CARDIOTONE- adenosinum triphosphoricum dinatrum, cactus grandiflorus, convallaria majalis, heart (suis), magnesium gluconate, potassium gluconate, thyroidinum (suis), ubidecarenonum, germanium sesquioxide, strophanthus hispidus, adonis vernalis, digitalis purpurea 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:

Adenosinum Triphosphoricum Dinatrum 6X, Cactus Grandiflorus 6X, Convallaria Majalis 6X, Heart (Suis) 6X, Magnesium Gluconate 6X, Potassium Gluconate 6X, Thyroidinum (Suis) 6X, Ubidecarenonum 6X, Germanium Sesquioxide 8X, Strophanthus Hispidus 10X, Adonis Vernalis 12X, Digitalis Purpurea 12X.

INDICATIONS:

For temporary relief of difficulty breathing after walking, tiredness, feeling as if you can't breathe, and profuse perspiration.

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 a 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 difficulty breathing after walking, tiredness, feeling as if you can't breathe, and profuse perspiration.

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

CARDIOTONE

HOMEOPATHIC

1 FL OZ (30 ml)

Cardiotone

CARDIOTONE
adenosinum triphosphoricum dinatrum, cactus grandiflorus, convallaria majalis, heart (suis), magnesium gluconate, potassium gluconate, thyroidinum (suis), ubidecarenonum, germanium sesquioxide, strophanthus hispidus, adonis vernalis, digitalis purpurea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0512
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE)	ADENOSINE TRIPHOSPHATE DISODIUM	6 [hp_X] in 1 mL
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK)	SELENICEREUS GRANDIFLORUS STEM	6 [hp_X] in 1 mL
CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE)	CONVALLARIA MAJALIS	6 [hp_X] in 1 mL
PORK HEART (UNII: X876KJM95L) (PORK HEART - UNII:X876KJM95L)	PORK HEART	6 [hp_X] in 1 mL
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM GLUCONATE	6 [hp_X] in 1 mL
POTASSIUM GLUCONATE (UNII: 12H3K5QKN9) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM GLUCONATE	6 [hp_X] in 1 mL
SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ)	SUS SCROFA THYROID	6 [hp_X] in 1 mL
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46)	UBIDECARENONE	6 [hp_X] in 1 mL
GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T)	GERMANIUM SESQUIOXIDE	8 [hp_X] in 1 mL
STROPHANTHUS HISPIDUS SEED (UNII: MO892VI77K) (STROPHANTHUS HISPIDUS SEED - UNII:MO892VI77K)	STROPHANTHUS HISPIDUS SEED	10 [hp_X] in 1 mL
ADONIS VERNALIS (UNII: DX3ZNI25WK) (ADONIS VERNALIS - UNII:DX3ZNI25WK)	ADONIS VERNALIS	12 [hp_X] in 1 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	12 [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:43857-0512-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/02/2019

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0512) , api manufacture(43857-0512) , label(43857-0512) , pack(43857-0512)