PHILADELPHIA, Oct. 3 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) reopened discussions on Oct. 2 regarding the human error risks of dispensing decongestants, antihistamines and cough suppressants to children, and if these risks are proportional to the estimated benefits for children based on using a fraction of doses shown to relieve symptoms in adults.
In response to the agency's determination that it was "uncomfortable" with these risks last October, Boiron, world leader in homeopathy, is launching Children's Oscillococcinum(R) for flu-like symptoms and Children's Coldcalm(R) for colds. Parents wondering how to ease their children's winter woes will more easily be able to find these safe and reliable over-the-counter (OTC) medicines in the children's aisle along with Boiron's established Children's Chestal(R) for coughs.
These homeopathic medicines do not contain any of the ingredients under question for use in youngsters. Their active ingredients are micro-doses of natural ingredients. Since homeopathic medicines are not body-mass dependent, there's no need to give more or less medicine depending on body weight. There's no risk of overdose or interaction with other medications in case parents decided to administer a cold medicine on top of cough syrup. Nor are there reported side effects such as making children jittery or drowsy. In general, homeopathic medicines are considered one of the safest choices for self-treatment.
Rather than "mask" symptoms that may indicate a more serious condition, these medicines work with the body by sending it a signal to help rebalance itself and heal. For example, a cough suppressant works against the body, but a homeopathic cough syrup like Children's Chestal acts as an expectorant."
New packaging for Children's Oscillococcinum and Children's Coldcalm highlights the sweet-tasting, kid-friendly pellets that dissolve under the tongue. No water, chewing or swallowing is required.
Children's Oscillococcinum should be taken at the first sign of feeling achy or run-down to nip flu-like symptoms in the bud. Containing 6 doses to be given in 6-hour intervals as necessary, Children's Oscillococcinum is expected to retail for $11.99. It is safe for children 2 years of age and older.
While many cold medicines treat only a symptom or two, Children's Coldcalm is a complete multi-symptom cold reliever for sneezing, runny nose, nasal congestion and minor sore throat pain. To be taken in 2-hour intervals as necessary, the 32-dose unit of Children's Coldcalm is expected to retail for $9.99 and is safe for children 3 years of age and older.
Both are from Boiron, maker of Oscillococcinum(R), which has been relied upon by families around the world for more than 65 years. All Boiron products are regulated as drugs by the FDA(1) and are clearly labeled for specific indications, making directions easy for parents to understand. They are manufactured according to the highest standards, complying with drug Good Manufacturing Practices (GMPs) and the Homeopathic Pharmacopoeia of the United States (HPUS).
Parents can now quickly and affordably pick up these OTC medicines without a prescription in the children's aisle or in the cough, cold and flu section of health food stores and independent pharmacies nationwide. For more information, visit http://www.boironusa.com.
1. U.S. Food and Drug Administration. Sec 400.400 Conditions Under
Which Homeopathic Drugs May be Marketed (CPG7132.15). Available at:
Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Christophe Merville http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=56842
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