FDA Label for Miralax

Other

Drug Facts

Active Ingredient (In Each Dose) (Bottle Only)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

Osmotic Laxative

Osmotic Laxative

Active Ingredient (In Each Dose) (Packet Only)

Polyethylene Glycol 3350, 17 g

Use

• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 1 to 3 days

Allergy Alert

Do not use if you are allergic to polyethylene glycol

Otc - Do Not Use

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

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

Otc - When Using

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

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

Otc - Keep Out Of Reach Of Children

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

1 - label