Label: ALLERGEN I (potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, peanut, black walnut, english walnut, amygdala amara, cashew, coconut, pecan, brazil nut, tomato, solanum tuberosum, piper nigrum, eggplant (solanum melongena), rape seed oil, linum usitatissimum, sesame seed, cheese (stilton), lac vaccinum, beef, lamb, pork, chicken, egg (whole), phaseolus, allium cepa, apple, wheat, banana, strawberry, cod (gadus morhua), tuna- thunnus thynnus, liquid

  • 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 15, 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, Amygdala Amara 12X, 30X, Cashew 12X, 30X, Coconut 12X, 30X, Pecan 12X, 30X, Brazil Nut 12X, 30X, Tomato 12X, 30X, Solanum Tuberosum 12X, 30X, Piper Nigrum 12X, 30X, Eggplant (Solanum Melongena) 12X, 30X, Rape Seed Oil 12X, 30X, Cheese (Stilton) 12X, 30X, Linum Usitatissimum 12X, 30X, Sesame Seed 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, Fragaria Vesca 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:

    For temporary relief of gastrointestinal dyspepsia with flatulence and bloating, loss of weight and intolerance of certain foods.

  • 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 a 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 gastrointestinal dyspepsia with flatulence and bloating, loss of weight and intolerance of certain foods.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    ALLERGEN I

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Allergen I

  • INGREDIENTS AND APPEARANCE
    ALLERGEN  I
    potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, peanut, black walnut, english walnut, amygdala amara, cashew, coconut, pecan, brazil nut, tomato, solanum tuberosum, piper nigrum, eggplant (solanum melongena), rape seed oil, linum usitatissimum, sesame seed, cheese (stilton), lac vaccinum, beef, lamb, pork, chicken, egg (whole), phaseolus, allium cepa, apple, wheat, banana, strawberry, cod (gadus morhua), tuna (thunnus thynnus), liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0626
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM GLUCONATE (UNII: 12H3K5QKN9) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM GLUCONATE6 [hp_X]  in 1 mL
    BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29) BOS TAURUS ADRENAL GLAND8 [hp_X]  in 1 mL
    HEPARIN, BOVINE (UNII: P776JQ4R2F) (HEPARIN, BOVINE - UNII:P776JQ4R2F) HEPARIN, BOVINE8 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [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
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    PEANUT (UNII: QE1QX6B99R) (PEANUT - UNII:QE1QX6B99R) PEANUT12 [hp_X]  in 1 mL
    BLACK WALNUT (UNII: 02WM57RXZJ) (BLACK WALNUT - UNII:02WM57RXZJ) BLACK WALNUT12 [hp_X]  in 1 mL
    ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT12 [hp_X]  in 1 mL
    BITTER ALMOND (UNII: O65SFW8R9A) (BITTER ALMOND - UNII:O65SFW8R9A) BITTER ALMOND12 [hp_X]  in 1 mL
    CASHEW (UNII: 3H5U5CX7KO) (CASHEW - UNII:3H5U5CX7KO) CASHEW12 [hp_X]  in 1 mL
    COCONUT (UNII: 3RT3536DHY) (COCONUT - UNII:3RT3536DHY) COCONUT12 [hp_X]  in 1 mL
    PECAN (UNII: F14P91GB5F) (PECAN - UNII:F14P91GB5F) PECAN12 [hp_X]  in 1 mL
    BRAZIL NUT (UNII: XKR79OET1K) (BRAZIL NUT - UNII:XKR79OET1K) BRAZIL NUT12 [hp_X]  in 1 mL
    TOMATO (UNII: Z4KHF2C175) (TOMATO - UNII:Z4KHF2C175) TOMATO12 [hp_X]  in 1 mL
    SOLANUM TUBEROSUM WHOLE (UNII: 2A8I57T4MX) (SOLANUM TUBEROSUM WHOLE - UNII:2A8I57T4MX) SOLANUM TUBEROSUM WHOLE12 [hp_X]  in 1 mL
    GREEN PEPPERCORN (UNII: 6G53L8ESRK) (GREEN PEPPERCORN - UNII:6G53L8ESRK) GREEN PEPPERCORN12 [hp_X]  in 1 mL
    EGGPLANT (UNII: W5K7RAS4VK) (EGGPLANT - UNII:W5K7RAS4VK) EGGPLANT12 [hp_X]  in 1 mL
    CANOLA OIL (UNII: 331KBJ17RK) (CANOLA OIL - UNII:331KBJ17RK) CANOLA OIL12 [hp_X]  in 1 mL
    FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C) FLAX SEED12 [hp_X]  in 1 mL
    SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR) SESAME SEED12 [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, AGED12 [hp_X]  in 1 mL
    COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK12 [hp_X]  in 1 mL
    BEEF (UNII: 4PIB2155QP) (BEEF - UNII:4PIB2155QP) BEEF12 [hp_X]  in 1 mL
    LAMB (UNII: FOF26T73HA) (LAMB - UNII:FOF26T73HA) LAMB12 [hp_X]  in 1 mL
    PORK (UNII: O138UB266J) (PORK - UNII:O138UB266J) PORK12 [hp_X]  in 1 mL
    CHICKEN (UNII: 0X8Q245Y7B) (CHICKEN - UNII:0X8Q245Y7B) CHICKEN12 [hp_X]  in 1 mL
    EGG (UNII: 291P45F896) (EGG - UNII:291P45F896) EGG12 [hp_X]  in 1 mL
    KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO) KIDNEY BEAN12 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION12 [hp_X]  in 1 mL
    APPLE (UNII: B423VGH5S9) (APPLE - UNII:B423VGH5S9) APPLE12 [hp_X]  in 1 mL
    WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT12 [hp_X]  in 1 mL
    BANANA (UNII: 4AJZ4765R9) (BANANA - UNII:4AJZ4765R9) BANANA12 [hp_X]  in 1 mL
    FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) FRAGARIA VESCA FRUIT12 [hp_X]  in 1 mL
    ORANGE (UNII: 5EVU04N5QU) (ORANGE - UNII:5EVU04N5QU) ORANGE12 [hp_X]  in 1 mL
    ATLANTIC COD (UNII: RPX7J99EXW) (ATLANTIC COD - UNII:RPX7J99EXW) ATLANTIC COD12 [hp_X]  in 1 mL
    NORTHERN BLUEFIN TUNA (UNII: 816CLQ4017) (NORTHERN BLUEFIN TUNA - UNII:816CLQ4017) NORTHERN BLUEFIN TUNA12 [hp_X]  in 1 mL
    ATLANTIC SALMON (UNII: 7062I37LB3) (ATLANTIC SALMON - UNII:7062I37LB3) ATLANTIC SALMON12 [hp_X]  in 1 mL
    EDIBLE ROCK CRAB (UNII: RLE491K17W) (EDIBLE ROCK CRAB - UNII:RLE491K17W) EDIBLE ROCK CRAB12 [hp_X]  in 1 mL
    PACIFIC OYSTER (UNII: FX2S0D3781) (PACIFIC OYSTER - UNII:FX2S0D3781) PACIFIC OYSTER12 [hp_X]  in 1 mL
    CRANGON SHRIMP (UNII: G1ZD4XB2AH) (CRANGON SHRIMP - UNII:G1ZD4XB2AH) CRANGON SHRIMP12 [hp_X]  in 1 mL
    CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE30 [hp_X]  in 1 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE30 [hp_X]  in 1 mL
    HYALURONIDASE (BOVINE) (UNII: 8KOG53Z5EM) (HYALURONIDASE (BOVINE) - UNII:8KOG53Z5EM) HYALURONIDASE (BOVINE)30 [hp_X]  in 1 mL
    INTERLEUKIN-1 .BETA. HUMAN (UNII: X62226112J) (INTERLEUKIN-1 .BETA. HUMAN - UNII:X62226112J) INTERLEUKIN-1 .BETA. HUMAN30 [hp_X]  in 1 mL
    SEROTONIN HYDROCHLORIDE (UNII: GKN429M9VS) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN HYDROCHLORIDE30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0626-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/15/2022
    Labeler - BioActive Nutritional (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0626) , api manufacture(43857-0626) , label(43857-0626) , pack(43857-0626)
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