Drug Facts:

Drug Facts:
SPL v9
SPL
SPL Set ID ca073beb-330d-406c-9bf5-196a89f3ab58
Route
ORAL
Published
Effective Date 2024-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-07-10 Until 2028-12-08

Description

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


Medication Information

Description

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

Warnings:

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

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

Tamper seal: "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

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

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

DESBIO

NDC 43742-1342-1

HOMEOPATHIC

PMS

RELIEF

1 FL OZ (30 ml)

Homeopathic Indications:

For the temporary relief of symptoms related to premenstrual syndrome, such as 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.

Keep Out of Reach of Children:

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


Structured Label Content

Warnings: (WARNINGS:)

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

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

Tamper seal: "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

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

DESBIO

NDC 43742-1342-1

HOMEOPATHIC

PMS

RELIEF

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

For the temporary relief of symptoms related to premenstrual syndrome, such as 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.

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

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


Advanced Ingredient Data


Raw Label Data

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