FDA.reportPublic FDA data

Cough and Congestion

Manufacturer
Biovea | Apotheca Company
Effective date
2022-03-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:06:43

Label at a glance#

ProductCough and Congestion
Active ingredientANTIMONY POTASSIUM TARTRATE, ARSENIC TRIOXIDE, ARSENIC TRIIODIDE, ARISAEMA TRIPHYLLUM ROOT, BAPTISIA TINCTORIA ROOT, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, POTASSIUM BROMIDE, SUS SCROFA LUNG, MERCURIC CHLORIDE, LOBARIA PULMONARIA, SULFUR IODIDE, URTICA URENS
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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:

OTC - PURPOSE SECTION

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:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

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:

INACTIVE INGREDIENT SECTION

Organic alcohol 20% v/v, purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by: BIOVEA

Dallas, TX 75202

1-800-961-4750

www.biovea.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 69607-0008-1

BIOVEA

HOMEOPATHICS

Cough & Congestion

Homeopathic

1 FL. OZ. (30ml)

COLD & COUGH†

Cough & CongestionCough & Congestion

Cough & CongestionCough & Congestion

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69607-0008-12022-03-09C16284748780-19d75b9d0-9f8e-f424-e053-dadaa90a57ceDRUG FACTS:
69607-0008-12020-01-31C16284748780-19d75b9d0-9f8e-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANTIMONY POTASSIUM TARTRATEACTIVE INGREDIENTDL6OZ476V31
ARISAEMA TRIPHYLLUM ROOTACTIVE INGREDIENTDM64K844DM1
ARSENIC TRIIODIDEACTIVE INGREDIENT3029988O2T1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WU1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
DROSERA ROTUNDIFOLIAACTIVE INGREDIENTQR44N9XPJQ1
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6E1
LOBARIA PULMONARIAACTIVE INGREDIENTD1YM0P5Z2T1
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1R1
POTASSIUM BROMIDEACTIVE INGREDIENTOSD78555ZM1
SULFUR IODIDEACTIVE INGREDIENTL6L8KA2AA01
SUS SCROFA LUNGACTIVE INGREDIENT7GL3G1COB31
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF91
ANTIMONY CATION (3+)ACTIVE MOIETY069647RPT51
ARISAEMA TRIPHYLLUM ROOTACTIVE MOIETYDM64K844DM1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WU1
BROMIDE IONACTIVE MOIETY952902IX061
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
DROSERA ROTUNDIFOLIAACTIVE MOIETYQR44N9XPJQ1
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6E1
LOBARIA PULMONARIAACTIVE MOIETYD1YM0P5Z2T1
MERCURIC CATIONACTIVE MOIETYED30FJ8Y421
SULFUR IODIDEACTIVE MOIETYL6L8KA2AA01
SUS SCROFA LUNGACTIVE MOIETY7GL3G1COB31
URTICA URENSACTIVE MOIETYIHN2NQ5OF91
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69607-000869607-0008-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ARSENIC TRIIODIDE3029988O2TACTIB
ARISAEMA TRIPHYLLUM ROOTDM64K844DMACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
DROSERA ROTUNDIFOLIAQR44N9XPJQACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
SUS SCROFA LUNG7GL3G1COB3ACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
SULFUR IODIDEL6L8KA2AA0ACTIB
URTICA URENSIHN2NQ5OF9ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b19ed0f4-2f3e-48c4-8029-3a6dc6908f17fc55093f-042b-4add-8e51-68d8d06c20482022-03-09WarningsExact identifier
spl id: b19ed0f4-2f3e-48c4-8029-3a6dc6908f17
spl set id: fc55093f-042b-4add-8e51-68d8d06c2048

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.