FDA Label for Otitis Media Drops 2153
View Indications, Usage & Precautions
Otitis Media Drops 2153 Product Label
The following document was submitted to the FDA by the labeler of this product Professional Complementary Health Formulas. 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
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
Questions
Professional Formulas
PO Box 2034 Lake Oswego, OR 97035
Indications
For the temporary relief of minor earache or ringing in the ears.*
Otc - Purpose
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings
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.
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. 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
Otitis Media Drops
Homeopathic Remedy
2 FL. OZ. (59 mL)
* Please review the disclaimer below.