Label: ALLERGEN I (potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, peanut, black walnut, english walnut, almond, cashew, pecan, brazil nut, tomato, potato (solanum tuberosum), black pepper, eggplant (solanum melongena), rape seed oil, cheese (stilton), lac vaccinum, beef, lamb, pork, chicken, egg (whole), phaseolus, allium cepa, apple, wheat, banana, strawberry, orange, cod (gadus morhua), tuna- thunnus thynnus, liquid
- NDC Code(s): 43857-0526-1
- Packager: BioActive Nutritional
- 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 June 20, 2022
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ACTIVE INGREDIENTS:
Potassium Gluconate 6X, Glandula Suprarenalis Bovine 8X, Hepar Bovine 8X, Arsenicum Album 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X, Peanut 12X, 30X, Black Walnut 12X, 30X, English Walnut 12X, 30X, Almond 12X, 30X, Cashew 12X, 30X, Pecan 12X, 30X, Brazil Nut 12X, 30X, Tomato 12X, 30X, Potato (Solanum Tuberosum) 12X, 30X, Black Pepper 12X, 30X, Eggplant (Solanum Melongena) 12X, 30X, Rape Seed Oil 12X, 30X, Cheese (Stilton) 12X, 30X, Lac Vaccinum 12X, 30X, Beef 12X, 30X, Lamb 12X, 30X, Pork 12X, 30X, Chicken 12X, 30X, Egg (Whole) 12X, 30X, Phaseolus 12X, 30X, Allium Cepa 12X, 30X, Apple 12X, 30X, Wheat 12X, 30X, Banana 12X, 30X, Strawberry 12X, 30X, Orange 12X, 30X, Cod (Gadus Morhua) 12X, 30X, Tuna (Thunnus Thynnus) 12X, 30X, Salmon (Salmo Salar) 12X, 30X, Crab (Cancer Pagurus) 12X, 30X, Oyster (Crassostrea Gigas) 12X, 30X, Shrimp (Crangon Crangon) 12X, 30X, Cortisone Aceticum 30X, Histaminum Hydrochloricum 30X, Hyaluronidase 30X, Interferon (Human) 30X, Serotonin (Hydrochloride) 30X.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ALLERGEN I
potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, peanut, black walnut, english walnut, almond, cashew, pecan, brazil nut, tomato, potato (solanum tuberosum), black pepper, eggplant (solanum melongena), rape seed oil, cheese (stilton), lac vaccinum, beef, lamb, pork, chicken, egg (whole), phaseolus, allium cepa, apple, wheat, banana, strawberry, orange, cod (gadus morhua), tuna (thunnus thynnus), liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0526 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM GLUCONATE (UNII: 12H3K5QKN9) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM GLUCONATE 6 [hp_X] in 1 mL BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29) BOS TAURUS ADRENAL GLAND 8 [hp_X] in 1 mL BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER 8 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 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 PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL PEANUT (UNII: QE1QX6B99R) (PEANUT - UNII:QE1QX6B99R) PEANUT 12 [hp_X] in 1 mL BLACK WALNUT (UNII: 02WM57RXZJ) (BLACK WALNUT - UNII:02WM57RXZJ) BLACK WALNUT 12 [hp_X] in 1 mL ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT 12 [hp_X] in 1 mL ALMOND (UNII: 3Z252A2K9G) (ALMOND - UNII:3Z252A2K9G) ALMOND 12 [hp_X] in 1 mL CASHEW (UNII: 3H5U5CX7KO) (CASHEW - UNII:3H5U5CX7KO) CASHEW 12 [hp_X] in 1 mL PECAN (UNII: F14P91GB5F) (PECAN - UNII:F14P91GB5F) PECAN 12 [hp_X] in 1 mL BRAZIL NUT (UNII: XKR79OET1K) (BRAZIL NUT - UNII:XKR79OET1K) BRAZIL NUT 12 [hp_X] in 1 mL TOMATO (UNII: Z4KHF2C175) (TOMATO - UNII:Z4KHF2C175) TOMATO 12 [hp_X] in 1 mL POTATO (UNII: CFE1S8DYWD) (POTATO - UNII:CFE1S8DYWD) POTATO 12 [hp_X] in 1 mL BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER 12 [hp_X] in 1 mL EGGPLANT (UNII: W5K7RAS4VK) (EGGPLANT - UNII:W5K7RAS4VK) EGGPLANT 12 [hp_X] in 1 mL CANOLA OIL (UNII: 331KBJ17RK) (CANOLA OIL - UNII:331KBJ17RK) CANOLA OIL 12 [hp_X] in 1 mL CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED (UNII: IYI0G2057S) (CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED - UNII:IYI0G2057S) CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED 12 [hp_X] in 1 mL COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK 12 [hp_X] in 1 mL BEEF (UNII: 4PIB2155QP) (BEEF - UNII:4PIB2155QP) BEEF 12 [hp_X] in 1 mL LAMB (UNII: FOF26T73HA) (LAMB - UNII:FOF26T73HA) LAMB 12 [hp_X] in 1 mL PORK (UNII: O138UB266J) (PORK - UNII:O138UB266J) PORK 12 [hp_X] in 1 mL CHICKEN (UNII: 0X8Q245Y7B) (CHICKEN - UNII:0X8Q245Y7B) CHICKEN 12 [hp_X] in 1 mL EGG (UNII: 291P45F896) (EGG - UNII:291P45F896) EGG 12 [hp_X] in 1 mL KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO) KIDNEY BEAN 12 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 12 [hp_X] in 1 mL APPLE (UNII: B423VGH5S9) (APPLE - UNII:B423VGH5S9) APPLE 12 [hp_X] in 1 mL WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT 12 [hp_X] in 1 mL BANANA (UNII: 4AJZ4765R9) (BANANA - UNII:4AJZ4765R9) BANANA 12 [hp_X] in 1 mL STRAWBERRY (UNII: 4J2TY8Y81V) (STRAWBERRY - UNII:4J2TY8Y81V) STRAWBERRY 12 [hp_X] in 1 mL ORANGE (UNII: 5EVU04N5QU) (ORANGE - UNII:5EVU04N5QU) ORANGE 12 [hp_X] in 1 mL ATLANTIC COD (UNII: RPX7J99EXW) (ATLANTIC COD - UNII:RPX7J99EXW) ATLANTIC COD 12 [hp_X] in 1 mL NORTHERN BLUEFIN TUNA (UNII: 816CLQ4017) (NORTHERN BLUEFIN TUNA - UNII:816CLQ4017) NORTHERN BLUEFIN TUNA 12 [hp_X] in 1 mL ATLANTIC SALMON (UNII: 7062I37LB3) (ATLANTIC SALMON - UNII:7062I37LB3) ATLANTIC SALMON 12 [hp_X] in 1 mL EDIBLE ROCK CRAB (UNII: RLE491K17W) (EDIBLE ROCK CRAB - UNII:RLE491K17W) EDIBLE ROCK CRAB 12 [hp_X] in 1 mL PACIFIC OYSTER (UNII: FX2S0D3781) (PACIFIC OYSTER - UNII:FX2S0D3781) PACIFIC OYSTER 12 [hp_X] in 1 mL COMMON SHRIMP (UNII: 1U601HV1HW) (COMMON SHRIMP - UNII:1U601HV1HW) COMMON SHRIMP 12 [hp_X] in 1 mL CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 30 [hp_X] in 1 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 30 [hp_X] in 1 mL HYALURONIDASE (UNII: 8KOG53Z5EM) (HYALURONIDASE - UNII:8KOG53Z5EM) HYALURONIDASE 30 [hp_X] in 1 mL INTERFERON .GAMMA. PORCINE RECOMBINANT (UNII: 69404B0LO7) (INTERFERON .GAMMA. PORCINE RECOMBINANT - UNII:69404B0LO7) INTERFERON .GAMMA. PORCINE RECOMBINANT 30 [hp_X] in 1 mL SEROTONIN HYDROCHLORIDE (UNII: GKN429M9VS) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN HYDROCHLORIDE 30 [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:43857-0526-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/03/2020 12/09/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/02/2020 12/09/2024 Labeler - BioActive Nutritional (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0526) , api manufacture(43857-0526) , label(43857-0526) , pack(43857-0526)