Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 08e9d17b-9212-4822-9264-a15aa3a9c032
Route
ORAL
Published
Effective Date 2024-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Chamomilla (3 [hp_X]) Black Cohosh (4 [hp_X]) Chamaelirium Luteum Root (6 [hp_X]) Mentha Piperita (8 [hp_X]) Senna Leaf (12 [hp_X]) Valerian (15 [hp_X]) Viola Odorata Chaste Tree Ledum Palustre Twig Lilium Lancifolium Whole Flowering Delphinium Staphisagria Seed Saffron Goldenseal Cinchona Officinalis Bark Convallaria Majalis Cyclamen Purpurascens Tuber Cinnamon Hexaplex Trunculus Hypobranchial Gland Juice Naja Naja Venom
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-02-03

Description

Agnus Castus 4X, Chamomilla 3X, Cimicifuga Racemosa 3X, Cinchona Officinalis 8X, Cinnamomum 12X, Convallaria Majalis 8X, Crocus Sativus 6X, Cyclamen Europaeum 8X, Helonias Dioica 3X, Hydrastis Canadensis 6X, Ledum Palustre 4X, Lilium Tigrinum 4X, Mentha Piperita 3X, Murex Purpurea 12X, Naja Tripudians 15X, Senna (Cassia Angustifolia) 3X, Staphysagria 4X, Valeriana Officinalis 3X, Viola Odorata 3X.

Purpose

Agnus Castus – Female Support, Chamomilla – Fluid Retention, Cimicifuga Racemosa – Hot Flashes, Cinchona Officinalis – Painful Menses, Cinnamomum – Irregular Menses, Convallaria Majalis – Irregular Menses, Crocus Sativus – Mood Swings, Cyclamen Europaeum – Female Support, Helonias Dioica – Fluid Retention, Hydrastis Canadensis – Hot Flashes, Ledum Palustre – Painful Menses, Lilium Tigrinum – Irregular Menses, Mentha Piperita – Painful Menses, Murex Purpurea – Painful Menses, Naja Tripudians – Female Support, Senna (Cassia Angustifolia) – Fluid Retention, Staphysagria – Hot Flashes, Valeriana Officinalis – Painful Menses, Viola Odorata – Irregular Menses


Medication Information

Purpose

Agnus Castus – Female Support, Chamomilla – Fluid Retention, Cimicifuga Racemosa – Hot Flashes, Cinchona Officinalis – Painful Menses, Cinnamomum – Irregular Menses, Convallaria Majalis – Irregular Menses, Crocus Sativus – Mood Swings, Cyclamen Europaeum – Female Support, Helonias Dioica – Fluid Retention, Hydrastis Canadensis – Hot Flashes, Ledum Palustre – Painful Menses, Lilium Tigrinum – Irregular Menses, Mentha Piperita – Painful Menses, Murex Purpurea – Painful Menses, Naja Tripudians – Female Support, Senna (Cassia Angustifolia) – Fluid Retention, Staphysagria – Hot Flashes, Valeriana Officinalis – Painful Menses, Viola Odorata – Irregular Menses

Description

Agnus Castus 4X, Chamomilla 3X, Cimicifuga Racemosa 3X, Cinchona Officinalis 8X, Cinnamomum 12X, Convallaria Majalis 8X, Crocus Sativus 6X, Cyclamen Europaeum 8X, Helonias Dioica 3X, Hydrastis Canadensis 6X, Ledum Palustre 4X, Lilium Tigrinum 4X, Mentha Piperita 3X, Murex Purpurea 12X, Naja Tripudians 15X, Senna (Cassia Angustifolia) 3X, Staphysagria 4X, Valeriana Officinalis 3X, Viola Odorata 3X.

Uses:

• For the temporary relief of symptoms including:

• female support • fluid retention • hot flashes

• painful menses • irregular menses • mood swings

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

Purpose:

Agnus Castus – Female Support, Chamomilla – Fluid Retention, Cimicifuga Racemosa – Hot Flashes, Cinchona Officinalis – Painful Menses, Cinnamomum – Irregular Menses, Convallaria Majalis – Irregular Menses, Crocus Sativus – Mood Swings, Cyclamen Europaeum – Female Support, Helonias Dioica – Fluid Retention, Hydrastis Canadensis – Hot Flashes, Ledum Palustre – Painful Menses, Lilium Tigrinum – Irregular Menses, Mentha Piperita – Painful Menses, Murex Purpurea – Painful Menses, Naja Tripudians – Female Support, Senna (Cassia Angustifolia) – Fluid Retention, Staphysagria – Hot Flashes, Valeriana Officinalis – Painful Menses, Viola Odorata – Irregular Menses

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 4X, Chamomilla 3X, Cimicifuga Racemosa 3X, Cinchona Officinalis 8X, Cinnamomum 12X, Convallaria Majalis 8X, Crocus Sativus 6X, Cyclamen Europaeum 8X, Helonias Dioica 3X, Hydrastis Canadensis 6X, Ledum Palustre 4X, Lilium Tigrinum 4X, Mentha Piperita 3X, Murex Purpurea 12X, Naja Tripudians 15X, Senna (Cassia Angustifolia) 3X, Staphysagria 4X, Valeriana Officinalis 3X, Viola Odorata 3X.

Inactive Ingredients:

Demineralized water, 25% ethanol

Package Label Display:

Des Bio

Female Support

Homeopathic

NDC 43742-2077-1

1 FL OZ (30ml)

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:

• female support • fluid retention • hot flashes

• painful menses • irregular menses • mood swings

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

Purpose: (PURPOSE:)

Agnus Castus – Female Support, Chamomilla – Fluid Retention, Cimicifuga Racemosa – Hot Flashes, Cinchona Officinalis – Painful Menses, Cinnamomum – Irregular Menses, Convallaria Majalis – Irregular Menses, Crocus Sativus – Mood Swings, Cyclamen Europaeum – Female Support, Helonias Dioica – Fluid Retention, Hydrastis Canadensis – Hot Flashes, Ledum Palustre – Painful Menses, Lilium Tigrinum – Irregular Menses, Mentha Piperita – Painful Menses, Murex Purpurea – Painful Menses, Naja Tripudians – Female Support, Senna (Cassia Angustifolia) – Fluid Retention, Staphysagria – Hot Flashes, Valeriana Officinalis – Painful Menses, Viola Odorata – Irregular Menses

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 4X, Chamomilla 3X, Cimicifuga Racemosa 3X, Cinchona Officinalis 8X, Cinnamomum 12X, Convallaria Majalis 8X, Crocus Sativus 6X, Cyclamen Europaeum 8X, Helonias Dioica 3X, Hydrastis Canadensis 6X, Ledum Palustre 4X, Lilium Tigrinum 4X, Mentha Piperita 3X, Murex Purpurea 12X, Naja Tripudians 15X, Senna (Cassia Angustifolia) 3X, Staphysagria 4X, Valeriana Officinalis 3X, Viola Odorata 3X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 25% ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

Des Bio

Female Support

Homeopathic

NDC 43742-2077-1

1 FL OZ (30ml)

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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