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

Allergen by

Drug Labeling and Warnings

Allergen by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Allium Cepa 12X, 30X, Amygdala Amara 12X, 30X, Apple 12X, 30X, Arsenicum Album 12X, Banana 12X, 30X, Beef 12X, 30X, Black Walnut 12X, 30X, Brazil Nut 12X, 30X, Cashew 12X, 30X, Cheese 12X, 30X, Chicken 12X, 30X, Coconut 12X, 30X, Cod 12X, 30X, Cortisone Aceticum 30X, Crab 12X, 30X, Egg 12X, 30X, Eggplant 12X, 30X, English Walnut 12X, 30X, Fragaria Vesca 12X, 30X, Glandula Suprarenalis Bovine 8X, Hepar Bovine 8X, Histaminum Hydrochloricum 30X, Hyaluronidase 30X, Interferon (Human) 30X, Lac Vaccinum 12X, 30X, Lamb 12X, 30X, Linum Usitatissimum 12X, 30X, Lycopodium Clavatum 12X, Nux Vomica 12X, Orange 12X, 30X, Oyster 12X, 30X, Peanut 12X, 30X, Pecan 12X, 30X, Phaseolus 12X, 30X, Phosphorus 12X, Piper Nigrum 12X, 30X, Pork 12X, 30X, Potassium Gluconate 6X, Rape Seed Oil 12X, 30X, Salmon 12X, 30X, Sesame Seed 12X, 30X, Serotonin 30X, Shrimp 12X, 30X, Solanum Tuberosum 12X, 30X, Tomato 12X, 30X, Tuna 12X, 30X, Wheat 12X, 30X.

PURPOSE:

Allium Cepa - flatulence,** Amygdala Amara – bloating, indigestion,** Apple – food intolerance,** Arsenicum Album – gastrointestinal disturbances,** Banana – food intolerance,** Beef - food intolerance,** Black Walnut - food intolerance,** Brazil Nut - food intolerance,** Cashew - food intolerance,** Cheese - food intolerance,** Chicken - food intolerance,** Coconut - food intolerance,** Cod - food intolerance,** Cortisone Aceticum – anti-inflammatory,** Crab - food intolerance,** Egg - food intolerance,** Eggplant - food intolerance,** English Walnut - food intolerance,** Fragaria Vesca - food intolerance,** Glandula Suprarenalis Bovine – stomach cramps,** Hepar Bovine – support of liver,** Histaminum Hydrochloricum - diarrhea,** Hyaluronidase – sensitivity to food,** Interferon (Human) – sensitivity to food,** Lac Vaccinum - food intolerance,** Lamb - food intolerance,** Linum Usitatissimum - food intolerance,** Lycopodium Clavatum - indigestion,** Nux Vomica – abdominal pain,** Orange - food intolerance,** Oyster - food intolerance,** Peanut - food intolerance,** Pecan - food intolerance,** Phaseolus - food intolerance,** Phosphorus – burning stomach pain,** Piper Nigrum - food intolerance,** Pork - food intolerance,** Potassium Gluconate – stomach cramps,** Rape Seed Oil – food intolerance,** Salmon - food intolerance,** Sesame Seed - food intolerance,** Serotonin – sensitivity to food,** Shrimp – food intolerance,** Solanum Tuberosum - food intolerance,** Tomato - food intolerance,** Tuna - food intolerance,** Wheat - food intolerance**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

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

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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:

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

10 drops orally, 3 times a day or as directed by a health care professional.

Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

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

1-800-288-9525

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

ALLERGEN I

HOMEOPATHIC

1 fl oz (30 mL)

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0626
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
HEPARIN, BOVINE (UNII: P776JQ4R2F) (HEPARIN, BOVINE - UNII:P776JQ4R2F)	HEPARIN, BOVINE	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
BITTER ALMOND (UNII: O65SFW8R9A) (BITTER ALMOND - UNII:O65SFW8R9A)	BITTER ALMOND	12 [hp_X]  in 1 mL
CASHEW (UNII: 3H5U5CX7KO) (CASHEW - UNII:3H5U5CX7KO)	CASHEW	12 [hp_X]  in 1 mL
COCONUT (UNII: 3RT3536DHY) (COCONUT - UNII:3RT3536DHY)	COCONUT	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
SOLANUM TUBEROSUM WHOLE (UNII: 2A8I57T4MX) (SOLANUM TUBEROSUM WHOLE - UNII:2A8I57T4MX)	SOLANUM TUBEROSUM WHOLE	12 [hp_X]  in 1 mL
GREEN PEPPERCORN (UNII: 6G53L8ESRK) (GREEN PEPPERCORN - UNII:6G53L8ESRK)	GREEN PEPPERCORN	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
FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C)	FLAX SEED	12 [hp_X]  in 1 mL
SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR)	SESAME SEED	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
FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU)	FRAGARIA VESCA FRUIT	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
CRANGON SHRIMP (UNII: G1ZD4XB2AH) (CRANGON SHRIMP - UNII:G1ZD4XB2AH)	CRANGON 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 (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. HUMAN	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: 43857-0626-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/15/2022

Labeler - BioActive Nutritional (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0626) , api manufacture(43857-0626) , label(43857-0626) , pack(43857-0626)