Label: BIO IMMUNE- chelidonium majus, lobelia inflata, rumex crispus, sambucus nigra, scrophularia nodosa, senega officinalis, spongia tosta, taraxacum officinale, myristica sebifera, sticta pulmonaria, sulphur, ustilago maidis, polyporus officinalis, candida albicans, carduus marianus, crotalus horridus, agaricus muscarius, bovista, secale cornutum, anas barbariae, hepatis et cordis extractum, anthracinum, arsenicum album, baptisia tinctoria, berberis vulgaris, botulinum, dysentery bacillus, gaertner bacillus liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 44911-0269-1 - Packager: Energique, 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 December 22, 2016
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ACTIVE INGREDIENTS:
Chelidonium Majus, Lobelia Inflata, Rumex Crispus, Sambucus Nigra, Scrophularia Nodosa, Senega Officinalis, Spongia Tosta, Taraxacum Officinale 3X. Myristica Sebifera, Sticta Pulmonaria, Sulphur, Ustilago Maidis 6X. Polyporus Officinalis, Candida Albicans, Carduus Marianus, Crotalus Horridus 12X. Agaricus Muscarius, Bovista, Secale Cornutum 10C. Anas Barbariae, Hepatis Et Cordis Extractum, Anthracinum, Arsenicum Album, Baptisia Tinctoria, Berberis Vulgaris, Botulinum, Dysentery Bacillus, Gaertner Bacillus, Influenzinum, Malandrinum, Pertussinum, Pneumococcinum, Pyrogenium, Variolinum 30C.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
BIO IMMUNE
chelidonium majus, lobelia inflata, rumex crispus, sambucus nigra, scrophularia nodosa, senega officinalis, spongia tosta, taraxacum officinale, myristica sebifera, sticta pulmonaria, sulphur, ustilago maidis, polyporus officinalis, candida albicans, carduus marianus, crotalus horridus, agaricus muscarius, bovista, secale cornutum, anas barbariae, hepatis et cordis extractum, anthracinum, arsenicum album, baptisia tinctoria, berberis vulgaris, botulinum, dysentery bacillus, gaertner bacillus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0269 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 3 [hp_X] in 1 mL LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA 3 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 3 [hp_X] in 1 mL SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X] in 1 mL SCROPHULARIA NODOSA (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA - UNII:7H443NUB2T) SCROPHULARIA NODOSA 3 [hp_X] in 1 mL POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF) POLYGALA SENEGA ROOT 3 [hp_X] in 1 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 3 [hp_X] in 1 mL VIROLA SEBIFERA RESIN (UNII: GHJ5XX5SGS) (VIROLA SEBIFERA RESIN - UNII:GHJ5XX5SGS) VIROLA SEBIFERA RESIN 6 [hp_X] in 1 mL LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] in 1 mL USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 6 [hp_X] in 1 mL LARICIFOMES OFFICINALIS FRUITING BODY (UNII: 7IFM8431X3) (LARICIFOMES OFFICINALIS FRUITING BODY - UNII:7IFM8431X3) LARICIFOMES OFFICINALIS FRUITING BODY 8 [hp_X] in 1 mL CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 12 [hp_X] in 1 mL MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE 12 [hp_X] in 1 mL CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM 12 [hp_X] in 1 mL AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY 10 [hp_C] in 1 mL LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F) LYCOPERDON UTRIFORME FRUITING BODY 10 [hp_C] in 1 mL CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM 10 [hp_C] in 1 mL CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE (UNII: RN2HC612GY) (CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - UNII:RN2HC612GY) CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 30 [hp_C] in 1 mL BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N) BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] in 1 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 30 [hp_C] in 1 mL BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 30 [hp_C] in 1 mL BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (ABOBOTULINUMTOXINA - UNII:E211KPY694) BOTULINUM TOXIN TYPE A 30 [hp_C] in 1 mL SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (SHIGELLA DYSENTERIAE - UNII:1EP6R5562J) SHIGELLA DYSENTERIAE 30 [hp_C] in 1 mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS - UNII:Y3V16D4PV4) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 30 [hp_C] in 1 mL INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA A VIRUS 30 [hp_C] in 1 mL INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA B VIRUS - UNII:1314JZ2X6W) INFLUENZA B VIRUS 30 [hp_C] in 1 mL VACCINIA VIRUS (UNII: JDS6958QAG) (VACCINIA VIRUS - UNII:JDS6958QAG) VACCINIA VIRUS 30 [hp_C] in 1 mL HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED (UNII: U364V64HUN) (HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - UNII:U364V64HUN) HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED 30 [hp_C] in 1 mL STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2) STREPTOCOCCUS PNEUMONIAE 30 [hp_C] in 1 mL RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF 30 [hp_C] in 1 mL VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN (UNII: 4SV59689SK) (VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN - UNII:4SV59689SK) VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 30 [hp_C] 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:44911-0269-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/28/2015 10/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/24/2015 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0269) , api manufacture(44911-0269) , label(44911-0269) , pack(44911-0269)
