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  5. Label Information: Tinnitus Real Relief

FDA Label for Tinnitus Real Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS HPUS
    2. PURPOSE
    3. REFERENCES
    4. USES
    5. WARNINGS
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. CARTON

Tinnitus Real Relief Product Label

The following document was submitted to the FDA by the labeler of this product Homeolab Usa Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients Hpus



Kali bromatum (Potassium bromide) 8X
Cinchona officinalis (Peruvian bark) 8X
Sulphur (Sublimed sulfur) 8X
Dulcamara (Bittersweet) 8X
Hydrastis canadensis (Golden seal) 8X
Arnica montana (Leopard's bane) 8X
Bryonia (White bryony) 8X
Causticum (Hahnmann's causticum) 8X


Purpose



Ringing in the earsbuzzing in the earsroaring in the ears, pressureear pain and headacheroaring in the earspain and buzzing in the earsnoise is insupportableringing, roaring, pulsating

References



The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Uses



This homeopathic medicine helps relieve symptoms associated with tinnitus:

- ringing and buzzing in the ear

- ear pain and pressure

- headache

Warnings





Otc - Stop Use



Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 3 times daily and reduce intake with improvement or as directed by a health professional.


Age Dose
Adults and children 12 years of age and older2 tablets
Children 2 to 11 years of age
1 tablet


Other Information



Store at room temperature (68 - 77F).

Do not use if seal is broken or missing.


Inactive Ingredients



Lactose, magnesium stearate.



Carton



image of carton label - bx realtabs tinnitus

image of carton label - bx realtabs tinnitus


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