FDA Label for Infants Teething
View Indications, Usage & Precautions
Infants Teething Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients Hpus
Chamomilla 6X
Calcarea phosphorica 6X
Coffea cruda 6X
Belladonna 12X (calculated as 0.0000000000003% alkaloids)
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
Purpose
Irritability
Teething, dentition
Sleeplessness
Redness and pain
Uses
Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to cutting teeth. Helps reduce gum redness and pain.
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
Otc - Ask Doctor
As with any drug, ask a doctor before use if pregnant or nursing.
Stop use and ask a doctor if:
- symptoms do not improve in 7 days
- swelling, rash of fever develops
- irritation, pain and redness worsens.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children.
In case of emergency or accidental overdose, contact a medical professional or a poison control center immediately.
Otc - Do Not Use
Do not 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.
Do not use if security seal is broken or missing.
Directions
Allow 2 or 3 tablets to dissolve under the tongue 4 times a day, or as directed by a licensed health care professional. If the child is restless or wakeful, allow 2 tablets to dissolve under the tongue every hour for 6 doses, or as directed by a licensed health care professional. If preferred, tablets may be dissolved in a teaspoon of water and then given to the child. CVS/pharmacy Teething Tablets are very soft and will dissolve almost instantly in the mouth. Please note: if your child has been crying or is upset, your child may fall asleep after using this product because the pain has been relieved and your child can rest.
Other Information
Store at room temperature (68°-77°F)
Inactive Ingredients
Dextrose, maltodextrin, corn starch, crospovidone, magnesium stearate, lactose.
* Please review the disclaimer below.