One of the top worries among parents is that their children will get sick, and when the winter flu and cold season hits, illnesses can pop up more frequently.

Yet over-the-counter children’s products on the market have received mixed reviews, including the negative publicity surrounding children’s cold and cough medicines when the Food and Drug Administration raised a red flag about the use of these products in children. Warnings such as this one likely cause concern and confusion among parents about what they can give to their children to treat illness safely and effectively.

Good News!

Homeopathic medicines offer parents safer option. In fact, homeopathic medicines are one of the safest choices for self-treatment. Why? These medicines

• do not contain any of the ingredients under question for use in children
• have no known side effects (not even drowsiness or jitteriness in children)
• don’t interact with other medication
• don’t mask symptoms (allowing doctors and patients to easily detect and respond to symptoms of serious illnesses should they arise)
• are not body-mass dependent (so there’s no need to give more or less medicine depending on body weight), and
• have no risk of overdose

Boiron’s New Medicines

For 65 years, families around the world have relied on Oscillococcinum to safely relieve flu-like symptoms. Now parents can find Children’s Oscillococcinum and Children’s Coldcalm for colds in the kid’s aisle along with Children’s Chestal cough syrup.

Each of these products contains active ingredients that are micro-doses of natural ingredients. They don’t contain any of the ingredients called into question by the FDA for use in children.

Parent-Friendly Products

All of Boiron’s products are regulated as drugs by the FDA¹ and are clearly labeled for specific indications, making directions easy for parents to understand. And, they are manufactured according to the highest standards.

Parents can quickly and affordably pick up these over-the-counter 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.

In today’s busy world, parents have a lot of concerns on their minds. Flu and cold medicines for their children shouldn’t be on that list.

^{1.U.S. Food and Drug Administration. Sec 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG7132.15). Available at: www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg400-400.html.}

Drug safety is always a top concern on the minds of consumers. Many medications often come with a list of side effects, some of which are bearable, some of which are not. Also, warnings about a drug’s safety can sometimes emerge long after that medicine has been on the market.

One example is the Food and Drug Administration’s public health advisory in 2007 about over-the-counter cough and cold medicines for children. A panel convened by the FDA recommended that the agency not allow drugs containing antihistamines, decongestants and cough suppressants to be used for infants and children younger than 2 years old. Human error leading to overdosing was a major concern, citing confusion with directions or accidentally giving the same ingredient when administering multiple products.

As the agency continues to review the safety of these drugs in children ages 2 through 11, manufacturers voluntarily relabeled the cold and cough medications in question instruction parents not to used them in children under 4 years of age.

Warnings such as this one aren’t taken lightly and often encourage consumers to be even more vigilant about which medicines they take. This increased vigilance drives consumers to do more research about safe new medicines.

A Homeopathic Solution

As we said above, the FDA is concerned about accidental misuse of these types of medications, leading to dangerous side effects in children. Homeopathic medicines, however, don’t contain any of the ingredients under question for use in small children.

These medicines also don’t interact with other medication.

Here’s another safety benefit of homeopathic medicines: They do not mask symptoms. As a result, doctors and patients can easily detect and respond to symptoms of serious illnesses if they are present.

Finally, a crucial safety advantage is that there’s no risk of overdose with homeopathic medicines.

All of these benefits make homeopathic medicines one of the safest choices for self-treatment.

Safe, Effective Children’s Medicines

Earlier in this post we mentioned the FDA’s advisory about children’s cough and cold medicines. The concern about these drugs leaves many parents wondering how to ease their children’s cold-related ailments, especially with the winter cold season upon us.

Boiron has created Children’s Oscillococcinum for flu-like symptoms and Children’s Coldcalm Pellets for colds. Parents will be able to more easily find these safe and reliable over-the-counter medicines in the children’s aisle along with Boiron’s established Children’s Chestal for coughs.

These homeopathic flu, cold and cough medicines do not contain any of the ingredients under question for use in children. Their active ingredients are micro-doses of natural ingredients.

Making It Easy for Parents

All of Boiron’s products are regulated as drugs by the FDA¹ and are clearly labeled for specific indications, making directions easy for parents to understand.

Not only that, parents can quickly and affordably pick up these over-the-counter 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.

^{1.U.S. Food and Drug Administration. Sec 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG7132.15). Available at: www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg400-400.html.}

What is the FDA?

The FDA, or Food and Drug Administration, is the U.S. government agency responsible for protecting the health of the public by assuring the safety, efficacy and security of human and veterinary drugs as well as biological products, medical devices, food and more.

As part of this effort, the organization works to speed up the innovations that make medicines and foods more effective, safer and more affordable.

The agency also works to help the public get accurate, science-based information on these medicines and food so that people can make wise decisions about their health.

Homeopathic Medicines and the FDA

The FDA regulates the manufacturing, labeling, marketing and sales of homeopathic medicines. Homeopathic medicines have been regulated as drugs by the FDA since the federal Food, Drug, and Cosmetic Act was passed in 1938.¹ Being regulated as drugs instead of as food or dietary supplements is an important distinction—more on that shortly.

So what does the FDA require for a medicine homeopathic to go to market?

To be accepted as a homeopathic medicine by the FDA, the product must contain ingredients that are identified in the Homeopathic Pharmacopoeia of the United States (HPUS) or that are accepted as homeopathic under the principles of homeopathy.

To be included in the HPUS, which has been in continuous publication since 1897, a homeopathic drug must be determined safe and effective, must be prepared according to the specifications set forth in the HPUS, and the drug’s benefits must be established in one of the following ways: through clinical verification; published documentation that the substance was in use prior to 1962; through two adequately controlled double-blind clinical studies; or though data gathered from clinical experience that encompasses the symptom picture before and after treatment.

Look for the HPUS Acronym

All of Boiron’s homeopathic medicines are manufactured according to the highest standards, complying with specifications of HPUS as well as drug Good Manufacturing Practices, which require that manufacturers take proactive steps to ensure that their products are safe, pure and effective.

Drug Labeling

As we said earlier, the FDA regulates homeopathic medicines as drugs, as opposed to food or dietary supplements. This type of regulation ensures that homeopathic medicines adhere to drug labeling specifications.

Like packaging for over-the-counter drugs, the packaging for homeopathic medicines must include the:

• specific diseases, ailments or symptoms for which the product is to be used,
• concentration of the active substance or substances contained in the product,
• recommended dosage,
• directions for use, and
• warnings

The FDA oversight of homeopathic medicine means clear specifications on product packaging, making choices easier for consumers and guidance easier for retailers.

Add to that an adherence to the highest standards, and you’ve got a line of top-quality medicines at Boiron.
^{1.U.S. Food and Drug Administration. Sec 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG7132.15). Available at: www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg400-400.html.}