Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID f03d8463-0a6d-4577-8fba-9cba246d3d45
Route
ORAL
Published
Effective Date 2024-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chaste Tree (6 [hp_X]) Sulfide Ion (12 [hp_X]) Candida Albicans (15 [hp_X]) Black Cohosh (10 [hp_X]) Anamirta Cocculus Seed (8 [hp_X]) Conium Maculatum Flowering Top (9 [hp_X]) Cyclamen Purpurascens Tuber Micrurus Corallinus Venom Estrone Sus Scrofa Hypothalamus Carbonate Ion Canis Lupus Familiaris Milk Lachesis Muta Venom Lycopodium Clavatum Spore Pulsatilla Pratensis Whole Sucrose Tin Thuja Occidentalis Leafy Twig Thyroid, Bovine
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-09-23

Description

Agnus Castus 6X, Aurum Sulphuratum 12X, Candida Albicans 12X, 30X, Cimicifuga Racemosa 6X, Cocculus Indicus 12X, Conium Maculatum 12X, Cyclamen Europaeum 12X, Elaps Corallinus 15X, Folliculinum 10X, 12X, 30X, Hypothalamus Suis 8X, Kali Carbonicum 6X, Lac Caninum 12X, Lachesis Mutus 12X, Lycopodium Clavatum 6X, Magnesia Carbonica 12X, Pulsatilla (Pratensis) 12X, Saccharum Officinale 6X, Stannum Metallicum 12X, Thuja Occidentalis 9X, Thyroidinum (Bovine) 6X, 12X, 30X.

Purpose

Agnus Castus – Symptoms of PMS, Aurum Sulphuratum - Irritability, Candida Albicans - Anger, Cimicifuga Racemosa - Sadness, Cocculus Indicus - Weeping, Conium Maculatum - Anxiety, Cyclamen Europaeum - Acne, Elaps Corallinus – Bowel Congestion, Folliculinum – Head Pain, Hypothalamus Suis – Muscle Pain Before Menses, Kali Carbonicum – Symptoms of PMS, Lac Caninum – Mood Swings, Lachesis Mutus - Irritability, Lycopodium Clavatum - Anger, Magnesia Carbonica - Sadness, Pulsatilla (Pratensis) - Weeping, Saccharum Officinale - Anxiety, Stannum Metallicum – Head Pain, Thuja Occidentalis – Mood Swings, Thyroidinum (Bovine) – Bowel Congestion


Medication Information

Purpose

Agnus Castus – Symptoms of PMS, Aurum Sulphuratum - Irritability, Candida Albicans - Anger, Cimicifuga Racemosa - Sadness, Cocculus Indicus - Weeping, Conium Maculatum - Anxiety, Cyclamen Europaeum - Acne, Elaps Corallinus – Bowel Congestion, Folliculinum – Head Pain, Hypothalamus Suis – Muscle Pain Before Menses, Kali Carbonicum – Symptoms of PMS, Lac Caninum – Mood Swings, Lachesis Mutus - Irritability, Lycopodium Clavatum - Anger, Magnesia Carbonica - Sadness, Pulsatilla (Pratensis) - Weeping, Saccharum Officinale - Anxiety, Stannum Metallicum – Head Pain, Thuja Occidentalis – Mood Swings, Thyroidinum (Bovine) – Bowel Congestion

Description

Agnus Castus 6X, Aurum Sulphuratum 12X, Candida Albicans 12X, 30X, Cimicifuga Racemosa 6X, Cocculus Indicus 12X, Conium Maculatum 12X, Cyclamen Europaeum 12X, Elaps Corallinus 15X, Folliculinum 10X, 12X, 30X, Hypothalamus Suis 8X, Kali Carbonicum 6X, Lac Caninum 12X, Lachesis Mutus 12X, Lycopodium Clavatum 6X, Magnesia Carbonica 12X, Pulsatilla (Pratensis) 12X, Saccharum Officinale 6X, Stannum Metallicum 12X, Thuja Occidentalis 9X, Thyroidinum (Bovine) 6X, 12X, 30X.

Uses:

• For the temporary relief of symptoms including:

• symptoms of PMS • mood swings  • irritability • anger • sadness  • weeping

• anxiety • acne • bowel congestion • head pain • muscle pain before menses

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Purpose:

Agnus Castus – Symptoms of PMS, Aurum Sulphuratum - Irritability, Candida Albicans - Anger, Cimicifuga Racemosa - Sadness, Cocculus Indicus - Weeping, Conium Maculatum - Anxiety, Cyclamen Europaeum - Acne, Elaps Corallinus – Bowel Congestion, Folliculinum – Head Pain, Hypothalamus Suis – Muscle Pain Before Menses, Kali Carbonicum – Symptoms of PMS, Lac Caninum – Mood Swings, Lachesis Mutus - Irritability, Lycopodium Clavatum - Anger, Magnesia Carbonica - Sadness, Pulsatilla (Pratensis) - Weeping, Saccharum Officinale - Anxiety, Stannum Metallicum – Head Pain, Thuja Occidentalis – Mood Swings, Thyroidinum (Bovine) – Bowel Congestion

Warnings:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

Questions:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

800-827-8204

Directions:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients:

Agnus Castus 6X, Aurum Sulphuratum 12X, Candida Albicans 12X, 30X, Cimicifuga Racemosa 6X, Cocculus Indicus 12X, Conium Maculatum 12X, Cyclamen Europaeum 12X, Elaps Corallinus 15X, Folliculinum 10X, 12X, 30X, Hypothalamus Suis 8X, Kali Carbonicum 6X, Lac Caninum 12X, Lachesis Mutus 12X, Lycopodium Clavatum 6X, Magnesia Carbonica 12X, Pulsatilla (Pratensis) 12X, Saccharum Officinale 6X, Stannum Metallicum 12X, Thuja Occidentalis 9X, Thyroidinum (Bovine) 6X, 12X, 30X.

Inactive Ingredients:

Demineralized water, 25% ethanol

Package Label Display:

DesBio

PMS Relief

Homeopathic

NDC 43742-2199-1

1 FL OZ (30 ml)

Keep Out of Reach of Children:

In case of overdose, contact a physician or Poison Control Center right away.


Structured Label Content

Uses: (USES:)

• For the temporary relief of symptoms including:

• symptoms of PMS • mood swings  • irritability • anger • sadness  • weeping

• anxiety • acne • bowel congestion • head pain • muscle pain before menses

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Purpose: (PURPOSE:)

Agnus Castus – Symptoms of PMS, Aurum Sulphuratum - Irritability, Candida Albicans - Anger, Cimicifuga Racemosa - Sadness, Cocculus Indicus - Weeping, Conium Maculatum - Anxiety, Cyclamen Europaeum - Acne, Elaps Corallinus – Bowel Congestion, Folliculinum – Head Pain, Hypothalamus Suis – Muscle Pain Before Menses, Kali Carbonicum – Symptoms of PMS, Lac Caninum – Mood Swings, Lachesis Mutus - Irritability, Lycopodium Clavatum - Anger, Magnesia Carbonica - Sadness, Pulsatilla (Pratensis) - Weeping, Saccharum Officinale - Anxiety, Stannum Metallicum – Head Pain, Thuja Occidentalis – Mood Swings, Thyroidinum (Bovine) – Bowel Congestion

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

Questions: (QUESTIONS:)

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

800-827-8204

Directions: (DIRECTIONS:)

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Agnus Castus 6X, Aurum Sulphuratum 12X, Candida Albicans 12X, 30X, Cimicifuga Racemosa 6X, Cocculus Indicus 12X, Conium Maculatum 12X, Cyclamen Europaeum 12X, Elaps Corallinus 15X, Folliculinum 10X, 12X, 30X, Hypothalamus Suis 8X, Kali Carbonicum 6X, Lac Caninum 12X, Lachesis Mutus 12X, Lycopodium Clavatum 6X, Magnesia Carbonica 12X, Pulsatilla (Pratensis) 12X, Saccharum Officinale 6X, Stannum Metallicum 12X, Thuja Occidentalis 9X, Thyroidinum (Bovine) 6X, 12X, 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 25% ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

DesBio

PMS Relief

Homeopathic

NDC 43742-2199-1

1 FL OZ (30 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, contact a physician or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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