VAX- baptisia tinctoria, echinacea (angustifolia), hydrastis canadensis, tabebuia impetiginosa, trifolium pratense, arnica montana, calendula officinalis, chelidonium majus, leptandra virginica, ligusticum porteri, lomatium dissectum, myrrha, nasturtium aquaticum, phytolacca decandra, taraxacum officinale, trigonella foenum-graecum, urtica dioica, astragalus membranaceus, propolis, glandula suprarenalis suis, thymus (suis), arsenicum album, belladonna, chamomilla, lycopodium clavatum, rhus tox, silicea, liquid
BioActive Nutritional, 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:

Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Hydrastis Canadensis 3X, Tabebuia Impetiginosa 3X, Trifolium Pratense 3X, Arnica Montana 4X, Calendula Officinalis 4X, Chelidonium Majus 4X, Leptandra Virginica 4X, Ligusticum Porteri 4X, Lomatium Dissectum 4X, Myrrha 4X, Nasturtium Aquaticum 4X, Phytolacca Decandra 4X, Taraxacum Officinale 4X, Trigonella Foenum-Graecum 4X, Urtica Dioica 4X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Suis 8X, Thymus (Suis) 8X, Arsenicum Album 12X, Belladonna 12X, Chamomilla 12X, Lycopodium Clavatum 12X, Rhus Tox 12X, Silicea 30X, Thuja Occidentalis 30X, Antimonium Crudum 30X, 200X, Pertussinum 30C, Tetanus Toxin 30X, Thimerosal 30C.

INDICATIONS:

For temporary relief of skin irritation, dry cough, eczema, and fever.

WARNINGS:

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

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

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

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of skin irritation, dry cough, eczema, and fever.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PAKCAGE LABEL DISPLAY:

BioActive Homeopathic
VAX
1 FL OZ (30 ml)

VAX

VAX
baptisia tinctoria, echinacea (angustifolia), hydrastis canadensis, tabebuia impetiginosa, trifolium pratense, arnica montana, calendula officinalis, chelidonium majus, leptandra virginica, ligusticum porteri, lomatium dissectum, myrrha, nasturtium aquaticum, phytolacca decandra, taraxacum officinale, trigonella foenum-graecum, urtica dioica, astragalus membranaceus, propolis, glandula suprarenalis suis, thymus (suis), arsenicum album, belladonna, chamomilla, lycopodium clavatum, rhus tox, silicea, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0386
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y)	BAPTISIA TINCTORIA	3 [hp_X] in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X] in 1 mL
TABEBUIA IMPETIGINOSA BARK (UNII: 6GLA1946WX) (TABEBUIA IMPETIGINOSA BARK - UNII:6GLA1946WX)	TABEBUIA IMPETIGINOSA BARK	3 [hp_X] in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828)	TRIFOLIUM PRATENSE FLOWER	3 [hp_X] in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	4 [hp_X] in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	4 [hp_X] in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	4 [hp_X] in 1 mL
VERONICASTRUM VIRGINICUM ROOT (UNII: M2O62YTN42) (CULVER'S ROOT - UNII:M2O62YTN42)	VERONICASTRUM VIRGINICUM ROOT	4 [hp_X] in 1 mL
LIGUSTICUM PORTERI ROOT (UNII: 81FGO4H42J) (LIGUSTICUM PORTERI ROOT - UNII:81FGO4H42J)	LIGUSTICUM PORTERI ROOT	4 [hp_X] in 1 mL
LOMATIUM DISSECTUM ROOT (UNII: 5329928G5N) (LOMATIUM DISSECTUM ROOT - UNII:5329928G5N)	LOMATIUM DISSECTUM ROOT	4 [hp_X] in 1 mL
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)	MYRRH	4 [hp_X] in 1 mL
NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM OFFICINALE - UNII:YH89GMV676)	NASTURTIUM OFFICINALE	4 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	4 [hp_X] in 1 mL
FENUGREEK SEED (UNII: 654825W09Z) (FENUGREEK SEED - UNII:654825W09Z)	FENUGREEK SEED	4 [hp_X] in 1 mL
URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46)	URTICA DIOICA	4 [hp_X] in 1 mL
ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF) (ASTRAGALUS PROPINQUUS ROOT - UNII:922OP8YUPF)	ASTRAGALUS PROPINQUUS ROOT	6 [hp_X] in 1 mL
PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF)	PROPOLIS WAX	6 [hp_X] in 1 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	8 [hp_X] in 1 mL
SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62)	SUS SCROFA THYMUS	8 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X] in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	12 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	30 [hp_X] in 1 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	30 [hp_X] in 1 mL
BORDETELLA PERTUSSIS (UNII: 2QNL82089R) (BORDETELLA PERTUSSIS - UNII:2QNL82089R)	BORDETELLA PERTUSSIS	30 [hp_C] in 1 mL
TETANUS TOXIN (UNII: RS7296A9LB) (TETANUS TOXIN - UNII:RS7296A9LB)	TETANUS TOXIN	30 [hp_C] in 1 mL
THIMEROSAL (UNII: 2225PI3MOV) (ETHYLMERCURITHIOSALICYLIC ACID - UNII:4071N4J64W)	THIMEROSAL	30 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0386-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/21/2016	09/10/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/21/2016	09/10/2023

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0386) , api manufacture(43857-0386) , label(43857-0386) , pack(43857-0386)

Revised: 8/2023

Document Id: 1971c48d-2d77-47e7-a63f-50340d0b5d61

Set id: 9efc6013-5535-4010-be95-b4aa025b3609

Version: 3

Effective Time: 20230825

BioActive Nutritional, Inc.