Label: ALLERGEN I- potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, peanut, black walnut, juglans regia, almond, cashew, coconut, pecan, brazil nut, lycopersicum esculentum, potato, black pepper, eggplant, gossypium herbaceum, flax, parmesan cheese, milk, beef, lamb, pork, chicken, egg, beans, allium cepa, malus pumila, flos, triticum aestivum, banana, fragaria vesca, citrus sinensis, cod, tuna, salmon, limulus, oyster, shrimp, cortisone aceticum 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 November 23, 2021

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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 Walnut12X, 30X, Juglans Regia 12X, 30X, Almond 12X, 30X, Cashew 12X, 30X, Coconut 12X, 30X, Pecan 12X, 30X, Brazil Nut 12X, 30X, Lycopersicum Esculentum 12X, 30X, Potato 12X, 30X, Black Pepper 12X, 30X, Eggplant 12X, 30X, Gossypium Herbaceum 12X, 30X, Flax 12X, 30X, Parmesan Cheese 12X, 30X, Milk 12X, 30X, Beef 12X, 30X, Lamb 12X, 30X, Pork 12X, 30X, Chicken 12X, 30X, Egg 12X, 30X, Beans 12X, 30X, Allium Cepa 12X, 30X, Malus Pumila, Flos 12X, 30X, Triticum Aestivum 12X, 30X, Banana 12X, 30X, Fragaria Vesca 12X, 30X, Citrus Sinensis 12X, 30X, Cod 12X, 30X, Tuna 12X, 30X, Salmon 12X, 30X, Limulus 12X, 30X, Oyster 12X, 30X, Shrimp 12X, 30X, Cortisone Aceticum 30X, Histaminum Hydrochloricum 30X, Hyaluronidase 30X, Interferon (Suis) 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, juglans regia, almond, cashew, coconut, pecan, brazil nut, lycopersicum esculentum, potato, black pepper, eggplant, gossypium herbaceum, flax, parmesan cheese, milk, beef, lamb, pork, chicken, egg, beans, allium cepa, malus pumila, flos, triticum aestivum, banana, fragaria vesca, citrus sinensis, cod, tuna, salmon, limulus, oyster, shrimp, cortisone aceticum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0241
    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
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER8 [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
    ALMOND (UNII: 3Z252A2K9G) (ALMOND - UNII:3Z252A2K9G) 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
    SOLANUM LYCOPERSICUM (UNII: 0243Q4990L) (SOLANUM LYCOPERSICUM - UNII:0243Q4990L) SOLANUM LYCOPERSICUM12 [hp_X]  in 1 mL
    POTATO (UNII: CFE1S8DYWD) (POTATO - UNII:CFE1S8DYWD) POTATO12 [hp_X]  in 1 mL
    BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER12 [hp_X]  in 1 mL
    EGGPLANT (UNII: W5K7RAS4VK) (EGGPLANT - UNII:W5K7RAS4VK) EGGPLANT12 [hp_X]  in 1 mL
    LEVANT COTTON SEED (UNII: 550E4N439V) (LEVANT COTTON SEED - UNII:550E4N439V) LEVANT COTTON SEED12 [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 (UNII: 489F5JNV5B) (CASEIN, LACTOCOCCUS LACTIS CULTURED - UNII:489F5JNV5B) CASEIN, LACTOCOCCUS LACTIS CULTURED12 [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
    MALUS PUMILA FLOWER (UNII: EF626V855K) (MALUS DOMESTICA FLOWER - UNII:EF626V855K) MALUS PUMILA FLOWER12 [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
    ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY12 [hp_X]  in 1 mL
    ORANGE (UNII: 5EVU04N5QU) (ORANGE - UNII:5EVU04N5QU) ORANGE12 [hp_X]  in 1 mL
    COD, UNSPECIFIED (UNII: 8D6Q5LNG3D) (COD, UNSPECIFIED - UNII:8D6Q5LNG3D) COD, UNSPECIFIED12 [hp_X]  in 1 mL
    TUNA, UNSPECIFIED (UNII: V2T3IHT3E2) (TUNA, UNSPECIFIED - UNII:V2T3IHT3E2) TUNA, UNSPECIFIED12 [hp_X]  in 1 mL
    SALMON, UNSPECIFIED (UNII: 6122W2M0GB) (SALMON, UNSPECIFIED - UNII:6122W2M0GB) SALMON, UNSPECIFIED12 [hp_X]  in 1 mL
    LIMULUS POLYPHEMUS (UNII: 3R8874KEYH) (LIMULUS POLYPHEMUS - UNII:3R8874KEYH) LIMULUS POLYPHEMUS12 [hp_X]  in 1 mL
    OYSTER, UNSPECIFIED (UNII: S614XWR17V) (OYSTER, UNSPECIFIED - UNII:S614XWR17V) OYSTER, UNSPECIFIED12 [hp_X]  in 1 mL
    SHRIMP, UNSPECIFIED (UNII: 1891LE191T) (SHRIMP, UNSPECIFIED - UNII:1891LE191T) SHRIMP, UNSPECIFIED12 [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 (UNII: 8KOG53Z5EM) (HYALURONIDASE - UNII:8KOG53Z5EM) HYALURONIDASE30 [hp_X]  in 1 mL
    INTERFERON .GAMMA. PORCINE RECOMBINANT (UNII: 69404B0LO7) (INTERFERON .GAMMA. PORCINE RECOMBINANT - UNII:69404B0LO7) INTERFERON .GAMMA. PORCINE RECOMBINANT30 [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:43857-0241-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/30/201711/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/26/201311/16/2023
    Labeler - BioActive Nutritional (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0241) , api manufacture(43857-0241) , label(43857-0241) , pack(43857-0241)
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