CARDIOFORCE I- arnica montana, cactus grandiflorus, capsicum annuum, digitalis purpurea, kali phosphoricum, laurocerasus, spigelia anthelmia, tabacum, aconitum napellus, agaricus muscarius, aurum muriaticum, glonoinum, ignatia amara, kalmia latifolia, latrodectus mactans, valeriana officinalis 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:

Arnica Montana 3X, Cactus Grandiflorus 3X, Capsicum Annuum 3X, Digitalis Purpurea 6X, Kali Phosphoricum 6X, Laurocerasus 6X, Spigelia Anthelmia 3X, Tabacum 6X, Aconitum Napellus 12X, Aurum Muriaticum 12X, Glonoinum 12X, Ignatia Amara 12X, Kalmia Latifolia 12X, Latrodectus Mactans 12X, Valeriana Officinalis 12X.

INDICATIONS:

For temporary relief of heaviness of the chest, tiredness after minimal exercise, difficulty breathing with heaviness.

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 heaviness of the chest, tiredness after minimal exercise, difficulty breathing with heaviness.

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

CARDIOFORCE I

HOMEOPATHIC

1 FL OZ (30 ml)

Cardioforce I

CARDIOFORCE I
arnica montana, cactus grandiflorus, capsicum annuum, digitalis purpurea, kali phosphoricum, laurocerasus, spigelia anthelmia, tabacum, aconitum napellus, agaricus muscarius, aurum muriaticum, glonoinum, ignatia amara, kalmia latifolia, latrodectus mactans, valeriana officinalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0442
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X] in 1 mL
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK)	SELENICEREUS GRANDIFLORUS STEM	3 [hp_X] in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	3 [hp_X] in 1 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	6 [hp_X] in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	6 [hp_X] in 1 mL
PRUNUS LAUROCERASUS LEAF (UNII: F26P2D4757) (PRUNUS LAUROCERASUS LEAF - UNII:F26P2D4757)	PRUNUS LAUROCERASUS LEAF	6 [hp_X] in 1 mL
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	6 [hp_X] in 1 mL
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU)	TOBACCO LEAF	6 [hp_X] in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	12 [hp_X] in 1 mL
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037)	AMANITA MUSCARIA FRUITING BODY	12 [hp_X] in 1 mL
GOLD TRICHLORIDE (UNII: 15443PR153) (GOLD CATION (3+) - UNII:7XM25QYI14)	GOLD TRICHLORIDE	12 [hp_X] in 1 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	12 [hp_X] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X] in 1 mL
KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18)	KALMIA LATIFOLIA LEAF	12 [hp_X] in 1 mL
LATRODECTUS MACTANS (UNII: XJJ7QA858R) (LATRODECTUS MACTANS - UNII:XJJ7QA858R)	LATRODECTUS MACTANS	12 [hp_X] in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	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:43857-0442-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/08/2017

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0442) , api manufacture(43857-0442) , label(43857-0442) , pack(43857-0442)