Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 05341147-789a-4844-9412-6a3044e5eb18
Route
ORAL
Published
Effective Date 2018-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphate Ion (3 [hp_X]) Ambergris (6 [hp_X]) Cocoa (8 [hp_X]) Phosphoric Acid (12 [hp_X]) Arnica Montana (6 [hp_C]) Oyster Shell Calcium Carbonate, Crude Sus Scrofa Cerebrum Sus Scrofa Adrenal Gland Lithium Cation Aconitum Napellus Argemone Mexicana Arsenic Cation (3+) Cicuta Virosa Root Hyoscyamus Niger Strychnos Ignatii Seed Lilium Lancifolium Whole Flowering Chloride Ion Lycosa Tarantula Datura Stramonium Androctonus Australis Venom
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-08-28 Until 2028-12-28

Description

Kali Phosphoricum 3X, Ambra Grisea 6X, Cacao 6X, Phosphoricum Acidum 6X, Arnica Montana 6X, 12X, 30X, Calcarea Carbonica 8X, Cerebrum Suis 8X, Glandula Suprarenalis Suis 8X, Lithium Carbonicum 8X, Aconitum Napellus 8X, 30X, Argemone Mexicana 12X, Arsenicum Album 12X, Cicuta Virosa 12X, Hyoscyamus Niger 12X, Ignatia Tigrinum 12X, Natrum Muriaticum 12X, Tarentula Hispanica 12X, Stramonium 12X, 30X, 60X, Buthus Australis 6C.


Medication Information

Description

Kali Phosphoricum 3X, Ambra Grisea 6X, Cacao 6X, Phosphoricum Acidum 6X, Arnica Montana 6X, 12X, 30X, Calcarea Carbonica 8X, Cerebrum Suis 8X, Glandula Suprarenalis Suis 8X, Lithium Carbonicum 8X, Aconitum Napellus 8X, 30X, Argemone Mexicana 12X, Arsenicum Album 12X, Cicuta Virosa 12X, Hyoscyamus Niger 12X, Ignatia Tigrinum 12X, Natrum Muriaticum 12X, Tarentula Hispanica 12X, Stramonium 12X, 30X, 60X, Buthus Australis 6C.

Warnings:

If pregnant or breastfeeding, 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: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

Directions:

1-10 drops under the tongue, 2 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients:

Kali Phosphoricum 3X, Ambra Grisea 6X, Cacao 6X, Phosphoricum Acidum 6X, Arnica Montana 6X, 12X, 30X, Calcarea Carbonica 8X, Cerebrum Suis 8X, Glandula Suprarenalis Suis 8X, Lithium Carbonicum 8X, Aconitum Napellus 8X, 30X, Argemone Mexicana 12X, Arsenicum Album 12X, Cicuta Virosa 12X, Hyoscyamus Niger 12X, Ignatia Tigrinum 12X, Natrum Muriaticum 12X, Tarentula Hispanica 12X, Stramonium 12X, 30X, 60X, Buthus Australis 6C.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

DESBIO

NDC 43742-1322-1

HOMEOPATHIC

PTS/STRESS

REMEDY

1 FL OZ (30 ml)

Homeopathic Indications:

For the temporary relief of symptoms of stress such as terror, horror, post traumatic stress, fight or flight response, recurring nightmares, difficulty sleeping, difficulty concentrating, restlessness, and easy irritability.**

**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, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings: (WARNINGS:)

If pregnant or breastfeeding, 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: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

Directions: (DIRECTIONS:)

1-10 drops under the tongue, 2 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:)

Kali Phosphoricum 3X, Ambra Grisea 6X, Cacao 6X, Phosphoricum Acidum 6X, Arnica Montana 6X, 12X, 30X, Calcarea Carbonica 8X, Cerebrum Suis 8X, Glandula Suprarenalis Suis 8X, Lithium Carbonicum 8X, Aconitum Napellus 8X, 30X, Argemone Mexicana 12X, Arsenicum Album 12X, Cicuta Virosa 12X, Hyoscyamus Niger 12X, Ignatia Tigrinum 12X, Natrum Muriaticum 12X, Tarentula Hispanica 12X, Stramonium 12X, 30X, 60X, Buthus Australis 6C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

DESBIO

NDC 43742-1322-1

HOMEOPATHIC

PTS/STRESS

REMEDY

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

For the temporary relief of symptoms of stress such as terror, horror, post traumatic stress, fight or flight response, recurring nightmares, difficulty sleeping, difficulty concentrating, restlessness, and easy irritability.**

**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, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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