Label: HEADACHE TONIC (carduus marianus, pyrethrum parthenium, secale cornutum, aconitum napellus, belladonna, bryonia- alba, gelsemium sempervirens, glonoinum, melilotus officinalis, nux vomica, sepia, spigelia anthelmia liquid
- NDC Code(s): 43857-0507-1
- Packager: BioActive Nutritional, 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 October 17, 2024
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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INGREDIENTS AND APPEARANCE
HEADACHE TONIC
carduus marianus, pyrethrum parthenium, secale cornutum, aconitum napellus, belladonna, bryonia (alba), gelsemium sempervirens, glonoinum, melilotus officinalis, nux vomica, sepia, spigelia anthelmia liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0507 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE 1 [hp_X] in 1 mL TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K) (TANACETUM PARTHENIUM - UNII:6GE7Z0761K) TANACETUM PARTHENIUM WHOLE 6 [hp_X] in 1 mL CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM 6 [hp_X] in 1 mL ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 12 [hp_X] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 12 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 12 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 12 [hp_X] in 1 mL NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 12 [hp_X] in 1 mL MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX) MELILOTUS OFFICINALIS TOP 12 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 12 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 12 [hp_X] in 1 mL SPIGELIA ANTHELMIA WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE 12 [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:43857-0507-1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/30/2019 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0507, 43857-0507) , api manufacture(43857-0507) , pack(43857-0507)