ALLERGEN I- potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, cortisone aceticum, histaminum hydrochloricum, hyaluronidase, interferon (suis), serotonin hydrochloride, allium cepa, amygdala amara, anacardium occidentale, banana, beef, black walnut, brazil nus, cheese, chicken, coconut, coc, egg, eggplant, juglans regia, flax, fragaria vesca, lac vaccinum, lamb, levant cotton, limulus, lycopersicum esculentum, liquid 
BioActive Nutritional, Inc.

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.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Potassium Gluconate 6X, Glandula Suprarenalis Bovinum 8X, Hepar Bovinum 8X, Arsenicum Album 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X, Onion 12X, 30X, Amygdala Amara 12X, 30X, Anacardium Occidentale 12X, 30X, Banana 12X, 30X, Beef 12X, 30X, Black walnut 12X, 30X, Brazil nut 12X, 30X, Cheese 12X, 30X, Chicken 12X, 30X, Coconut 12X, 30X, Cod 12X, 30X, Egg 12X, 30X, Eggplant 12X, 30X, Juglans Regia 12X, 30X,  Flax 12X, 30X, Fragaria Vesca 2X, 30X, Lac Vaccinum 12X, 30C, Lamb 12X, 30X, Levant cotton 12X, 30X, Limulus 12X, 30X, Lycopersicum Esculentum 12X, 30X, Malus Pumila Flos 12X, 30X, Orange 12X, 30X, Oyster 12X, 30X, Peanut 12X, 30X, Pecan 12X, 30X, Pepper 12X, 30X, Phaseolus 12X, 30X, Potato 12X, 30X, Pork 12X, 30X, Salmon 12X, 30X, Sesame 12X, 30X, Shrimp 12X, 30X, Tuna 12X, 30X, Wheat 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 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. Consult a physician for use in children under 12 years of age.

INDICATIONS AND USAGE

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

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

*For a complete list of Allersode contact BioActive Nutritional, Inc.

BioActive Homeopathic

ALLERGEN I

1 FL OZ (30 ml)

Allergen I

ALLERGEN  I
potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, cortisone aceticum, histaminum hydrochloricum, hyaluronidase, interferon (suis), serotonin hydrochloride, allium cepa, amygdala amara, anacardium occidentale, banana, beef, black walnut, brazil nus, cheese, chicken, coconut, coc, egg, eggplant, juglans regia, flax, fragaria vesca, lac vaccinum, lamb, levant cotton, limulus, lycopersicum esculentum, liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0038
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
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION12 [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
BANANA (UNII: 4AJZ4765R9) (BANANA - UNII:4AJZ4765R9) BANANA12 [hp_X]  in 1 mL
BEEF (UNII: 4PIB2155QP) (BEEF - UNII:4PIB2155QP) BEEF12 [hp_X]  in 1 mL
BLACK WALNUT (UNII: 02WM57RXZJ) (BLACK WALNUT - UNII:02WM57RXZJ) BLACK WALNUT12 [hp_X]  in 1 mL
BRAZIL NUT (UNII: XKR79OET1K) (BRAZIL NUT - UNII:XKR79OET1K) BRAZIL NUT12 [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
CHICKEN (UNII: 0X8Q245Y7B) (CHICKEN - UNII:0X8Q245Y7B) CHICKEN12 [hp_X]  in 1 mL
COCONUT (UNII: 3RT3536DHY) (COCONUT - UNII:3RT3536DHY) COCONUT12 [hp_X]  in 1 mL
PACIFIC COD (UNII: ILA0LAH43W) (PACIFIC COD - UNII:ILA0LAH43W) PACIFIC COD12 [hp_X]  in 1 mL
EGG (UNII: 291P45F896) (EGG - UNII:291P45F896) EGG12 [hp_X]  in 1 mL
EGGPLANT (UNII: W5K7RAS4VK) (EGGPLANT - UNII:W5K7RAS4VK) EGGPLANT12 [hp_X]  in 1 mL
ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT12 [hp_X]  in 1 mL
FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C) FLAX SEED12 [hp_X]  in 1 mL
ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY12 [hp_X]  in 1 mL
COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK12 [hp_X]  in 1 mL
LAMB (UNII: FOF26T73HA) (LAMB - UNII:FOF26T73HA) LAMB12 [hp_X]  in 1 mL
LEVANT COTTON SEED (UNII: 550E4N439V) (LEVANT COTTON SEED - UNII:550E4N439V) LEVANT COTTON SEED12 [hp_X]  in 1 mL
LIMULUS POLYPHEMUS (UNII: 3R8874KEYH) (LIMULUS POLYPHEMUS - UNII:3R8874KEYH) LIMULUS POLYPHEMUS12 [hp_X]  in 1 mL
TOMATO (UNII: Z4KHF2C175) (TOMATO - UNII:Z4KHF2C175) TOMATO12 [hp_X]  in 1 mL
MALUS DOMESTICA FLOWER (UNII: EF626V855K) (MALUS DOMESTICA FLOWER - UNII:EF626V855K) MALUS DOMESTICA FLOWER12 [hp_X]  in 1 mL
ORANGE (UNII: 5EVU04N5QU) (ORANGE - UNII:5EVU04N5QU) ORANGE12 [hp_X]  in 1 mL
OYSTER, UNSPECIFIED (UNII: S614XWR17V) (OYSTER, UNSPECIFIED - UNII:S614XWR17V) OYSTER, UNSPECIFIED12 [hp_X]  in 1 mL
PEANUT (UNII: QE1QX6B99R) (PEANUT - UNII:QE1QX6B99R) PEANUT12 [hp_X]  in 1 mL
PECAN (UNII: F14P91GB5F) (PECAN - UNII:F14P91GB5F) PECAN12 [hp_X]  in 1 mL
BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER12 [hp_X]  in 1 mL
KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO) KIDNEY BEAN12 [hp_X]  in 1 mL
POTATO (UNII: CFE1S8DYWD) (POTATO - UNII:CFE1S8DYWD) POTATO12 [hp_X]  in 1 mL
PORK (UNII: O138UB266J) (PORK - UNII:O138UB266J) PORK12 [hp_X]  in 1 mL
SALMON, UNSPECIFIED (UNII: 6122W2M0GB) (SALMON, UNSPECIFIED - UNII:6122W2M0GB) SALMON, UNSPECIFIED12 [hp_X]  in 1 mL
SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR) SESAME SEED12 [hp_X]  in 1 mL
SHRIMP, UNSPECIFIED (UNII: 1891LE191T) (SHRIMP, UNSPECIFIED - UNII:1891LE191T) SHRIMP, UNSPECIFIED12 [hp_X]  in 1 mL
TUNA, UNSPECIFIED (UNII: V2T3IHT3E2) (TUNA, UNSPECIFIED - UNII:V2T3IHT3E2) TUNA, UNSPECIFIED12 [hp_X]  in 1 mL
WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT12 [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:43857-0038-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/17/201312/11/2017
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Comany (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0038) , api manufacture(43857-0038) , label(43857-0038) , pack(43857-0038)

Revised: 6/2015
Document Id: 7708a79f-d170-4a69-b95d-26c5a250f2a4
Set id: 4908bcf8-e1a5-4a62-9977-71e7a0dd89cc
Version: 2
Effective Time: 20150609
 
BioActive Nutritional, Inc.