TINNITUS REAL RELIEF- kali bromatum, cinchona officinalis, sulphur, dulcamara, hydrastis canadensis, arnica montana, bryonia causticum tablet, chewable 
HOMEOLAB USA 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 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 ears
buzzing in the ears
roaring in the ears, pressure
ear pain and headache
roaring in the ears
pain and buzzing in the ears
noise is insupportable
ringing, roaring, pulsating

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


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

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

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

TINNITUS  REAL RELIEF
kali bromatum, cinchona officinalis, sulphur, dulcamara, hydrastis canadensis, arnica montana, bryonia causticum tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6032
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM BROMIDE (UNII: OSD78555ZM) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION8 [hp_X]
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK8 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 [hp_X]
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP8 [hp_X]
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL8 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA8 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT8 [hp_X]
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM8 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-6032-090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/25/2012
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(60512-6032)

Revised: 10/2012
Document Id: 59e5548e-a0dd-4cbc-92bf-718665cc26db
Set id: 2efc8342-1fcf-43c2-9a3a-419e84959b41
Version: 1
Effective Time: 20121025
 
HOMEOLAB USA INC