DAIRY ANTIGENS- american cheese, blue cheese, brie cheese, cheddar cheese, cottage cheese, swiss cheese, lac vaccinum, goat milk, calcarea carbonica, lac defloratum, sepia, sulphur liquid
BioActive Nutritional

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 Facts:

ACTIVE INGREDIENTS:

American Cheese 9X, 12X, 15X, 30X, Blue Cheese 9X, 12X, 15X, 30X, Brie Cheese 9X, 12X, 15X, 30X, Cheddar Cheese 9X, 12X, 15X, 30X, Cottage Cheese 9X, 12X, 15X, 30X, Swiss Cheese 9X, 12X, 15X, 30X, Lac Vaccinum 9X, 12X, 15X, 30X, Goat Milk 9X, 12X, 15X, 30X, Calcarea Carbonica 12X, Lac Defloratum 12X, Sepia 12X, Sulphur 12X.

INDICATIONS:

For temporary relief of allergies due to milk products.

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 allergies due to milk products.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

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

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

DAIRY ANTIGENS

HOMEOPATHIC

1 FL OZ (30 ml)

Dairy Antigens

DAIRY ANTIGENS
american cheese, blue cheese, brie cheese, cheddar cheese, cottage cheese, swiss cheese, lac vaccinum, goat milk, calcarea carbonica, lac defloratum, sepia, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0223
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6)	WHEY	9 [hp_X] in 1 mL
CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM PHOSPHATE, UNSPECIFIED FORM	9 [hp_X] in 1 mL
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	SODIUM CITRATE, UNSPECIFIED FORM	9 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	9 [hp_X] in 1 mL
SODIUM PHOSPHATE (UNII: SE337SVY37) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE	9 [hp_X] in 1 mL
SORBIC ACID (UNII: X045WJ989B) (SORBIC ACID - UNII:X045WJ989B)	SORBIC ACID	9 [hp_X] in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	9 [hp_X] in 1 mL
APOCAROTENAL (UNII: V22N3E2U32) (APOCAROTENAL - UNII:V22N3E2U32)	APOCAROTENAL	9 [hp_X] in 1 mL
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	9 [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	9 [hp_X] in 1 mL
CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED (UNII: G44KTI7KIS) (CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED - UNII:G44KTI7KIS)	CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED	9 [hp_X] in 1 mL
CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED (UNII: CJP9NL7JSJ) (CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED - UNII:CJP9NL7JSJ)	CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED	9 [hp_X] in 1 mL
CASEIN, LACTOCOCCUS LACTIS CULTURED (UNII: 489F5JNV5B) (CASEIN, LACTOCOCCUS LACTIS CULTURED - UNII:489F5JNV5B)	CASEIN, LACTOCOCCUS LACTIS CULTURED	9 [hp_X] in 1 mL
CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED (UNII: EV7Y02KOMA) (CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED - UNII:EV7Y02KOMA)	CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED	9 [hp_X] in 1 mL
CASEIN, EMMENTAL CULTURED (UNII: 13811K7P3X) (CASEIN, EMMENTAL CULTURED - UNII:13811K7P3X)	CASEIN, EMMENTAL CULTURED	9 [hp_X] in 1 mL
COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT)	COW MILK	9 [hp_X] in 1 mL
GOAT MILK (UNII: XE5K5I4RP7) (GOAT MILK - UNII:XE5K5I4RP7)	GOAT MILK	9 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X] in 1 mL
SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A)	SKIM MILK	12 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0223-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/20/2013	07/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/20/2013	07/31/2023

Labeler - BioActive Nutritional (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0223) , api manufacture(43857-0223) , label(43857-0223) , pack(43857-0223)

Revised: 11/2021

Document Id: 539aa6ba-f761-4b54-935c-0de8b8b8be6c

Set id: b580ae94-c480-4ee8-8b43-fc6f62e7cf27

Version: 4

Effective Time: 20211129

BioActive Nutritional