FDA Label for Baby Teething
View Indications, Usage & Precautions
Baby 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.
Purpose
Chamomilla 6X...............................................................................................Irritability
Calcarea phosphorica 6X..................................................................................Teething, dentition
Coffea cruda 6X..............................................................................................Sleeplessness
Belladonna 12X (calculated as 0.0000000000003% alkaloids)...............................Redness and inflammation
Uses
Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to cutting teeth. Helps reduce redness and inflammation of gums.*
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
Warnings
Otc - Ask Doctor
As with any drug, ask a doctor before use if pregnant or nursing.
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 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.
Storage And Handling
Store at room temperature (68-77°F)
Inactive Ingredients
Lactose
* Please review the disclaimer below.