From Pharmacy Drug Guide
The recall was due to caps that may not be properly fitted to the bottle, possibly causing a choking risk to children as well as allowing contamination of the package contents. No issues were reported regarding the safety or effectiveness of the medication inside the containers.
MiraLax® is an over-the-counter drug containing the active ingredient polyethylene glycol. It is indicated for relief of occasional constipation, and most users will experience a bowel movement within one to three days of taking MiraLax®.
Wikimedia Commons: Klaus Hoffmeier
|Date of initial recall||July 15, 2010|
|Attained over the counter status||October 6, 2006|
|Treats||Occasional constipation, irregular bowel movements|
|Reason for recall||Ill-fitting cap is not correctly resealable|
|Disclaimer||The information provided by PharmacyDrugGuide is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.|
MiraLax® is a laxative powder containing polyethylene glycol that is mixed with liquid. It works to increase the amount of water in the intestinal tract to stimulate bowel movements. MiraLax® is primarily used to treat occasional constipation and irregular bowel movements. It is an osmotic laxative, which the company claims has fewer side effects than other types, such as bulk-forming laxatives, stimulant laxatives, lubricants, and saline laxatives. MiraLax® is sold in packages of 7, 14 or 30 doses, as well as in packs of 10 single-dose packets.
Patients are directed to use the medicine cap on the bottle to measure the indicated dosage using the marks on the inside of the cap. The powder may be poured into a four-to-eight-ounce serving of a beverage, e.g., juice, water, soda, coffee, or tea. Users then stir the mixture and drink immediately. Consumers are advised not save any of the unused mixture for consumption at a later time.
Signs of constipation include less-frequent bowel movements, difficulty passing stool, or stool that is hard and lumpy. Common causes of constipation include lack of fiber in the diet, dehydration, lack of exercise, medical conditions and certain medications. MiraLax® not only works to treat constipation, but also softens stool.
The two MiraLax® products that were recalled on July 15, 2010, by Schering Plough were 17.9-ounce MiraLax® Laxative Powder 30-day dose with UPC code 4110082071 and 19.9-ounce MiraLax® Laxative Powder 30 day dose 4 ct sachet with UPC code 4110080770. The phone number for additional information about the recalled products is 800-647-2529.
MiraLax Side Effects
One of the selling points of MiraLax® is that, according to the manufacturer, it causes fewer side effects than other products such as bulk-forming laxatives, stimulant laxatives, lubricants and saline laxatives. However, some users experience adverse reactions to MiraLax®. Some of the more common side effects of MiraLax® include gas, upset stomach and abdominal cramps. In rare cases, severe or medically dangerous side effects can occur such as the following:
- Diarrhea that does not subside
- Bleeding of the rectum
- An unusually high number of bowel movements
It is also possible, though rare, to experience severe allergies to MiraLax®. Symptoms may include swelling, itching and/or breathing trouble. Patients with questions regarding MiraLax® may contact the manufacturer at 800-MiraLAX, or 800-647-2529.
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