SINUS PAIN (antimonium tartaricum, arsenicum iodatum, asafoetida, baptisia tinctoria, echinacea- angustifolia, eupatorium perfoliatum, euphorbia pilulifera, hepar sulphuris calcareum, kali bichromicum, kreosotum, lachesis mutus, mercurius iodatus ruber, pyrogenium, silicea, teucrium marum spray

Sinus Pain by

Drug Labeling and Warnings

Sinus Pain by is a Homeopathic medication manufactured, distributed, or labeled by Biovea, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Antimonium Tartaricum 4X, Arsenicum Iodatum 200C, Asafoetida 30C, Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Eupatorium Perfoliatum 6X, Euphorbia Pilulifera 3X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30C, Kreosotum 30C, Lachesis Mutus 200C, Mercurius Iodatus Ruber 10X, 200C, Pyrogenium 200C, Silicea 30C, Teucrium Marum 3X.

INDICATIONS:

Fast-acting homeopathic oral spray for the temporary relief of symptoms associated with sinus congestion and sinus headache.†

†These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

If symptoms persist, consult a doctor.

If pregnant or breast feeding, ask a doctor before use.

Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

Adults & children over 12. Spray twice under the tongue 3 times per day. For severe symptoms, dosage may be taken up to six times the first day.

Children 12 & under. Consult a doctor prior to use.

INDICATIONS:

Fast-acting homeopathic oral spray for the temporary relief of symptoms associated with sinus congestion and sinus headache.†

†These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, purified water.

QUESTIONS:

Distributed by: BIOVEA

7702 E. Doubletree Ranch Rd.

Suite 300, #307  Scottsdale, AZ  85258

1-800-961-4750  www.biovea.com

PACKAGE LABEL DISPLAY:

NDC# 69607-0013-1

BIOVEA

HOMEOPATHICS

Sinus Pain

Homeopathic

1 FL. OZ. (30ml)

NATURAL RELIEF†

INGREDIENTS AND APPEARANCE

SINUS PAIN 
antimonium tartaricum, arsenicum iodatum, asafoetida, baptisia tinctoria, echinacea (angustifolia), eupatorium perfoliatum, euphorbia pilulifera, hepar sulphuris calcareum, kali bichromicum, kreosotum, lachesis mutus, mercurius iodatus ruber, pyrogenium, silicea, teucrium marum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69607-0013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	6 [hp_X]  in 1 mL
ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIIODIDE	200 [hp_C]  in 1 mL
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1)	ASAFETIDA	30 [hp_C]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X]  in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]  in 1 mL
EUPHORBIA HIRTA FLOWERING TOP (UNII: 6H89ZY31MR) (EUPHORBIA HIRTA FLOWERING TOP - UNII:6H89ZY31MR)	EUPHORBIA HIRTA FLOWERING TOP	3 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	30 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	30 [hp_C]  in 1 mL
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	30 [hp_C]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	200 [hp_C]  in 1 mL
MERCURIC IODIDE (UNII: R03O05RB0P) (MERCURIC IODIDE - UNII:R03O05RB0P)	MERCURIC IODIDE	200 [hp_C]  in 1 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	200 [hp_C]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_C]  in 1 mL
TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA)	TEUCRIUM MARUM	3 [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: 69607-0013-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/07/2018

Labeler - Biovea (089173699)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(69607-0013) , api manufacture(69607-0013) , label(69607-0013) , pack(69607-0013)