DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

CARDIOFORCE II- abrotanum, boldo, cimicifuga racemosa, convallaria majalis, kali phosphoricum, taraxacum officinale, magnesia sulphurica, oleander, natrum muriaticum, bellis perennis 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:

Abrotanum 3X, Boldo 3X, Cimicifuga Racemosa 3X,Convallaria Majalis 3X, Kali Phosphoricum 3X, Taraxacum Officinale 3X, Magnesia Sulphurica 5X, Oleander 8X, Natrum Muriaticum 12X, Bellis Perennis 30C

INDICATIONS:

For temporary relief of mild dizziness, feeling faint, aching of legs, weakness of the lower limbs, swelling of legs.   

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 mild dizziness, feeling faint, aching of legs, weakness of the lower limbs, swelling of legs.   

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

PACKAGE LABEL DISPLAY:

BioActive Homeopathic

CARDIOFORCE II

1 FL OZ (30 ml)

CARDIOFORCE  II
abrotanum, boldo, cimicifuga racemosa, convallaria majalis, kali phosphoricum, taraxacum officinale, magnesia sulphurica, oleander, natrum muriaticum, bellis perennis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0321
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0)	ARTEMISIA ABROTANUM FLOWERING TOP	3 [hp_X]  in 1 mL
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O)	PEUMUS BOLDUS LEAF	3 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	3 [hp_X]  in 1 mL
CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE)	CONVALLARIA MAJALIS	3 [hp_X]  in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	3 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	3 [hp_X]  in 1 mL
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	5 [hp_X]  in 1 mL
NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) (NERIUM OLEANDER LEAF - UNII:7KV510R6H6)	NERIUM OLEANDER LEAF	8 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X]  in 1 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	30 [hp_C]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0321-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/18/2014	08/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/18/2014	08/11/2019

Labeler - BioActive Nutritional, Inc (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0321) , api manufacture(43857-0321) , label(43857-0321) , pack(43857-0321)

Revised: 2/2018

Document Id: 19ffe8bb-5611-4486-aa1a-4fc6687dff56

34390-5

Set id: a4dc5b61-d008-453d-9149-456547338a2b

Version: 2

Effective Time: 20180228