Label: THROAT SPRAY- TONE- apis mellifica, baptisia tinctoria, belladonna, calendula officinalis, hepar sulphuris calcareum, hydrastis canadensis, lachesis mutus, mercurius solubilis, myrrha, phytolacca decandra, spilanthes oleracea. liquid
- NDC Code(s): 64578-0141-1
- Packager: Energetix Corporation
- 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 December 11, 2024
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ACTIVE INGREDIENT
Active ingredients 59.1 mL contains 9% of: Apis mel 12X; Baptisia 4X; Belladonna 12X; Calendula officinalis 4X; Hepar sulph calc 15X; Hydrastis 5X; Lachesis 12X; Merc solub 12X; Myrrha 5X; Phytolacca 4X; Spilanthes 5X.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
- INDICATIONS & USAGE
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WARNINGS
Warnings
- Sore throat 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 a physician.
- In case of overdose, get medical help or contact a Poison Control Center right away.
- If pregnant or breast feeding, ask a healthcare professional before use.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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INGREDIENTS AND APPEARANCE
THROAT SPRAY- TONE
apis mellifica, baptisia tinctoria, belladonna, calendula officinalis, hepar sulphuris calcareum, hydrastis canadensis, lachesis mutus, mercurius solubilis, myrrha, phytolacca decandra, spilanthes oleracea. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64578-0141 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 12 [hp_X] in 59.1 mL BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA 4 [hp_X] in 59.1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 12 [hp_X] in 59.1 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 4 [hp_X] in 59.1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 15 [hp_X] in 59.1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 5 [hp_X] in 59.1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 12 [hp_X] in 59.1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 12 [hp_X] in 59.1 mL MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH 5 [hp_X] in 59.1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 4 [hp_X] in 59.1 mL ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53) (ACMELLA OLERACEA FLOWERING TOP - UNII:1O11RD9U53) ACMELLA OLERACEA FLOWERING TOP 5 [hp_X] in 59.1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) THYMUS SERPYLLUM (UNII: 86H4S6K51N) CLOVE (UNII: K48IKT5321) MENTHA PIPERITA (UNII: 79M2M2UDA9) SAGE (UNII: 065C5D077J) ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64578-0141-1 59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/03/2017 Labeler - Energetix Corporation (969572502)