Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 44911-0450-1 - Packager: Energique, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 Label Information
Updated March 14, 2022
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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:
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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:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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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 sprayProduct 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 WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 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 WHOLE (UNII: 86H4S6K51N) (THYMUS SERPYLLUM - UNII:86H4S6K51N) THYMUS SERPYLLUM WHOLE 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)
