Label: FOOD ADDITIVES- berberis vulgaris, chelidonium majus, trifolium pratense, glycyrrhiza glabra, lappa major, phytolacca decandra, rhamnus frangula, rhamnus purshiana, stillingia sylvatica, xanthoxylum fraxineum, arsenicum album, belladonna, lycopodium clavatum, natrum sulphuricum, phosphoricum acidum liquid
- NDC Code(s): 43857-0168-1
- 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 September 28, 2016
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ACTIVE INGREDIENTS:
Berberis Vulgaris 3X, Chelidonium Majus 3X, Trifolium Pratense 3X, Glycyrrhiza Glabra 4X, Lappa Major 4X, Phytolacca Decandra 4X, Rhamnus Frangula 4X, Rhamnus Purshiana 4X, Stillingia Sylvatica 4X, Xanthoxylum Fraxineum 4X, Arsenicum Album 12X, Belladonna 12X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Phosphoricum Acidum 12X
- INDICATIONS:
- WARNINGS:
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- KEEP OUT OF REACH OF CHILDREN:
- INDICATIONS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
FOOD ADDITIVES
berberis vulgaris, chelidonium majus, trifolium pratense, glycyrrhiza glabra, lappa major, phytolacca decandra, rhamnus frangula, rhamnus purshiana, stillingia sylvatica, xanthoxylum fraxineum, arsenicum album, belladonna, lycopodium clavatum, natrum sulphuricum, phosphoricum acidum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0168 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 3 [hp_X] in 1 mL CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 3 [hp_X] in 1 mL TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER 3 [hp_X] in 1 mL GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA 4 [hp_X] in 1 mL ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT 4 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 4 [hp_X] in 1 mL FRANGULA ALNUS BARK (UNII: S2D77IH61R) (FRANGULA ALNUS BARK - UNII:S2D77IH61R) FRANGULA ALNUS BARK 4 [hp_X] in 1 mL FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F) FRANGULA PURSHIANA BARK 4 [hp_X] in 1 mL STILLINGIA SYLVATICA ROOT (UNII: QBR70R4FBK) (STILLINGIA SYLVATICA ROOT - UNII:QBR70R4FBK) STILLINGIA SYLVATICA ROOT 4 [hp_X] in 1 mL ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK 4 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE 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 SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 12 [hp_X] in 1 mL PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 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:43857-0168-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/28/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/16/2013 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0168) , api manufacture(43857-0168) , label(43857-0168) , pack(43857-0168)