THROATSPRAY (echinacea- angustifolia, eugenia caryophyllata, glycerinum, myrrha, salvia officinalis, spilanthes oleracea, thymus serpyllum, baptisia tinctoria, phytolacca decandra, hydrastis canadensis, apis mellifica, belladonna, lachesis mutus, mercurius solubilis, hepar sulphuris calcareum spray

ThroatSpray by

Drug Labeling and Warnings

ThroatSpray by is a Homeopathic medication manufactured, distributed, or labeled by Energique, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Echinacea (Angustifolia) 1X, Eugenia Caryophyllata 1X, Glycerinum 1X, Myrrha 2X, Salvia Officinalis 2X, Spilanthes Oleracea 2X, Thymus Serpyllum 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 6X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

INDICATIONS:

May temporarily relieve swollen sensation, throat pain, and burning of the throat.**

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

WARNINGS:

If pregnant or breastfeeding, ask a health 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.

Warning - Severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

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:

Adults and children spray orally 4-6 times daily or as otherwise directed by a health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily relieve swollen sensation, throat pain, and burning of the throat.**

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

INACTIVE INGREDIENTS:

Demineralized Water, 20% Ethanol, Glycerin

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579  800.868.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

THROAT

SPRAY

2 fl. oz. (60 ml)

INGREDIENTS AND APPEARANCE

THROATSPRAY 
echinacea (angustifolia), eugenia caryophyllata, glycerinum, myrrha, salvia officinalis, spilanthes oleracea, thymus serpyllum, baptisia tinctoria, phytolacca decandra, hydrastis canadensis, apis mellifica, belladonna, lachesis mutus, mercurius solubilis, hepar sulphuris calcareum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0450
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	1 [hp_X]  in 1 mL
CLOVE (UNII: K48IKT5321) (CLOVE - UNII:K48IKT5321)	CLOVE	1 [hp_X]  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1 [hp_X]  in 1 mL
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)	MYRRH	2 [hp_X]  in 1 mL
SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J)	SAGE	2 [hp_X]  in 1 mL
ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53) (ACMELLA OLERACEA FLOWERING TOP - UNII:1O11RD9U53)	ACMELLA OLERACEA FLOWERING TOP	2 [hp_X]  in 1 mL
THYMUS SERPYLLUM (UNII: 86H4S6K51N) (THYMUS SERPYLLUM - UNII:86H4S6K51N)	THYMUS SERPYLLUM	2 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	12 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	15 [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: 44911-0450-1	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/13/2018

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0450) , api manufacture(44911-0450) , label(44911-0450) , pack(44911-0450)