Active Ingredients
Eugenol 3X
Ulmus fulva 3X
Chamomilla 3X, 6X, 12X
Mentha piperita 4X
Clematis erecta 6X
Colocynthis 6X
Cuprum metallicum 6X
Myrrha 6X
Bryonia 12X, 30X
Calcarea carbonica 12X, 30X
Teething Drops Liquid
FDA Label NDC 63083-2120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Professional Complementary Health Formulas for the product Teething Drops (NDC 63083-2120). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, questions, indications, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Questions
Professional Formulas
PO Box 2034 Lake Oswego, OR 97035
Indications
For temporary relief of pain or irritability associated with teething.*
Otc - Purpose
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings
Consult a doctor if accompanied by fever and symptoms such as lethargy, lack of appetite, vomiting, or diarrhea. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a healthcare professional before use.
Directions
Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.
Other Information
Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.
Inactive Ingredients
10% ethanol, purified water, 8% vegetable glycerin (from soy).
Label
Est 1985
Professional Formulas
Complementary Health
Teething Drops
Homeopathic Remedy
2 FL. OZ. (59 mL)
Label Image (C120 Thumb)
* Please review the disclaimer below.
