MiraLAX

MiraLAX is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements.

MiraLAX is used as a laxative to treat occasional constipation or irregular bowel movements.

MiraLAX may also be used for purposes not listed in this medication guide.

Use MiraLAX exactly as directed on the label, or as it has been prescribed by your doctor. Do not use this medicine in larger or smaller amounts or for longer than recommended.

To use MiraLAX powder, measure your dose with the medicine cap on the bottle. This cap should contain dose marks on the inside of it. Pour the powder into 4 to 8 ounces of a cold, hot, or room temperature beverage such as water, juice, soda, coffee, or tea. Do not combine with starch-based thickeners used for difficulty swallowing. Stir this mixture and ensure that the powder is fully dissolved before drinking. Do not drink if there are any clumps. Drink it right away. Do not save for later use.

MiraLAX should produce a bowel movement within 1 to 3 days of using the medication. Polyethylene glycol 3350 normally causes loose or even watery stools.

Do not use MiraLAX 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.

Store at room temperature away from moisture and heat.

You should not use MiraLAX if you have a bowel obstruction or intestinal blockage, or if you have kidney disease (unless your doctor tells you to). If you have any of these conditions, you could have dangerous or life-threatening side effects from MiraLAX.

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

Before taking MiraLAX, tell your doctor if you are allergic to any drugs, or if you have ulcerative colitis, irritable bowel syndrome, nausea or vomiting with severe stomach pain, or if you have had a sudden change in bowel habits that has lasted 2 weeks or longer.

MiraLAX should produce a bowel movement within 1 to 3 days of using the medication. Polyethylene glycol 3350 normally causes loose or even watery stools.

Do not use MiraLAX 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.

You should not use MiraLAX if you are allergic to polyethylene glycol, if you have a bowel obstruction or intestinal blockage, or if you have kidney disease (unless your doctor tells you to). 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; 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 MiraLAX 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.

Get emergency medical help if you have any signs of an allergic reaction to MiraLAX: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have:

• diarrhea (including severe or bloody diarrhea);
• rectal bleeding;
• blood in your stools; or
• nausea, bloating, cramping, or stomach pain that gets worse.

Common MiraLAX side effects may include:

• bloating, gas, upset stomach;
• dizziness; or
• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose of MiraLAX for Constipation:

17 g (diluted in 8 fluid ounces water, juice, soda or coffee) orally once a day

Usual Pediatric Dose for Bowel Preparation:

Occasional constipation: Children greater than 6 months of age: 0.5 to 1.5 g/kg daily (initial dose 0.5 g/kg; titrate to effect) Maximum dose: 17 g/day Fecal impaction: Children greater than 3 years of age: 1 to 1.5 g/kg daily for 3 days Maximum dose: 100 g daily Bowel preparation: Children greater than 2 years of age: 1.5 g/kg/day Maximum dose: 100 g daily

Usual Pediatric Dose of MiraLAX for Constipation -- Acute:

Occasional constipation: Children greater than 6 months of age: 0.5 to 1.5 g/kg daily (initial dose 0.5 g/kg; titrate to effect) Maximum dose: 17 g/day Fecal impaction: Children greater than 3 years of age: 1 to 1.5 g/kg daily for 3 days Maximum dose: 100 g daily Bowel preparation: Children greater than 2 years of age: 1.5 g/kg/day Maximum dose: 100 g daily

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Other drugs may interact with MiraLAX, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.