Allergen

Manufacturer
BioActive Nutritional | Apotheca Company
Effective date
2022-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:59:04

Label at a glance#

ProductAllergen I
Active ingredientPOTASSIUM GLUCONATE, BOS TAURUS ADRENAL GLAND, BEEF LIVER, ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, ALMOND, CASHEW, PECAN, BRAZIL NUT, TOMATO, POTATO, BLACK PEPPER, EGGPLANT, CANOLA OIL, CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED, COW MILK, BEEF, LAMB, PORK, CHICKEN, EGG, KIDNEY BEAN, ONION, APPLE, WHEAT, BANANA, STRAWBERRY, ORANGE, ATLANTIC COD, NORTHERN BLUEFIN TUNA, ATLANTIC SALMON, EDIBLE ROCK CRAB, PACIFIC OYSTER, COMMON SHRIMP, CORTISONE ACETATE, HISTAMINE DIHYDROCHLORIDE, HYALURONIDASE, INTERFERON .GAMMA. PORCINE RECOMBINANT, SEROTONIN HYDROCHLORIDE
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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, Almond 12X, 30X, Cashew 12X, 30X,  Pecan 12X, 30X, Brazil Nut 12X, 30X, Tomato 12X, 30X, Potato (Solanum Tuberosum) 12X, 30X, Black Pepper 12X, 30X, Eggplant (Solanum Melongena) 12X, 30X, Rape Seed Oil 12X, 30X, Cheese (Stilton) 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, Strawberry 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:

OTC - PURPOSE SECTION

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

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

Keep out of reach of children. 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. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

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

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

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

ALLERGEN I

HOMEOPATHIC

1 FL OZ (30 ml)

ALLERGEN IALLERGEN I

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0526-12022-05-24C16284748780-1d6a99b39-6bb5-a426-e053-dadaa90af4c2Drug Facts:
43857-0526-12022-01-28C16284748780-1d6a99b39-6bb5-a426-e053-dadaa90af4c2Drug Facts:

Products#

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

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-052643857-0526-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 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
8b507a8e-a00d-4c32-bcbc-ccadabd597ef9183d3be-f3f6-47b3-b98f-ea71213574f52022-06-20WarningsExact identifier
spl id: 8b507a8e-a00d-4c32-bcbc-ccadabd597ef
spl set id: 9183d3be-f3f6-47b3-b98f-ea71213574f5

Reported adverse events (FAERS/openFDA)#

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