c72

c72
SPL v1
SPL
SPL Set ID 24649b5b-ed21-4a32-8501-196b9e1348bb
Route
oral
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
black cohosh (1 [hp_X]) ginkgo (3 [hp_X]) cinchona officinalis bark (5 [hp_X]) goldenseal (6 [hp_X]) sus scrofa ear (12 [hp_X]) lycopodium clavatum spore (30 [hp_X]) bos taurus nerve sulfur digitalis carbonate ion
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 1984-08-15

Description

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


Medication Information

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.

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.

Description

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

Label

Est 1985

Professional Formulas

Complementary Health

Tinnitus Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Section 50565-1

Keep out of the reach of children.

Section 53414-9

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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.*

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


Structured Label Content

Warnings (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.

Directions (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 (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 (INACTIVE INGREDIENTS)

20% ethanol, purified water.

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Tinnitus Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1 (55105-1)

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications (INDICATIONS)

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

Active Ingredients (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)