Teething Tablet Safety Information

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FACT SHEET

Updated: September 24, 2010

Hyland's Teething Tablets Safety Information

As a manufacturer of homeopathic medicines, and as parents ourselves, we want to share with you how Hyland’s Teething Tablets are made and what they contain to effectively and safely alleviate your child’s teething aches and pains.

First and foremost, homeopathic medicines are regulated as drugs by the Food and Drug Administration (FDA), as required in the Food, Drug and Cosmetic Act. The production of Hyland’s homeopathic medicines occurs within a validated process, as with any FDA-regulated drug, to ensure an accepted level of consistency in product output.

Hyland’s Teething Tablets contain homeopathically prepared forms of Calcarea Phosphorica, Chamomilla, Coffea Cruda, and Belladonna. These ingredients are all prepared in accordance with the Homeopathic Pharmacopœia of the United States (HPUS). HPUS has been recognized by the FDA since 1938 as the official compendium (or formula book) for homeopathic medicine in the U.S. When homeopathically prepared, active ingredients are diluted to the point that the risk of toxicity is extremely low (see specific details below).

Calcarea Phosphorica is included in Hyland’s Teething Tablets for its ability to support teeth formation. Chamomilla is included in the Tablets for its actions on irritability commonly associated with teething pain. Coffea Cruda is included in the Tablets for its actions on wakefulness and increased urination.

Belladonna is included in the Tablets to ease the redness, inflammation and discomfort of the child’s gum that often occurs during the teething process. Belladonna 3X HPUS is manufactured from the whole plant, of which a small portion is Belladonna alkaloids (the component sometimes associated with side effects). Each Teething Tablet (which weighs about 65 mg) is composed of 0.0003% Belladonna alkaloids as stated on the label. This means that each complete teething tablet contains only approximately 0.0002 mg of Belladonna alkaloids.

The amount of Belladonna alkaloids in teething tablets is minuscule, especially when compared to conventional medicine. Conventional medicines typically use 0.2 to 5 mg of Belladonna alkaloids per tablet as an anti-spasmodic – roughly 1,000 to 25,000 times larger than the quantities used in Hyland’s Teething Tablets. The side effects sometimes caused by conventional medicines delivering more than 0.2 mg of Belladonna alkaloids – such as dry mouth, blurred vision and urinary retention – are not associated with homeopathic medicines because of their minute dosage.

To put homeopathic dosages in perspective, typically a 10-pound child would need to ingest 1,000 Hyland’s Teething Tablets (at least 6 bottles of 125 tablets) to exhibit even the first possible side effect of Belladonna.

Hyland’s Teething Tablets have been safely used by millions of children since being introduced to the U.S. market in 1945!

We care about your child and our consumers’ safety is our #1 priority. For that reason, we have pharmacists available around the clock (24 hours per day, 7 days per week) to provide emergency information related to any of our products. You can contact us at 1-800-624-9659 (number also available on all packaging). We are confident that our pharmacist can help parents and their doctors reach informed conclusions regarding our products.

Please keep in mind that even if a child ate an entire bottle of homeopathic medicine, the minute amount of active ingredients renders an overdose unlikely. Nonetheless, we understand that parents are rightfully cautious about their own child so feel free to call us anytime if you are concerned.

While adverse symptoms that may be attributed to an overdose of Belladonna alkaloids are well documented in the literature, the concentration necessary would require the ingestion of multiple bottles of Teething Tablets. As this is very unlikely, such symptoms could be due to any of a number of other causes (click here for more causes that could be explored).

We at Hyland’s, Inc. greatly value our relationship with the consumers who make up our Hyland’s family. Please do not hesitate to call 1-800-624-9659 and ask for our on-staff pharmacist to receive any additional information.

Iris R. Bell, MD PhD

Director of Scientific Affairs