Frequently
Asked Questions

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General Questions

When do babies start to teethe?

All babies start to teethe at different times and for different durations – unfortunately, there is no set pattern. Teething usually begins around 6 months of age, but it is normal for teething to start at any time between 3 months and 12 months of age. By the time your child is about 3 years old, s/he will have all 20 primary teeth. (http://children.webmd.com/tc/teething-topic-overview)

How can I tell that my baby is teething?

The symptoms of teething vary from child to child. A teething baby may experience any of the following symptoms: irritability, drooling, chin rash, biting and gnawing, diarrhea, low-grade fever, and wakefulness at night – or none at all. Check with your doctor if you are unsure if your child is showing symptoms of teething.


How to Use Hyland’s Baby Teething Products

At what age can I give my baby Hyland’s Baby Teething Tablets and Teething Gel?

Hyland’s Baby Teething Tablets and Teething Gel are formulated for babies of all ages – starting with infants. You can safely give your child these medicines at any age.

What is the difference between Hyland’s Baby Teething Tablets and Teething Gel?

Hyland’s Baby Teething Tablets and Teething Gel are two different dosage forms that share the same active ingredients. Hyland’s Baby Teething Tablets are quick-dissolving tablets that melt instantly in a baby’s mouth upon contact with saliva. Hyland’s Baby Teething Gel is administered directly to the gums for on-the-spot relief of teething pain.

Can I give my baby these products along with Tylenol or Motrin?

From Dr. Iris Bell, Hyland’s Medical Director: Past research suggests that homeopathic medicines generally have low rates of adverse events in comparison with conventional medications and herbal supplements. However, avoid using Hyland’s Baby Teething Tablets if your child is extremely allergic to any ingredient in the product. While Hyland’s Baby Teething Tablets can be taken safely with other medications, please note that many other medications may have side effects.

How quickly do they work?

Each child will react differently to the tablets; some will receive immediate relief, while it can take longer for other babies to experience relief. We recommend that you give your child 2 to 3 tablets under the tongue or in a teaspoon of water, 4 times per day. If the child is restless or wakeful, give 2 tablets every hour for 6 hours. If, after 24-48 hours, you do not see a change in your child, discontinue use and seek another product or the advice of a licensed health care provider.

My baby fell asleep – are Hyland’s Baby teething products sedatives?

No, Hyland’s Baby teething products contain no sedatives. Children often fall asleep after using these teething products because their pain has been relieved and after much crying or being upset, they can finally rest and sleep.

What do they taste like?

Hyland’s Baby Teething Tablets and Teething Gel have no added flavorings. Most people report that they taste faintly sweet.


Using Hyland’s Baby Teething Tablets

How many tablets do I give my child? Is the number of tablets age-or weight-dependent?

As with all medications, you should read and follow label instructions. Dissolve 2 to 3 tablets under the tongue or in a teaspoon of water, 4 times per day. If the child is restless or wakeful, give 2 tablets every hour for 6 doses or as recommended by a licensed health care practitioner.

Unlike other medicines, the dosing for Hyland’s teething medications is not dependent on a child’s age or weight. Dosing is the same for babies and children of all ages.

How often can I give the tablets to my child?

In acute cases of teething pain, you can give your child 2 to 3 tablets for up to 6 doses per day or as recommended by a licensed health care practitioner. If you do not see improvement within 24-48 hours, stop giving the tablets and consult a licensed health care professional.

What is the risk of overdosing?

From Dr. Iris Bell, Hyland’s Medical Director: We have added child- resistant caps to Hyland’s Baby Teething Tablets to make it harder for children to accidentally dose themselves. Additionally, with the prior formula, a 10-pound child would need to have ingested at least six bottles of 125 Teething Tablets at once before experiencing the first mild side effect of dry mouth. Today, a child would have to ingest, at the same time, more than a dozen bottles of 135 Teething Tablets before experiencing dry mouth from the product. The body clears Belladonna alkaloids from any dose in a matter of hours (it is unlikely to build up in the system when taken as directed on the package label).

How do I give the tablets to my child?

Hyland’s Baby Teething Tablets are small, “soft” tablets that dissolve instantly in the mouth upon contact with saliva. You just need to put the tablets in your child’s mouth and they will dissolve. If you are uncomfortable with putting the tablets in your child’s mouth, the tablets may first be dissolved in a teaspoonful of water and then given to the child.

Won’t my baby choke on the tablets?

No, Hyland’s Baby Teething Tablets dissolve instantly upon contact with saliva, so there is no choking hazard at all with the tablets. You may wish to give your child a sip of water to assure the mouth is moist before giving them the tablets.

Do the Teething Tablets expire?

No, they don’t expire, and we don’t put expiration dates on the products, as they have been exempted from expiration dating guidelines by the FDA (CFR 211.137). The numbers that are imprinted on the edge of the labels are lot numbers – so we know exactly when the product was produced. We can track any product we made using that number.

Why is there white powder in my bottle of Hyland’s Baby teething tablets?

Because the tablets are soft and quick dissolving, it is normal for them to crumble a little during shipping, resulting in some powder in the bottle. As a precaution, please don’t let your baby turn the bottle into a rattle (contrary to our Shake Shake music video) – this breaks the tablets and creates more powder.

My tablets are discolored with grey or black spots that look like mold.

It appears that the bottle of Hyland’s tablets that you have has become moldy. If the homeopathic tablets have become moldy, it means that moisture and mold spores have somehow entered into the bottle of tablets. DO NOT use that bottle of tablets. In the future, you should not touch the tablets or put them back into bottle once they have been removed. We do not use preservatives in our tablets, so touching them could contaminate them with bacteria, mold or other microorganisms. When administering the tablets, it is best to shake the tablets into the bottle cap, and then tip them directly into your mouth without touching the cap to your mouth in order to avoid introducing saliva into the cap or bottle. Also, the tablets should be stored in a cool, dry place, away from any excessive heat or moisture. A bathroom, because of its moist environment, would not be a good place to store Hyland’s homeopathic tablets. If the tablets are discolored upon the first opening of the bottle, please call Hyland’s customer service at 800-624-9659.


Using Hyland’s Baby Teething Gel

How do I give my child Hyland’s Baby Teething Gel?

Wash hands before applying. For children of all ages, apply ¼” ribbon of Hyland’s Baby Teething Gel on your finger and carefully rub onto child’s gum every 15 minutes as needed. If symptoms persist for more than seven days or worsen, discontinue use and contact your health care provider.

How often can I give my child Hyland’s Baby Teething Gel?

For acute teething pain, apply Teething Gel every 15 minutes until symptoms decrease.

What is the risk of overdosing on Hyland’s Baby Teething Gel?

There is very little risk of overdosing. Hyland’s Baby Teething Gel contains the homeopathic medicine Belladonna, which is used to treat inflammation on the gum. Belladonna is used by conventional medicine in a very different form, in much larger doses, and can have significant side effects, requiring the medicine to be dispensed by prescription. Conventional medicine extracts the “Belladonna alkaloids” from the plant rather than using the whole plant, and uses the alkaloids in doses of 0.5 to 2.0 mg as an antispasmodic. In Hyland’s Teething Gel the pure Belladonna whole plant is diluted by a ration of 1:10, 12 times serially in order to prepare the Teething Gel, so the amount of Belladonna whole plant is very small (less that 1 part per billion). This compares to the 0.000000045 mg Belladonna alkaloid in an entire ½ oz. tube of Teething Gel, which gives it a large margin of safety.

Does Hyland’s Baby Teething Gel contain parabens?

No.


Formula

Do Hyland’s Baby Teething Tablets and Teething Gel contain benzocaine? Do they numb the gums?

No, neither Hyland’s Baby Teething Tablets nor Teething Gel contain Benzocaine, the common ingredient used to numb gums in conventional teething gels. Instead, they contain all-natural homeopathic medicines that work with the body to relieve the symptoms of teething pain in children — without numbing anything.

In April 2011, FDA issued a warning against using Benzocaine teething gels in children under 2, except under the advice and supervision of a healthcare professional. This is because benzocaine teething medications are associated with a rare but serious disease called methemoglobinemia (http://www.fda.gov/ drugs/drugsafety/ucm250024.htm).

What’s in the tablets and gel that makes them work?

Hyland’s Baby Teething Tablets and Teething Gel contain the following active medicines for the relief of the symptoms of teething pain:

  • Calcarea Phosphorica (a mineral) that supports dentition (teething)
  • Chamomilla (a botanical) relieves the symptoms of irritability
  • Coffea Cruda (a botanical) relieves the symptoms of sleeplessness
  • Belladonna (a botanical) relieves the symptoms of redness and inflammation of the gums

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.

Why do Hyland’s Baby Teething Tablets contain Coffea?

Homeopathic Coffea has been shown to reduce irritability in teething children. Since most children who are teething suffer from wakefulness and irritability, this component in Hyland’s Baby Teething Tablets has offered symptomatic relief to millions of children over the past 85 years.

Are the tablets and gel sugar free?

Both Hyland’s Baby Teething Tablets and Hyland’s Baby Teething Gel are free from table sugar, also known as sucrose. The tablets taste faintly sweet because they contain lactose, which is milk sugar. Hyland’s Baby Teething Gel is completely lactose-free.

Does Hyland’s Baby Teething Gel contain parabens?

No.


Dairy & Lactose Intolerance, Other Allergies

I don’t know if my baby is dairy intolerant. Is that a problem with Hyland’s teething products?

No. The inactive ingredient in Hyland’s Baby Teething Tablets, “Lactose N.F.” (stands for “National Formulary”), is a pharmaceutical grade lactose. While it is formulated from cow’s milk, it is completely purified of milk proteins, making it safe for lactose intolerant and dairy allergic people, including infants and children.

People who are lactose intolerant have not yet developed the enzymes to digest lactose. Our products contain about 64 milligrams of lactose (the sugar from cow’s milk – no protein is used) per tablet. While everyone is different, most lactose intolerant individuals need to ingest 5000 mg of lactose before they experience symptoms of intolerance. With this large margin of safety, there is rarely a problem with our products when being used as directed on the label. If your physician has determined that you are specifically “Allergic to Lactose”, you should avoid our tablets. If you are very concerned, seek the advice of a licensed health care professional before using this product.

Hyland’s Baby Teething Gel is completely lactose-free.

I thought you can’t give milk to babies until they are 1 year old. How can I give them lactose-based tablets?

The lactose base is a milk sugar, and not the proteins found in dairy products that are difficult for babies younger than 1 year old to break down. They are safe for use with the youngest infants and are not considered a dairy product.

Can any other inactive ingredients cause allergic reactions?

Hyland’s Baby Teething Gel is free of artificial flavors and dyes that may cause allergic reactions in children. However, if you know your child is allergic to an ingredient in the product, you should not use it.


Homeopathic Medicines

Are Hyland’s products regulated?

Yes, the manufacturing and marketing of Hyland’s homeopathic medicines are regulated as drugs by the FDA. The FDA has regulated homeopathic medicines since 1938, 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.

Are these herbal products?

No, these are not herbs, which use a larger quantity of plant material per dose. Homeopathic medicines use a minute dose of plant or mineral substance to address symptoms. And unlike herbal supplements which are regulated as foods, the FDA accepts homeopathic products as drugs. As drugs, homeopathic products must be manufactured in compliance with the FDA finished pharmaceutical Good Manufacturing Practices (GMPs) regulations for cleanliness, quality and testing; the FDA regularly inspects manufacturers for compliance. All Hyland’s manufacturing facilities are inspected by the FDA.


Buying Hyland’s

Where can I buy Hyland’s teething products?

These products are available at finer health food stores, groceries, pharmacies, chain drug stores and mass merchandisers nationwide. Click on the Store Locator button to find a store near you.

What other medicines does Hyland’s make for babies and children?

A: Hyland’s makes a complete line of all natural, safe, and effective medicines for children under 2 (Hyland’s Baby), and for kids 2-12 (Hyland’s 4 Kids). These medicines address common childhood ailments from colic and earaches, to coughs, colds, and allergies. To view our baby & kids product catalog, visit http://www.hylands.com/contact/BabyCat09Spreads.pdf

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For More Information

In the case of real medical emergency, you should always contact your doctor or health care professional immediately. Should there be questions, Hyland’s offers 24/7 emergency information about our products through on-call healthcare professional at 1-800-624-9659.

For more technical information regarding our products, we offer a Product Information Service that is staffed by a Pharmacist to answer questions regarding Hyland’s homeopathic medicines. Please note we don’t prescribe or offer medical advice, but we will be happy to field your questions regarding our products. The hours the service is staffed are as follows:

Monday & Wednesday: 9:00am – 11:00am – Pacific Time
Tuesday & Thursday: 1:00pm – 3:00pm – Pacific Time.

We can be reached at 800/624-9659.

If you would like to e-mail us, please direct your e-mail to shcinfo@hylands.com. Parents and caregivers can always visit our site at www.hylands.com or www.hylandsteething.com.


The Return of Hyland’s Baby Teething Tablets

Can you tell us why Hyland’s took Teething Tablets off the market?

Hyland’s voluntarily took Teething Tablets off the market in October 2010. We chose to exercise an abundance of caution by making this decision. Hyland’s and the FDA conducted a thorough review of all of our manufacturing processes and reports. Together, we identified manufacturing processes of Teething Tablets that could be improved to ensure uniformity in dosage. We also used this opportunity to refine the production, packaging and testing protocols on this product.

Why did it take so long for you to get them back on the market?

Following the FDA’s report, we performed a complete review of our manufacturing and other internal processes. This resulted in improvements across the board — validation of equipment, development of advanced testing protocols, packaging and formula updates, and enhancements to our adverse events reporting process. In the end, it was all worth it but indeed – it took a bit of time! Thank you for your patience. We know it has not been easy for many to endure teething without Hyland’s Baby Teething Tablets and we sincerely apologize for the inconvenience to your family.

What are the major differences between the original and the Hyland’s Baby Teething Tablets being distributed now?

We’ve added a child-resistant cap and updated the packaging and are introducing new strengths of the same ingredients that have calmed teething babies and their moms for more than 85 years. However, the most significant changes to the product are also the most invisible to you. We have made significant changes in our manufacturing process and introduced rigorous testing protocols. We can say with confidence that our Hyland’s Baby Teething Tablets go through the most rigorous testing protocols of any homeopathic baby product on the market today. Our manufacturing and testing processes are now even more precise, thus assuring you’ll get the same great results from Hyland’s Baby Teething Tablets – and that’s the best news of all.

How is this formula different from the original? Is it as effective?

We have kept all of the same ingredients that have made Hyland’s Baby Teething Tablets effective and safe for 85 years and improved effectiveness by increasing the homeopathic potency of each active ingredient. As homeopathic potency increases, raw drug concentration decreases, providing an even wider margin of safety than before.

Why is the new product more expensive than the original Hyland’s Baby Teething Tablets?

We have tried very much to shield our customers from the expense of these improvements (see above details). The price increase per bottle to you only partially offsets the increase in our manufacturing and analytical testing costs.

When and where can I find the new Hyland’s Baby Teething Tablets?

We expect Hyland’s Baby Teething Tablets will be available at all major pharmacies, groceries, natural foods stores, supercenters, and online retailers around mid-August to the beginning of September.


Safety Information

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

First and foremost, the quality of homeopathic medicines manufacturing is regulated by the Food and Drug Administration (FDA), as required in the Federal 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 12X 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 0.0000000000003% Belladonna alkaloids as stated on the label. As calculated, this means that each complete teething tablet contains only approximately 0.0000000000002 mg of Belladonna alkaloids.

The amount of Belladonna alkaloids in teething tablets is minuscule, especially when compared to conventional medicines that contain Belladonna alkaloids. To put the calculated amount of Belladonna in a Hyland’s Baby Teething Tablet into perspective, the 0.0000000000002 mg of Belladonna alkaloids is THOUSANDS OF TIMES below even the therapeutic amounts of Belladonna used in conventional anti-spasmodic medicines that doctors sometimes prescribe (0.2 to 5 milligrams of Belladonna alkaloids). The side effects (called anticholinergic 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 further clarify the homeopathic dosages of Belladonna in Baby Teething Tablets, a 10-pound child would have to accidentally ingest, all at the same time, more than a dozen bottles of 135 Baby Teething Tablets before experiencing even dry mouth from the product. Additionally, the body clears Belladonna alkaloids from any single dose in a matter of hours. Therefore, the Belladonna in the product would be very unlikely to build up in the system when taken as directed on the package label. Nonetheless, in the event of any accidental ingestion of a Hyland’s product, we encourage you to contact your own medical professional and/or poison control center immediately. Our on-call pharmacists are also available to assist you and your doctor with product-related information.

Hyland’s Baby 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 decisions regarding our products.

Please keep in mind that even if a child ate an entire bottle of homeopathic medicine, the minute total amount of active ingredients renders the chances of a medically serious anticholinergic toxicity effects highly unlikely. However, even with the very low doses of source materials that are in homeopathic medicines, extremely allergic individuals could experience acute allergic reactions to one or more ingredients.

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 toxicity 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 at once. 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


If you have purchased Hyland’s Calms Forté, Hyland’s Teething Tablets, Hyland’s Migraine Headache Relief, Hyland’s Colic Tablets, Hyland’s Leg Cramps with Quinine, Hyland’s Leg Cramps, Hyland’s Defend Cold & Cough Night, Hyland’s Defend Cold & Cough, Hyland’s Cough, or Hyland’s Seasonal Allergy Relief, on or after February 9, 2008, please visit the following link to obtain information that may affect your legal rights.