VITALIZER- echinacea (angustifolia), iodium, arsenicum album, aurum metallicum, calcarea fluorica, gallicum acidum, hekla lava, niccolum sulphuricum, phosphorus, sedum acre, sempervivum tectorum, senecio aureus, blatta americana, onosmodium virginianum 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:

Echinacea 3X, Iodium 6X, Arsenicum Album 12X, Aurum Metallicum 12X, Calcarea Fluorica 12X, Gallicum Acidum 12X, Hekla Lava 12X, Niccolum Sulphuricum 12X, Phosphorus 12X, Sedum Acre 12X, Sempervivum Tectorum 12X, Senecio Aureus 12X, Blatta Americana 16X, Onosmodium Virginianum 30C.

PURPOSE:

For temporary relief of fatigue, weakness after exhausting diseases, headaches and sensitivity to light and noise.

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:

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 fatigue, weakness after exhausting diseases, headaches and sensitivity to light and noise.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

VITALIZER

HOMEOPATHIC

1 FL OZ (30 ml)

VITALIZER

VITALIZER
echinacea (angustifolia), iodium, arsenicum album, aurum metallicum, calcarea fluorica, gallicum acidum, hekla lava, niccolum sulphuricum, phosphorus, sedum acre, sempervivum tectorum, senecio aureus, blatta americana, onosmodium virginianum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0629
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA WHOLE	3 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	6 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO)	GOLD	12 [hp_X] in 1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	12 [hp_X] in 1 mL
GALLIC ACID MONOHYDRATE (UNII: 48339473OT) (GALLIC ACID - UNII:632XD903SP)	GALLIC ACID MONOHYDRATE	12 [hp_X] in 1 mL
HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK)	HEKLA LAVA	12 [hp_X] in 1 mL
NICKEL SULFATE HEXAHYDRATE (UNII: JC9WZ4FK68) (NICKEL CATION - UNII:OIS2CXW7AM)	NICKEL SULFATE HEXAHYDRATE	12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL
SEDUM ACRE WHOLE (UNII: 2496VW6S9J) (SEDUM ACRE - UNII:2496VW6S9J)	SEDUM ACRE WHOLE	12 [hp_X] in 1 mL
SEMPERVIVUM TECTORUM LEAF (UNII: 3DGJ7BUA01) (SEMPERVIVUM TECTORUM LEAF - UNII:3DGJ7BUA01)	SEMPERVIVUM TECTORUM LEAF	12 [hp_X] in 1 mL
PACKERA AUREA WHOLE (UNII: 5WS1632J8W) (PACKERA AUREA - UNII:5WS1632J8W)	PACKERA AUREA WHOLE	12 [hp_X] in 1 mL
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089)	PERIPLANETA AMERICANA	16 [hp_X] in 1 mL
ONOSMODIUM VIRGINIANUM (UNII: 604NK4250S) (ONOSMODIUM VIRGINIANUM - UNII:604NK4250S)	ONOSMODIUM VIRGINIANUM	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:43857-0629-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/06/2023

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0629) , api manufacture(43857-0629) , label(43857-0629) , pack(43857-0629)