HEART/FATIGUE (spigelia anthelmia, kali carbonicum, arnica montana, cactus grandiflorus, gelsemium sempervirens, castoreum, glonoinum, ranunculus bulbosus, heart- suis, abrotanum, sulphur liquid

Heart/Fatigue by

Drug Labeling and Warnings

Heart/Fatigue by is a Homeopathic medication manufactured, distributed, or labeled by Deseret Biologicals, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Spigelia Anthelmia 2X, Kali Carbonicum 3X, Arnica Montana 4X, Cactus Grandiflorus 4X, Gelsemium Sempervirens 4X, Castoreum 6X, Glonoinum 6X, Ranunculus Bulbosus 6X, Heart (Suis) 8X, Abrotanum 12X, Sulphur 12X.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to circulatory and heart dysfunction including insomnia, fatigue, and night time restlessness.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to circulatory and heart dysfunction including insomnia, fatigue, and night time restlessness.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

QUESTIONS:

Dist By:

Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC: 43742-0846-1

HOMEOPATHIC

HEART/FATIGUE

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

HEART/FATIGUE 
spigelia anthelmia, kali carbonicum, arnica montana, cactus grandiflorus, gelsemium sempervirens, castoreum, glonoinum, ranunculus bulbosus, heart (suis), abrotanum, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43742-0846
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	2 [hp_X]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	3 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	4 [hp_X]  in 1 mL
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK)	SELENICEREUS GRANDIFLORUS STEM	4 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]  in 1 mL
CASTOR CANADENSIS SCENT GLAND SECRETION (UNII: D0MH91LS9C) (CASTOR CANADENSIS SCENT GLAND SECRETION - UNII:D0MH91LS9C)	CASTOR CANADENSIS SCENT GLAND SECRETION	6 [hp_X]  in 1 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	6 [hp_X]  in 1 mL
RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB)	RANUNCULUS BULBOSUS	6 [hp_X]  in 1 mL
PORK HEART (UNII: X876KJM95L) (PORK HEART - UNII:X876KJM95L)	PORK HEART	8 [hp_X]  in 1 mL
ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0)	ARTEMISIA ABROTANUM FLOWERING TOP	12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  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: 43742-0846-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/12/2016	10/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/12/2016	10/03/2021

Labeler - Deseret Biologicals, Inc. (940741853)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43742-0846) , api manufacture(43742-0846) , label(43742-0846) , pack(43742-0846)