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.

----------

Drug Facts:

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 3X, Hydrastis Canadensis 6X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

INDICATIONS:

May temporarily relieve minor throat pain, swollen sensation 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 minor throat pain, swollen sensation 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

1 fl. oz. (30 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:44911-0401
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [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 (UNII: 86H4S6K51N) (THYMUS SERPYLLUM - UNII:86H4S6K51N) THYMUS SERPYLLUM2 [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 ROOT3 [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:44911-0401-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/13/201612/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/13/201612/30/2021
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0401) , api manufacture(44911-0401) , label(44911-0401) , pack(44911-0401)

Revised: 5/2018
 
Energique, Inc.