Tinnitus Drops Liquid
FDA Label NDC 63083-2072

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 Tinnitus Drops (NDC 63083-2072). 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.

Active Ingredients

Cimicifuga racemosa 1X
Ginkgo biloba 1X
Cinchona officinalis 3X, 6X, 12X, 30X
Hydrastis canadensis 5X
Ear 6X, 12X, 30X
Lycopodium clavatum 6X, 12X
Major nerves 6X, 12X, 30X
Sulphur 6X, 12X
Digitalis purpurea 12X
Kali carbonicum 30X

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

For the temporary relief of noise in the ears, such as ringing, roaring, buzzing, hissing, or whistling.*

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, dizziness, 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 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

20% ethanol, purified water.

Label

Est 1985

Professional Formulas

Complementary Health

Tinnitus Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label Image (C72 Thumb)

Label Image (C72 Thumb)

* Please review the disclaimer below.