SOMINEZE- humulus lupulus, passiflora incarnata, valeriana officinalis, ambrosia artemisiaefolia, arsenicum album, coffea tosta, lycopodium clavatum, nux vomica, phosphoricum acidum, silicea liquid 
BioActive Nutritional, 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.

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Drug Facts:

ACTIVE INGREDIENTS:

Humulus Lupulus 3X, Passiflora Incarnata 3X, Valeriana Officinalis 3X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Coffea Tosta 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Silicea 12X.

INDICATIONS:

For temporary relief of fatigue, insomnia with restlessness of the legs, irritability, light sleep with drowsiness in the morning.

WARNINGS:

If pregnant or breast-feeding, ask a health care 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 cool, dry place.

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:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of fatigue, insomnia with restlessness of the legs, irritability, light sleep with drowsiness in the morning.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

SOMINEZE

HOMEOPATHIC

1 FL OZ (30 ml)

Somineze

SOMINEZE 
humulus lupulus, passiflora incarnata, valeriana officinalis, ambrosia artemisiaefolia, arsenicum album, coffea tosta, lycopodium clavatum, nux vomica, phosphoricum acidum, silicea liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0379
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS3 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 1 mL
AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA12 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0379-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/14/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/14/2015
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0379) , api manufacture(43857-0379) , label(43857-0379) , pack(43857-0379)

Revised: 3/2018
Document Id: 4ab87088-52c2-4ea7-af56-069ffd566cb1
Set id: c0f80b84-0dd5-416b-abdf-8a0412e0b40b
Version: 3
Effective Time: 20180313
 
BioActive Nutritional, Inc.