Allergen

Manufacturer
BioActive Nutritional | Apotheca Company
Effective date
2026-03-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:37:50

Label at a glance#

ProductAllergen I
Active ingredientPOTASSIUM GLUCONATE, BOS TAURUS ADRENAL GLAND, HEPARIN, BOVINE, ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, BITTER ALMOND, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM WHOLE, GREEN PEPPERCORN, EGGPLANT, CANOLA OIL, FLAX SEED, SESAME SEED, CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED, COW MILK, BEEF, LAMB, PORK, CHICKEN, EGG, KIDNEY BEAN, ONION, APPLE, WHEAT, BANANA, FRAGARIA VESCA FRUIT, ORANGE, ATLANTIC COD, NORTHERN BLUEFIN TUNA, ATLANTIC SALMON, EDIBLE ROCK CRAB, PACIFIC OYSTER, CRANGON SHRIMP, CORTISONE ACETATE, HISTAMINE DIHYDROCHLORIDE, HYALURONIDASE (BOVINE), INTERLEUKIN-1 .BETA. HUMAN, SEROTONIN HYDROCHLORIDE
Label structure9 sections

Indications and 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.

Dosage and administration

• 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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:

OTC - PURPOSE SECTION

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:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 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:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

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

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

ALLERGEN I

HOMEOPATHIC

1 fl oz (30 mL)

ALLERGEN IALLERGEN I

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0626-12024-10-02C16284748780-11030e365-5f18-111a-e063-dadaa90a10e2DRUG FACTS:
43857-0626-12024-01-30C16284748780-11030e365-5f18-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0626-1AllergenI30 mL in 1 BOTTLE, DROPPERLIQUID303

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 57 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-062643857-0626-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 49 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergen IPOTASSIUM 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),BioActive Nutritional25e10444-a2cc-4f74-bf38-9852c273e5ca2026-03-06WarningsExact identifier
ndc (package): 43857-0626-1
ndc (product): 43857-0626
ndc11 (package): 43857062601
spl id: 703834c0-4323-4295-b9e6-6c539075de0c
spl set id: 25e10444-a2cc-4f74-bf38-9852c273e5ca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.