Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 64a84841-ef9f-4b89-b7ad-60bb513c274d
Route
ORAL
Published
Effective Date 2023-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oyster Shell Calcium Carbonate, Crude (12 [hp_X]) Sepia Officinalis Juice (15 [hp_X]) 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 Active Since 2023-12-20

Description

(in each drop): 2.86% of Calcarea Carbonica 12X, 15X, Sepia 12X, 15X, Sulphur 12X, 15X; American Cheese 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X; Blue Cheese 15X, 18X, 33X, Camembert 15X, 18X, 33X, Lac Caprinum 15X, 18X, 33X.

Purpose

May temporarily relieve symptoms associated with dairy sensitivities.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

May temporarily relieve symptoms associated with dairy sensitivities.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop): 2.86% of Calcarea Carbonica 12X, 15X, Sepia 12X, 15X, Sulphur 12X, 15X; American Cheese 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X; Blue Cheese 15X, 18X, 33X, Camembert 15X, 18X, 33X, Lac Caprinum 15X, 18X, 33X.

Purpose:

May temporarily relieve symptoms associated with dairy sensitivities.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

If pregnant or breast-feeding, ask a health 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:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve symptoms associated with dairy sensitivities.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

(in each drop): 2.86% of Calcarea Carbonica 12X, 15X, Sepia 12X, 15X, Sulphur 12X, 15X; American Cheese 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X; Blue Cheese 15X, 18X, 33X, Camembert 15X, 18X, 33X, Lac Caprinum 15X, 18X, 33X.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:
ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DAIRY

ANTIGENS

1 fl. oz. (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (PURPOSE:)

May temporarily relieve symptoms associated with dairy sensitivities.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health 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:)

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

Directions: (DIRECTIONS:)

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve symptoms associated with dairy sensitivities.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): 2.86% of Calcarea Carbonica 12X, 15X, Sepia 12X, 15X, Sulphur 12X, 15X; American Cheese 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X; Blue Cheese 15X, 18X, 33X, Camembert 15X, 18X, 33X, Lac Caprinum 15X, 18X, 33X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)
ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DAIRY

ANTIGENS

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.


Advanced Ingredient Data


Raw Label Data

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