VAXOSODE- echinacea (angustifolia), baptisia tinctoria, chelidonium majus, hydrastis canadensis, phytolacca decandra, tabebuia impetiginosa, taraxacum officinale, uncaria tomentosa, thuja occidentalis, calcarea carbonica, silicea, belladonna, chamomilla, lycopodium clavatum, rhus tox, arsenicum album, pertussinum liquid
Synergy Formulas, 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:

Echinacea (Angustifolia) MT, Baptisia Tinctoria MT, 3X, Chelidonium Majus 3X, Hydrastis Canadensis 3X, Phytolacca Decandra 3X, Tabebuia Impetiginosa 3X, Taraxacum Officinale 3X, Uncaria Tomentosa 3X, Thuja Occidentalis 6X, 30X, 200X, Calcarea Carbonica 8X, Silicea 8X, 30X, Belladonna 12X, Chamomilla 12X, Lycopodium Clavatum 12X, Rhus Tox 12X, Arsenicum Album 12X, 30X, Pertussinum 30X, 60X, 200X, 1000X

INDICATIONS:

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

WARNINGS:

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

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

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 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:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322

PACKAGE LABEL DISPLAY:

Synergy Formulas

VAXOSODE

HOMEOPATHIC

2 FL OZ (60 ml)

VAXOSODE

VAXOSODE
echinacea (angustifolia), baptisia tinctoria, chelidonium majus, hydrastis canadensis, phytolacca decandra, tabebuia impetiginosa, taraxacum officinale, uncaria tomentosa, thuja occidentalis, calcarea carbonica, silicea, belladonna, chamomilla, lycopodium clavatum, rhus tox, arsenicum album, pertussinum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43772-0052
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	1 [hp_X] in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	1 [hp_X] in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	3 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	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
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	3 [hp_X] in 1 mL
CAT'S CLAW (UNII: 9060PRM18Q) (CAT'S CLAW - UNII:9060PRM18Q)	CAT'S CLAW	3 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	6 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	8 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	8 [hp_X] in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X] in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	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
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED (UNII: U364V64HUN) (HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - UNII:U364V64HUN)	HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED	30 [hp_X] 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:43772-0052-1	60 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/19/2015

Labeler - Synergy Formulas, Inc. (069579220)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43772-0052) , api manufacture(43772-0052) , label(43772-0052) , pack(43772-0052)