TINNITUS FORMULA (cimicifuga racemosa, ginkgo biloba, cinchona officinalis, hydrastis canadensis, lycopodium clavatum, sulphur, cerebellum (suis), ear- suis digitalis purpurea, kali carbonicum spray

Tinnitus Formula by

Drug Labeling and Warnings

Tinnitus Formula by is a Homeopathic medication manufactured, distributed, or labeled by Nutritional Specialties, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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.

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

KEEP OUT OF REACH OF CHILDREN:

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

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.

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

1-800-245-1313

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC: 83027-0006-1

TINNITUS FORMULA

2 FL. OZ (60 ml)

INGREDIENTS AND APPEARANCE

TINNITUS FORMULA 
cimicifuga racemosa, ginkgo biloba, cinchona officinalis, hydrastis canadensis, lycopodium clavatum, sulphur, cerebellum (suis), ear (suis) digitalis purpurea, kali carbonicum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83027-0006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	2 [hp_X]  in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	2 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_X]  in 1 mL
SUS SCROFA CEREBRUM (UNII: 4GB5DQR532) (SUS SCROFA CEREBRUM - UNII:4GB5DQR532)	SUS SCROFA CEREBRUM	6 [hp_X]  in 1 mL
SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV)	SUS SCROFA EAR	6 [hp_X]  in 1 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	12 [hp_X]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83027-0006-1	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/10/2023

Labeler - Nutritional Specialties, Inc. (032744609)