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 
Energique, 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:

(in each spray): 6.67% of 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, minor throat pain, and burning of the throat.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 or 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, minor throat pain, and burning of the throat.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Demineralized Water, 20% Ethanol, Glycerin.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579  800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

THROAT

SPRAY

2 fl. oz. (60 ml)

Throat Spray

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0450
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE1 [hp_X]  in 1 mL
CLOVE (UNII: K48IKT5321) (CLOVE - UNII:K48IKT5321) CLOVE1 [hp_X]  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 [hp_X]  in 1 mL
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH2 [hp_X]  in 1 mL
SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE2 [hp_X]  in 1 mL
ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53) (ACMELLA OLERACEA FLOWERING TOP - UNII:1O11RD9U53) ACMELLA OLERACEA FLOWERING TOP2 [hp_X]  in 1 mL
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) (THYMUS SERPYLLUM - UNII:86H4S6K51N) THYMUS SERPYLLUM WHOLE2 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT3 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT4 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE15 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0450-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/13/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/13/2018
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0450) , api manufacture(44911-0450) , label(44911-0450) , pack(44911-0450)

Revised: 3/2022
Document Id: 25a6195f-83b7-4069-9d43-46c1687066e6
Set id: 3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c
Version: 2
Effective Time: 20220314
 
Energique, Inc.