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Pts/stress remedy - Prescription Drug Labeling

Product NDC Code 43742-1322
Drug Name

Pts/stress remedy

Type Brand
Pharm Class Allergens [CS],
Cell-mediated Immunity [PE],
Dietary Proteins [CS],
Increased Histamine Release [PE],
Mood Stabilizer [EPC],
Non-Standardized Food Allergenic Extract [EPC],
Plant Proteins [CS]
Active Ingredients
Aconitum napellus 8 [hp_x]/ml
Ambergris 6 [hp_x]/ml
Androctonus australis venom 6 [hp_c]/ml
Argemone mexicana 12 [hp_x]/ml
Arnica montana 6 [hp_x]/ml
Arsenic trioxide 12 [hp_x]/ml
Cicuta virosa root 12 [hp_x]/ml
Cocoa 6 [hp_x]/ml
Datura stramonium 12 [hp_x]/ml
Dibasic potassium phosphate 3 [hp_x]/ml
Hyoscyamus niger 12 [hp_x]/ml
Lilium lancifolium whole flowering 12 [hp_x]/ml
Lithium carbonate 8 [hp_x]/ml
Lycosa tarantula 12 [hp_x]/ml
Oyster shell calcium carbonate, crude 8 [hp_x]/ml
Phosphoric acid 6 [hp_x]/ml
Sodium chloride 12 [hp_x]/ml
Strychnos ignatii seed 12 [hp_x]/ml
Sus scrofa adrenal gland 8 [hp_x]/ml
Sus scrofa cerebrum 8 [hp_x]/ml
Route ORAL
Dosage Form LIQUID
Labeler Name Deseret Biologicals, Inc.
Packages
Package NDC Code Description
43742-1322-1 30 ml in 1 bottle, dropper (43742-1322-1)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
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.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: Demineralized Water, 25% Ethanol.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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.

Purpose

Information about the drug product’s indications for use.
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.

Spl product data elements

Usually a list of ingredients in a drug product.
PTS/Stress Remedy Kali Phosphoricum, Ambra Grisea, Cacao, Phosphoricum Acidum, Arnica Montana, Calcarea Carbonica, Cerebrum Suis, Glandula Suprarenalis Suis, Lithium Carbonicum, Aconitum Napellus, Argemone Mexicana, Arsenicum Album, Cicuta Virosa, Hyoscyamus Niger, Ignatia Tigrinum, Natrum Muriaticum, Tarentula Hispanica, Stramonium, Buthus Australis DIBASIC POTASSIUM PHOSPHATE PHOSPHATE ION AMBERGRIS AMBERGRIS COCOA COCOA PHOSPHORIC ACID PHOSPHORIC ACID ARNICA MONTANA ARNICA MONTANA OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE SUS SCROFA CEREBRUM SUS SCROFA CEREBRUM SUS SCROFA ADRENAL GLAND SUS SCROFA ADRENAL GLAND LITHIUM CARBONATE LITHIUM CATION ACONITUM NAPELLUS ACONITUM NAPELLUS ARGEMONE MEXICANA ARGEMONE MEXICANA ARSENIC TRIOXIDE ARSENIC CATION (3+) CICUTA VIROSA ROOT CICUTA VIROSA ROOT HYOSCYAMUS NIGER HYOSCYAMUS NIGER STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED LILIUM LANCIFOLIUM WHOLE FLOWERING LILIUM LANCIFOLIUM WHOLE FLOWERING SODIUM CHLORIDE CHLORIDE ION LYCOSA TARANTULA LYCOSA TARANTULA DATURA STRAMONIUM DATURA STRAMONIUM ANDROCTONUS AUSTRALIS VENOM ANDROCTONUS AUSTRALIS VENOM WATER ALCOHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL DISPLAY: DES BIO NDC 43742-1322-1 HOMEOPATHIC PTS/STRESS REMEDY 1 FL OZ (30 ml) PTS/Stress Remedy

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
QUESTIONS: Dist. By: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070 www.desbio.com

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API