Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 950cab64-990d-4639-8576-e7e88b200349
Route
ORAL
Published
Effective Date 2020-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oyster Shell Calcium Carbonate, Crude (12 [hp_X]) Skim Milk Sepia Officinalis Juice Sulfur Whey Casein, Lactococcus Lactis Cultured, Penicillium Roqueforti Cultured, Aged Casein, Lactococcus Lactis Cultured, Penicillium Camemberti Cultured, Aged Casein, Lactococcus Lactis Cultured, Aged Casein, Lactococcus Lactis Cultured Goat Milk Cow Milk Casein, Emmental Cultured
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2020-04-09 Until 2029-08-28

Description

Calcarea Carbonica 12X, Lac Defloratum 12X, Sepia 12X, Sulphur 12X, American Cheese 12X, 15X, 18x, 33X, Cheese (Stilton) 12X, 15X, 18x, 33X, Cheese (Camembert) 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Caprinum 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X.


Medication Information

Description

Calcarea Carbonica 12X, Lac Defloratum 12X, Sepia 12X, Sulphur 12X, American Cheese 12X, 15X, 18x, 33X, Cheese (Stilton) 12X, 15X, 18x, 33X, Cheese (Camembert) 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Caprinum 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X.

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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

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.

Active Ingredients:

Calcarea Carbonica 12X, Lac Defloratum 12X, Sepia 12X, Sulphur 12X, American Cheese 12X, 15X, 18x, 33X, Cheese (Stilton) 12X, 15X, 18x, 33X, Cheese (Camembert) 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Caprinum 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

DAIRY ANTIGENS

HOMEOPATHIC

1 FL OZ (30 ml)

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.


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

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

Indications: (INDICATIONS:)

For temporary relief of allergies due to milk products.

Active Ingredients: (ACTIVE INGREDIENTS:)

Calcarea Carbonica 12X, Lac Defloratum 12X, Sepia 12X, Sulphur 12X, American Cheese 12X, 15X, 18x, 33X, Cheese (Stilton) 12X, 15X, 18x, 33X, Cheese (Camembert) 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Caprinum 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

DAIRY ANTIGENS

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children: (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.


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