Something sounds good – even to your fussy, teething baby. It’s the shake-shake of a Hyland’s Baby Teething Tablets bottle. These tablets have rocked the charts by being the #1 infant oral pain reliever in America!♩ They make nights bearable, days livable, and truly make the teething years way more groovy. Easy to use, no mess, no fuss – Hyland’s Baby Teething Tablets have perfect timing, right there whenever you need them.
♩AC Nielsen, Oral Pain – Baby at US xAOC, 52 weeks ending 4/12/2014
Uses: Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to cutting teeth. Helps reduce redness and teething discomfort.
“HPUS” indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Do no use: ▪ more often than directed
▪ for more than 7 days in a row unless directed by a doctor or dentist
▪ if your child has a known allergy to any ingredient in this product
Stop use and ask a doctor if: ▪ symptoms persist for more than 7 days or worsen
▪ swelling, rash, or fever develops ▪ irritation, pain, or redness persist or worsen
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
Other information ▪ do not use if imprinted tamper band is broken or missing
▪ Hyland’s may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659
Inactive ingredients Acacia Gum, Lactose N.F.
Questions or comments? (800) 624-9659
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
Directions ▪ children under 3 years of age: dissolve 2 to 3 tablets on tongue 4 times daily ▪ if you prefer, tablets may be dissolved in a teaspoon of water and then given to the child ▪ if the child is restless or wakeful, dissolve 2 tablets on tongue every hour for up to 6 doses ▪ Teething Tablets are very soft and dissolve almost instantly in the mouth ▪ please note: if your child has been crying or upset, your child may fall asleep after using this product because the pain has been relieved and your child can rest
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)
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.
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.
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.
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.
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.
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.
Hyland’s Baby Teething Tablets and Teething Gel have no added flavorings. Most people report that they taste faintly sweet.
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.
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.
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).
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.
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.
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.
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).
Hyland’s Baby Teething Tablets and Teething Gel contain the following active medicines for the relief of the symptoms of teething pain:
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.
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.
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.
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.
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.
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.
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.
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.
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