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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

ACTIVE INGREDIENTS:

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

PURPOSE:

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:

Professional Use Only

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.

INDICATIONS:

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.

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0006-1

TINNITUS

FORMULA

2 FL. OZ (60 ml)

TINNITUS  FORMULA

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH2 [hp_X]  in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO2 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]  in 1 mL
SUS SCROFA CEREBRUM (UNII: 4GB5DQR532) (SUS SCROFA CEREBRUM - UNII:4GB5DQR532) SUS SCROFA CEREBRUM6 [hp_X]  in 1 mL
SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV) SUS SCROFA EAR6 [hp_X]  in 1 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS12 [hp_X]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83027-0006-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/10/2023
Labeler - Nutritional Specialties, Inc. (032744609)

Revised: 4/2023
Document Id: 9c06873f-c7b6-41fd-b50e-4430141d124f
Set id: 4885c23c-093c-4ea0-8061-83cdeab9902e
Version: 1
Effective Time: 20230406
 
Nutritional Specialties, Inc.