a prescription drug

Otc - when using section

When using this productyou 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

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,ask a health professional before use.

Otc - keep out of reach of children section

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 20-25C (68-77F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive ingredients

none

Ingredients and appearance - Product information

Miralax powder, for solution- Polyethylene glycol 3350

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Polyethylene glycol 3350 ( UNII: G2M7P15E5P)( Polyethylene glycol 3350 - UNII: G2M7P15E5P ) 17 gin 17 g

Product Characteristics

Color white (Colorless upon dissolution)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA022015 USA

Miralax powder, for solution- Polyethylene glycol 3350

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11523-7234
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Polyethylene glycol 3350 ( UNII: G2M7P15E5P)( Polyethylene glycol 3350 - UNII: G2M7P15E5P ) 17 gin 17 g

Product Characteristics

Color white (Colorless upon dissolution)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA022015 USA 2007/02/01

Miralax powder, for solution- Polyethylene glycol 3350

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11523-7341
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Polyethylene glycol 3350 ( UNII: G2M7P15E5P)( Polyethylene glycol 3350 - UNII: G2M7P15E5P ) 17 gin 17 g

Product Characteristics

Color white (Colorless upon dissolution)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA022015 USA 2007/02/01

Miralax powder, for solution- Polyethylene glycol 3350

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11523-4357
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Polyethylene glycol 3350 ( UNII: G2M7P15E5P)( Polyethylene glycol 3350 - UNII: G2M7P15E5P ) 17 gin 17 g

Product Characteristics

Color white (colorless upon dissolution)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA022015 USA 2007/02/01

Labeler - Bayer HealthCare LLC.( 112117283)