MiraLax

Name: MiraLax

Description

Active Ingredient (in each dose) (Packet Only)

Polyethylene Glycol 3350, 17 g

Inactive Ingredients

none

Indications

Purpose

Osmotic Laxative

Use

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

Patient information

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 or 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.

What is the most important information I should know about polyethylene glycol 3350?

You should not use this medicine if you have a bowel obstruction or intestinal blockage. If you have any of these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol 3350.

Do not use polyethylene glycol 3350 more than once per day. Call your doctor if you are still constipated or irregular after using this medication for 7 days in a row.

What should I discuss with my healthcare provider before taking polyethylene glycol 3350?

You should not use this medicine if you are allergic to polyethylene glycol, or if you have a bowel obstruction or intestinal blockage. If you have any of these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol 3350.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

To make sure this medicine is safe for you, tell your doctor if you have:

  • nausea, vomiting, or severe stomach pain;

  • ulcerative colitis;

  • irritable bowel syndrome;

  • kidney disease; or

  • if you have had a sudden change in bowel habits that has lasted 2 weeks or longer.

FDA pregnancy category C. It is not known whether polyethylene glycol 3350 will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether polyethylene glycol 3350 passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Inactive ingredients

none

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 Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7268
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) Polyethylene Glycol 3350 17 g
Product Characteristics
Color WHITE (Colorless upon dissolution) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:11523-7268-3 10 PACKET (PACKET) in 1 CARTON
1 1 POWDER, FOR SOLUTION (DOSE PACK) in 1 PACKET
2 NDC:11523-7268-8 24 PACKET (PACKET) in 1 CARTON
2 1 POWDER, FOR SOLUTION (DOSE PACK) in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022015 02/23/2009
Labeler - Schering-Plough HealthCare Products, Inc. (039137567)
Establishment
Name Address ID/FEI Operations
Schering Corporation 155914674 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions 806746405 PACK, LABEL
Revised: 07/2010   Schering-Plough HealthCare Products, Inc.

What should I avoid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

For the Consumer

Applies to polyethylene glycol 3350: oral packet, oral powder

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Belly pain.
  • Stomach cramps.
  • Gas.
  • Bloating.
  • Upset stomach.
  • More frequent stools.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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