TINNITUS RELIEF- kalium bromatum, nux vomica, china rubra, sulphur, sanguinaria canadensis, dulcamara, hydrastis canadensis, arn

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06), STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919), CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB), SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70), SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508), SOLANUM DULCAMARA STEM (UNII: IR986LE7DF) (SOLANUM DULCAMARA STEM - UNII:IR986LE7DF), GOLDENSEAL (UNII: ZW3Z
Available from:
HOMEOLAB USA INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Helps relieve ringing and buzzing in the ears This Homeopathic product of natural source provides symptomatic relief from ringing and buzzing in the ears.
Authorization status:
unapproved homeopathic
Authorization number:
60512-9054-1

TINNITUS RELIEF- kalium bromatum, nux vomica, china rubra, sulphur, sanguinaria

canadensis, dulcamara, hydrastis canadensis, arnica montana, bryonia alba, causticum pellet

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.

----------

DRUG FACTS

ACTIVE INGREDIENTS HPUS

Kalium bromatum 3X

Nux vomica 4X

China rubra 4X

Sulphur 4X

Sanguinaria canadensis 4X

Dulcamara 3X

Hydrastis canadensis 3X

Arnica montana 4X

Bryonia alba 4X

Causticum 6X

Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

PURPOSE

Helps relieve ringing and buzzing in the ears

USES

This Homeopathic product of natural source provides symptomatic relief from ringing and buzzing in

the ears.

WARNINGS

If symptoms persist or worsen, discontinue use and contact a health professional.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before

using this product.

Keep this and all medications out of reach of children.

DIRECTIONS

Adults: Allow 3 pellets to dissolve under the tongue 3 times a day or as directed by a health

professional.

For adult use only. Do not exceed recommended dosage.

OTHER INFORMATION

Do not use if cap seal is broken.

Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2 Canada

PRODUCT OF CANADA

CARTON

TINNITUS RELIEF

kalium bromatum, nux vomica, china rubra, sulphur, sanguinaria canadensis, dulcamara, hydrastis canadensis,

arnica montana, bryonia alba, causticum pellet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 512-9 0 54

Route of Administration

ORAL

HOMEOLAB USA INC.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO TASSIUM BRO MIDE (UNII: OSD78 555ZM) (BROMIDE ION - UNII:9 529 0 2IX0 6 )

POTASSIUM BROMIDE

3 [hp_X]

STRYCHNO S NUX-VO MICA SEED (UNII: 26 9 XH139 19 ) (STRYCHNOS NUX-VOMICA

SEED - UNII:26 9 XH139 19 )

STRYCHNOS NUX-VOMICA

SEED

4 [hp_X]

CINCHO NA O FFICINALIS BARK (UNII: S0 0 3A158 SB) (CINCHONA OFFICINALIS BARK -

UNII:S0 0 3A158 SB)

CINCHONA OFFICINALIS

BARK

4 [hp_X]

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

4 [hp_X]

SANGUINARIA CANADENSIS RO O T (UNII: N9 28 8 CD50 8 ) (SANGUINARIA CANADENSIS

ROOT - UNII:N9 28 8 CD50 8 )

SANGUINARIA

CANADENSIS ROOT

4 [hp_X]

SO LANUM DULCAMARA STEM (UNII: IR9 8 6 LE7DF) (SOLANUM DULCAMARA STEM -

UNII:IR9 8 6 LE7DF)

SOLANUM DULCAMARA

STEM

3 [hp_X]

GO LDENSEAL (UNII: ZW3Z11D0 JV) (GOLDENSEAL - UNII:ZW3Z11D0 JV)

GOLDENSEAL

3 [hp_X]

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

4 [hp_X]

BRYO NIA ALBA RO O T (UNII: T7J0 46 YI2B) (BRYONIA ALBA ROOT - UNII:T7J0 46 YI2B)

BRYONIA ALBA ROOT

4 [hp_X]

CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)

CAUSTICUM

6 [hp_X]

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRO SE (UNII: C151H8 M554)

LACTO SE (UNII: J2B2A4N9 8 G)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 512-9 0 54-1

8 0 in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

10 /18 /20 13

Labeler -

HOMEOLAB USA INC. (202032533)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

HOMEOLAB USA INC.

20 20 32533

ma nufa c ture (6 0 512-9 0 54)

Revised: 11/2013

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