COUGH AND CONGESTION (antimonium tartaricum, arsenicum album, arsenicum iodatum, arum triphyllum, baptisia tinctoria, bryonia (alba), drosera- rotundifolia, echinacea angustifolia, eupatorium perfoliatum, kali bromatum, lung suis, mercurius corrosivus, sticta pulmonaria, sulphur iodatum, urtica urens spray

Cough and Congestion by

Drug Labeling and Warnings

Cough and Congestion 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 200C, Arsenicum Album 200C, Arsenicum Iodatum 200C, Arum Triphyllum 30C, Baptisia Tinctoria 3X, Bryonia (Alba) 200C, Drosera (Rotundifolia) 30X, Echinacea Angustifolia 3X, Eupatorium Perfoliatum 200C, Kali Bromatum 6X, Lung Suis 6X, Mercurius Corrosivus 200C, Sticta Pulmonaria 200C, Sulphur Iodatum 200C, Urtica Urens 200C.

INDICATIONS:

Fast-acting homeopathic oral spray for the temporary relief of cough, mucous buildup, chest tightness & soreness associated with cough & bronchial indications.†

†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 cough, mucous buildup, chest tightness & soreness associated with cough & bronchial indications.†

†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

Dallas, TX 75202

1-800-961-4750

www.biovea.com

PACKAGE LABEL DISPLAY:

NDC# 69607-0008-1

BIOVEA

HOMEOPATHICS

Cough & Congestion

Homeopathic

1 FL. OZ. (30ml)

COLD & COUGH†

INGREDIENTS AND APPEARANCE

COUGH AND CONGESTION 
antimonium tartaricum, arsenicum album, arsenicum iodatum, arum triphyllum, baptisia tinctoria, bryonia (alba), drosera (rotundifolia), echinacea angustifolia, eupatorium perfoliatum, kali bromatum, lung suis, mercurius corrosivus, sticta pulmonaria, sulphur iodatum, urtica urens spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69607-0008
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	200 [hp_C]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	200 [hp_C]  in 1 mL
ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIIODIDE	200 [hp_C]  in 1 mL
ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM)	ARISAEMA TRIPHYLLUM ROOT	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
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	200 [hp_C]  in 1 mL
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ)	DROSERA ROTUNDIFOLIA	30 [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	200 [hp_C]  in 1 mL
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)	POTASSIUM BROMIDE	6 [hp_X]  in 1 mL
SUS SCROFA LUNG (UNII: 7GL3G1COB3) (SUS SCROFA LUNG - UNII:7GL3G1COB3)	SUS SCROFA LUNG	6 [hp_X]  in 1 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CHLORIDE	200 [hp_C]  in 1 mL
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T)	LOBARIA PULMONARIA	200 [hp_C]  in 1 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0)	SULFUR IODIDE	200 [hp_C]  in 1 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	200 [hp_C]  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: 69607-0008-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/02/2015

Labeler - Biovea (089173699)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(69607-0008) , api manufacture(69607-0008) , label(69607-0008) , pack(69607-0008)