Label: SOMINEZE- humulus lupulus, passiflora incarnata, valeriana officinalis, ambrosia artemisiaefolia, arsenicum album, coffea tosta, lycopodium clavatum, nux vomica, phosphoricum acidum, silicea liquid
- NDC Code(s): 43857-0379-1
- 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 March 13, 2018
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
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- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
SOMINEZE
humulus lupulus, passiflora incarnata, valeriana officinalis, ambrosia artemisiaefolia, arsenicum album, coffea tosta, lycopodium clavatum, nux vomica, phosphoricum acidum, silicea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0379 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 3 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] in 1 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 3 [hp_X] in 1 mL AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA 12 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED 12 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 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 PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 12 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 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:43857-0379-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 10/14/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/14/2015 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0379) , api manufacture(43857-0379) , label(43857-0379) , pack(43857-0379)