A white powder for reconstitution. MiraLax (polyethylene glycol 3350, NF) is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C₂H₄O)_n H in which n represents the average number of oxyethylene groups. Below 55º C it is a free flowing white powder freely soluble in water.

MiraLax is an osmotic agent for the treatment of constipation.

For the treatment of occasional constipation (irregularity). This product should be used for 7 days or less or as directed by a physician.

The usual dose is 17 grams (about 1 heaping tablespoon) of powder per day (or as directed by physician) in 4 to 8 ounces of water. Each bottle of MiraLax is supplied with a measuring cap marked to contain 17 grams of laxative powder when filled to the indicated line. One to 3 days (24 to 72 hours) may be required to produce a bowel movement.

Directions

• 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 (17g)
• 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

In powdered form, for oral administration after dissolution in water. MiraLax is available in two sizes; a 8.3 oz. container and a 4.1 oz. container of laxative powder.

The cap on each bottle is marked with a measuring line and may be used to measure a single MiraLax dose of 17 grams (about 1 heaping tablespoon).

STORAGE

Store at 20° - 25°C (68° - 77°F)

Tamper-evident:do not use if foil seal under cap is missing, open or broken.

© 2007, Schering-Plough HealthCare Products, Inc. 1-800-MiraLAX (1-800-647-2529). *Use as directed.

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients. Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.

No specific drug interactions have been demonstrated.

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 /li>

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 your nausea, bloating, 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

There have been no reports of accidental overdosage. In the event of overdosage diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered.

MiraLax is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

Pharmacology: MiraLax is as osmotic agent which causes water to be retained with the stool.

CLINICAL TRIALS

There have been several key clinical studies involving MiraLAX.

Reference 1

Efficacy and Safety of Traditional Medical Therapies for Chronic Constipation: Systematic Review.

Ramkumar D et al. Am J Gastroenterol. 2005;100:936-971.

• The results of 37 years of clinical trials evaluating the safety and efficacy of laxatives were studied and compared to make guideline recommendations for their use
• The best evidence found supports the use of polyethylene glycol (MiraLAX) and tegaserod
• Considerable evidence also supported the use of psyllium and lactulose

Study 1

New Polyethylene Glycol Laxative for Treatment of Constipation in Adults: A Randomized, Double-Blind, Placebo-Controlled Study.

Cleveland MV et al. South Med J. 2001;94:478-481.

• Evaluated the safety and effectiveness of MiraLAX in people with constipation
• 23 patients with constipation were given the normal daily dose (17 grams) of MiraLAX or a placebo and were watched for any changes in how often they had bowel movements
• After 14 days, patients given MiraLAX had significantly (P=.0001) more bowel movements than those on placebo, and they had no serious side effects

Study 2

An Efficacy and Consumer Preference Study of Polyethylene Glycol 3350 for the Treatment of Constipation in Regular Laxative Users.

Data on File.

• 74 patients with constipation used MiraLAX instead of their usual laxative for up to 2 weeks
• Number of bowel movements nearly doubled with MiraLAX, while there was less complaint of gas and bloating
• More than two thirds of patients in this study preferred MiraLAX to their usual laxative

Study 3

A Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of a New Polyethylene Glycol Laxative.

DiPalma JA et al. Am J Gastroenterol. 2000;95:446-450.

• Evaluated the safety and effectiveness of MiraLAX in 151 people with constipation
• Patients were given either MiraLAX or a placebo, and kept track of any changes in how often they had bowel movements as well as changes to the bowel movement itself
• After 2 weeks, patients who took MiraLAX had significantly (P<.001) more bowel movements than those who were given a placebo, and also had less cramping and gas

Study 4

Braintree Polyethylene Glycol (PEG) Laxative for Ambulatory and Long-Term Care Facility Constipation Patients.

DiPalma JA et al. Online Journal of Digestive Health. 1999;1(2).

• Evaluated the safety and effectiveness of MiraLAX in 50 people with constipation who were either ambulatory outpatients or living in long-term care facilities
• Patients received placebo or a high (34 grams) or low (17 grams) dose of MiraLAX (later reduced to 12 and 6 grams, respectively, in long-term care patients)
• All patients given MiraLAX had increases in how often they had bowel movements and improvement in the quality of the bowel movement, with no severe side effects
• The higher doses of MiraLAX yielded better bowel movements more often versus lower doses, and people given either dose of MiraLAX had better outcomes than those on placebo

MiraLax softens the stool and increases the frequency of bowel movements by retaining water in the stool. It should always be taken by mouth after being dissolved in 8 ounces of water, juice, soda, coffee, or tea. Should unusual cramps, bloating, or diarrhea occur, consult your physician.

One to 3 days may be required to produce a bowel movement. This product should be used for 7 days or less or as directed by a physician. Prolonged, frequent or excessive use of MiraLax may result in electrolyte imbalance and dependence on laxatives.

Frequently Asked Questions

Q: What is MiraLAX?
A: MiraLAX (Polyethylene Glycol 3350) is a new kind of OTC laxative. It is safe and effective* and treats constipation by working with your body to restore its natural rhythm. MiraLAX is the #1 prescribed laxative (it has been the #1 choice of doctors for years), and MiraLAX is the first prescription laxative in more than 30 years to be made available OTC.

Q: Do I need a prescription for MiraLAX?
A: No. While you once needed a prescription to get MiraLAX, it's now available direct to you wherever laxatives are sold.

Q: How does MiraLAX work?
A: MiraLAX is different from all other OTC laxatives and it works with your body to relieve constipation. MiraLAX restores your natural rhythm by using the body's own water to gently increase the frequency of bowel movements and to soften the stool so it is easier to pass. With MiraLAX you can control the urge to go.

Q: How do I take MiraLAX?
A: MiraLAX is taken once daily. Each bottle has a white dose-measure built into the cap. MiraLAX dissolves easily and completely (no grit) when you stir the powder into any everyday beverage (4-8 oz), such as water, juice, soda, coffee or tea.

Q: Does MiraLAX cause cramps or gas?
A: No. Relief with MiraLAX is a normal, easy and complete bowel movement. As it works it provides more comfort and less straining and without the harsh side effects of cramps or gas. In fact, MiraLAX actually reduces the cramps and gas that may be caused by constipation.

Q: How common is constipation?
A: Very common. More than 65 million people-that's about 1 in 4 people-suffer the discomfort of constipation in the United States alone.

Q: What is constipation?
A: Constipation occurs when a person's bowel movements become difficult or when they happen less frequently than normal.

Q: How often do most people have a bowel movement?
A: Normal frequency is different for everyone. Some people go once or twice a day, others three times a week-all completely normal if that number of trips to the bathroom is the regular routine.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

POLYETHYLENE GLYCOL (PEG) 3350 - ORAL

(paw-lee-ETH-ih-leen GLY-coll)

COMMON BRAND NAME(S): Miralax

USES: This medication is used to treat occasional constipation. It works by holding water in the stool to soften the stool and increases the number of bowel movements. It is known as an osmotic-type laxative.

This medication is also available without a prescription. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

HOW TO USE: Take by mouth usually once daily, or as directed by your doctor or the directions on the product package.

If you are prescribed the individual packets, mix the powder as directed by your doctor or pharmacist. If you are using the bulk bottle, use the provided cap to measure the prescribed dose. Mix the powder with a full glass (8 ounces or 240 milliliters) of liquid such as water, juice, soda, coffee, or tea. Before drinking the solution, stir the powder well until it completely dissolves. If you have any questions, ask your pharmacist.

It may take 2 to 4 days after you have started this medication to have a bowel movement. Do not increase your dose or take it more frequently than prescribed. Also, do not use this medication for more than 2 weeks unless directed by your doctor. Tell your doctor if your condition persists or worsens. Extended use or overuse may result in dependence on laxatives and chronic constipation. Overuse may cause diarrhea, excess loss of body water (dehydration), and mineral imbalance (e.g., low sodium).

If you are using nonprescription polyethylene glycol for self-treatment of occasional constipation and this treatment has not worked after 7 days, talk to your doctor for additional treatment advice.

SIDE EFFECTS: Nausea, abdominal cramping, or gas may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Inform your doctor immediately if you have excessive number of bowel movements, persistent diarrhea, or rectal bleeding while using this medication.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to polyethylene glycol; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain stomach/intestinal problems (bowel obstruction).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: persistent nausea/vomiting/abdominal pain, other stomach/intestinal problems (irritable bowel syndrome), kidney disease.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially diarrhea.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: If you are using this medication under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any other medicine you are using before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe diarrhea, dizziness, decrease in the amount of urine.

NOTES: Do not share this medication with others.

To prevent constipation, remember to exercise regularly, drink adequate fluids, and eat fiber-rich foods such as bran, whole grain, fresh fruits, and vegetables. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. See packaging for the exact temperature range. If you have any questions about storage, ask your pharmacist. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.