Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 4885c23c-093c-4ea0-8061-83cdeab9902e
Route
ORAL
Published
Effective Date 2025-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Black Cohosh (2 [hp_X]) Ginkgo (3 [hp_X]) Cinchona Officinalis Bark (6 [hp_X]) Goldenseal (12 [hp_X]) Lycopodium Clavatum Spore (30 [hp_X]) Sulfur Sus Scrofa Cerebrum Sus Scrofa Ear Digitalis Carbonate Ion
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-04-10
Description

Cerebellum 6X, 12X, 30X, Cimicifuga Racemosa 2X, Cinchona Officinalis 3X, 6X, 12X, 30X, Digitalis Purpurea 12X, Ear 6X, 12X, 30X, Ginkgo Biloba 2X, Hydrastis Canadensis 6X, Kali Carbonicum 30X, Lycopodium Clavatum 6X, 12X, Sulphur 6X, 12X.

Purpose

Cerebellum- Support of Brain,† Cimicifuga Racemosa – Relieves Symptoms Associated with Tinnitus such as Violent Noises in the Ear,† Cinchona Officinalis - Relieves Symptoms Associated with Tinnitus such as ringing in the Ears, Noises, and Dizziness,† Digitalis Purpurea - Relieves Symptoms Associated with Tinnitus such as Noises in Head,† Ear – Support of Ear,† Ginkgo Biloba - Relieves Symptoms Associated with Tinnitus such as Buzzing Noises in Ears,† Hydrastis Canadensis – Relieves Symptoms Associated with Tinnitus,† Kali Carbonicum - Relieves Symptoms Associated with Tinnitus such as Noises in Ear with Headache, and Ringing in Ears,† Lycopodium Clavatum – Relieves Symptoms Associated with Tinnitus,† Sulphur – Relieves Symptoms Associated with Tinnitus such as Dizziness† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Medication Information

Purpose

Cerebellum- Support of Brain,† Cimicifuga Racemosa – Relieves Symptoms Associated with Tinnitus such as Violent Noises in the Ear,† Cinchona Officinalis - Relieves Symptoms Associated with Tinnitus such as ringing in the Ears, Noises, and Dizziness,† Digitalis Purpurea - Relieves Symptoms Associated with Tinnitus such as Noises in Head,† Ear – Support of Ear,† Ginkgo Biloba - Relieves Symptoms Associated with Tinnitus such as Buzzing Noises in Ears,† Hydrastis Canadensis – Relieves Symptoms Associated with Tinnitus,† Kali Carbonicum - Relieves Symptoms Associated with Tinnitus such as Noises in Ear with Headache, and Ringing in Ears,† Lycopodium Clavatum – Relieves Symptoms Associated with Tinnitus,† Sulphur – Relieves Symptoms Associated with Tinnitus such as Dizziness† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Cerebellum 6X, 12X, 30X, Cimicifuga Racemosa 2X, Cinchona Officinalis 3X, 6X, 12X, 30X, Digitalis Purpurea 12X, Ear 6X, 12X, 30X, Ginkgo Biloba 2X, Hydrastis Canadensis 6X, Kali Carbonicum 30X, Lycopodium Clavatum 6X, 12X, Sulphur 6X, 12X.

Uses:

Provides homeopathic assistance in relieving symptoms associated with tinnitus such as ringing in the ears, noises, and dizziness.†

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

Purpose:

Cerebellum- Support of Brain,† Cimicifuga Racemosa – Relieves Symptoms Associated with Tinnitus such as Violent Noises in the Ear,† Cinchona Officinalis - Relieves Symptoms Associated with Tinnitus such as ringing in the Ears, Noises, and Dizziness,† Digitalis Purpurea - Relieves Symptoms Associated with Tinnitus such as Noises in Head,† Ear – Support of Ear,† Ginkgo Biloba - Relieves Symptoms Associated with Tinnitus such as Buzzing Noises in Ears,† Hydrastis Canadensis – Relieves Symptoms Associated with Tinnitus,† Kali Carbonicum - Relieves Symptoms Associated with Tinnitus such as Noises in Ear with Headache, and Ringing in Ears,† Lycopodium Clavatum – Relieves Symptoms Associated with Tinnitus,† Sulphur – Relieves Symptoms Associated with Tinnitus such as Dizziness†

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

Warnings:

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

1-800-245-1313

Directions:

• Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage.

• Do not take within 15 minutes of consuming food, beverage or brushing teeth.

Consult a physician for use in children under 12 years of age.

Active Ingredients:

Cerebellum 6X, 12X, 30X, Cimicifuga Racemosa 2X, Cinchona Officinalis 3X, 6X, 12X, 30X, Digitalis Purpurea 12X, Ear 6X, 12X, 30X, Ginkgo Biloba 2X, Hydrastis Canadensis 6X, Kali Carbonicum 30X, Lycopodium Clavatum 6X, 12X, Sulphur 6X, 12X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0006-1

TINNITUS  FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses: (USES:)

Provides homeopathic assistance in relieving symptoms associated with tinnitus such as ringing in the ears, noises, and dizziness.†

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

Purpose: (PURPOSE:)

Cerebellum- Support of Brain,† Cimicifuga Racemosa – Relieves Symptoms Associated with Tinnitus such as Violent Noises in the Ear,† Cinchona Officinalis - Relieves Symptoms Associated with Tinnitus such as ringing in the Ears, Noises, and Dizziness,† Digitalis Purpurea - Relieves Symptoms Associated with Tinnitus such as Noises in Head,† Ear – Support of Ear,† Ginkgo Biloba - Relieves Symptoms Associated with Tinnitus such as Buzzing Noises in Ears,† Hydrastis Canadensis – Relieves Symptoms Associated with Tinnitus,† Kali Carbonicum - Relieves Symptoms Associated with Tinnitus such as Noises in Ear with Headache, and Ringing in Ears,† Lycopodium Clavatum – Relieves Symptoms Associated with Tinnitus,† Sulphur – Relieves Symptoms Associated with Tinnitus such as Dizziness†

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

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

1-800-245-1313

Directions: (DIRECTIONS:)

• Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage.

• Do not take within 15 minutes of consuming food, beverage or brushing teeth.

Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Cerebellum 6X, 12X, 30X, Cimicifuga Racemosa 2X, Cinchona Officinalis 3X, 6X, 12X, 30X, Digitalis Purpurea 12X, Ear 6X, 12X, 30X, Ginkgo Biloba 2X, Hydrastis Canadensis 6X, Kali Carbonicum 30X, Lycopodium Clavatum 6X, 12X, Sulphur 6X, 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0006-1

TINNITUS  FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:03.605813 · Updated: 2026-03-14T23:17:39.188617