The following Structured Product Label (SPL) was submitted to the FDA by Professional Complementary Health Formulas for the product Otitis Media Drops (NDC 63083-2153). 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.
Calcarea carbonica 3X
Pulsatilla 4X, 12X, 30X
Aconitum napellus 6X
Ear 6X, 60X, 100X, 200X
Belladonna 12X
Tellurium metallicum 12X
Ferrum phosphoricum 12X, 30X
Gelsemium sempervirens 30X
Mercurius vivus 30X
Streptococcus pneumoniae 30X
Haemophilus influenzae 60X
Professional Formulas
PO Box 2034 Lake Oswego, OR 97035
For the temporary relief of minor earache or ringing in the ears.*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, persistent headache, or loss of hearing, consult a doctor. 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.
Keep out of the reach of children.
If pregnant or breastfeeding, ask a healthcare professional before use.
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. Consult a physician for use in children under 12 years of age.
Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.
10% ethanol, purified water, 8% vegetable glycerin (from soy).
Est 1985
Professional Formulas
Complementary Health
Otitis Media Drops
Homeopathic Remedy
2 FL. OZ. (59 mL)
Label Image (C153 Thumb)
* Please review the disclaimer below.
