SPL v1
SPL
SPL Set ID 22de9aa2-83f1-4453-9d14-13af3e3aee9f
Route
ORAL
Published
Effective Date 2015-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (30 [hp_C]) .alpha.-lipoic Acid, (+/-)- (30 1) Agrimonia Eupatoria Flower Ammonia Ammonium Cation Arsenate Ion Antimony Cation (3+) Antimony Trisulfide Arabica Coffee Bean Arsenic Cation (3+) Asarum Europaeum Aspidosperma Quebracho-blanco Bark Atropa Belladonna Avena Sativa Flowering Top Bos Taurus Hypothalamus Bromine Calcium Cation Capsicum Carbon Disulfide Carbon Monoxide Chelidonium Majus Chlorine Chloroform Cinchona Officinalis Bark Coenzyme A Conium Maculatum Flowering Top Corticotropin Daphne Odora Bark Datura Stramonium Delphinium Staphisagria Seed Dieffenbachia Seguine Echinacea Purpurea Epinephrine Eschscholzia Californica Formaldehyde Glycyrrhiza Glabra Goldenseal Helianthus Annuus Flowering Top Herring Sperm Dna Hops Horse Chestnut Hypericum Perforatum Juglans Regia Flowering Top Juniperus Communis Whole Lead Liquid Petroleum Lobaria Pulmonaria Lobelia Inflata Lonicera Periclymenum Flowering Twig Lycopodium Clavatum Spore Matricaria Recutita Mercury Nicotine .alpha.-ketoglutaric Acid Passiflora Incarnata Flowering Top Phenol Phytolacca Americana Root Picea Mariana Resin Plantago Major Carbonate Ion Potassium Cation Dichromate Ion Iodide Ion Phosphate Ion Pulsatilla Pratensis Ricinus Communis Seed Scrophularia Nodosa Semecarpus Anacardium Juice Chloride Ion Solidago Virgaurea Flowering Top Strychnos Ignatii Seed Strychnos Nux-vomica Seed Sucrose Sulfur Iodide Sulfuric Acid Sus Scrofa Pituitary Gland Syzygium Jambos Seed Taraxacum Officinale Thuja Occidentalis Leafy Twig Tin Tobacco Leaf
Inactive Ingredients
Cadmium Sulfate Glycerin Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-09-10

Description

Equal amounts of each HPUS ingredient in 30C, 200C, 1M, LM1, LM2, LM3, LM4, & LM5 Potencies: Abies nigra, Aconitum napellus, Adrenalinum, Adrenocorticotrophin, Aesculus hippo flos, Agrimonia eupatoria flos, Alpha-katoglutaricum acidum, Alpha -lipoicum, acidum, Ammonium carbonicum, Ammonium arsenicicum, Antimonium crudum, Antimonium lartaricum, Arsenicum album, Arsenicum ioatum, Asarum europaeum, Avena sativa, Bel adonna, Bromium, Bryonia, Cadmium sulphuricum, Caladium seguinum, Calcarea iodata, Calcarea phosphorica, Capsicum annum, Carbolicum acidum, Carboneum oxygenisatum, Carboneum sulphuratum, Chamomilla, Chelidonium majus, chlorinum,Chloroformum, Cinchona officinalis, Coenzyme A. Colfea cruda, Conium maculatum, Daphne indica, DNA, Echinacea purpurea, Eschscholtzia californica, Eugenia jambosa, Formalinum, Glycyrrhiza glabra, Helianthus annus, Humulus lupulus, Hydrastis canadensis, Hypericum perforatum, Hypthalamus, Ignatia amara, juglans regia flos, Juniperus communis, Kali bichromicum, Kali Carbonicum, Kali iodatum, Kali muriaticum, Kali phophoricum, Lobelia inflata, Lonicera periclymenum, Lycopodium clavatum, Mercurius vivus, Natrum muriaticum, Nicotinum, Nux vornica, Passiflora incarnata, Petroleum, Phytolacca decandra, Pituitarum posterium, Plantago major, Plumbum metlicum, Pulsatilla, Quebracho, Ricinus cmmunis, Saccharum officinale, Scrophularia nodosa, Solidago virgaurea, Stannum metallicum, Staphysagria,Sticta pulmonaria, Stramonium, Sulphur iodatum, Sulphuricum acidum, Tabacum, Taraxacum officinale, Thuja occidentalis.

Indications and Usage

For temporary relief of general symptoms of tobacco cravings including: tobacco cravings (smoking or chew type tobaccos), headaches, shortness of breath, cough, nervousness, tightness in chest, irritability, restlessness, insomnia, craving for stimulants, nausa, toxic effects from ingested substances, anxiety, lightheadedness, dizziness and poor concentration.

Purpose

For temporary relief of general symptoms of tobacco cravings including: tobacco cravings (smoking or chew-type tobaccos), headaches, shortness of breath, cough, nervousness, tightness in chest, irritability, restlessness, insomnia, craving for stimulants, nausea, toxic effcts from ingested  substances, enxiety, lightheadedness, dizziness and poor concentration.


Medication Information

Indications and Usage

For temporary relief of general symptoms of tobacco cravings including: tobacco cravings (smoking or chew type tobaccos), headaches, shortness of breath, cough, nervousness, tightness in chest, irritability, restlessness, insomnia, craving for stimulants, nausa, toxic effects from ingested substances, anxiety, lightheadedness, dizziness and poor concentration.

Purpose

For temporary relief of general symptoms of tobacco cravings including: tobacco cravings (smoking or chew-type tobaccos), headaches, shortness of breath, cough, nervousness, tightness in chest, irritability, restlessness, insomnia, craving for stimulants, nausea, toxic effcts from ingested  substances, enxiety, lightheadedness, dizziness and poor concentration.

Description

Equal amounts of each HPUS ingredient in 30C, 200C, 1M, LM1, LM2, LM3, LM4, & LM5 Potencies: Abies nigra, Aconitum napellus, Adrenalinum, Adrenocorticotrophin, Aesculus hippo flos, Agrimonia eupatoria flos, Alpha-katoglutaricum acidum, Alpha -lipoicum, acidum, Ammonium carbonicum, Ammonium arsenicicum, Antimonium crudum, Antimonium lartaricum, Arsenicum album, Arsenicum ioatum, Asarum europaeum, Avena sativa, Bel adonna, Bromium, Bryonia, Cadmium sulphuricum, Caladium seguinum, Calcarea iodata, Calcarea phosphorica, Capsicum annum, Carbolicum acidum, Carboneum oxygenisatum, Carboneum sulphuratum, Chamomilla, Chelidonium majus, chlorinum,Chloroformum, Cinchona officinalis, Coenzyme A. Colfea cruda, Conium maculatum, Daphne indica, DNA, Echinacea purpurea, Eschscholtzia californica, Eugenia jambosa, Formalinum, Glycyrrhiza glabra, Helianthus annus, Humulus lupulus, Hydrastis canadensis, Hypericum perforatum, Hypthalamus, Ignatia amara, juglans regia flos, Juniperus communis, Kali bichromicum, Kali Carbonicum, Kali iodatum, Kali muriaticum, Kali phophoricum, Lobelia inflata, Lonicera periclymenum, Lycopodium clavatum, Mercurius vivus, Natrum muriaticum, Nicotinum, Nux vornica, Passiflora incarnata, Petroleum, Phytolacca decandra, Pituitarum posterium, Plantago major, Plumbum metlicum, Pulsatilla, Quebracho, Ricinus cmmunis, Saccharum officinale, Scrophularia nodosa, Solidago virgaurea, Stannum metallicum, Staphysagria,Sticta pulmonaria, Stramonium, Sulphur iodatum, Sulphuricum acidum, Tabacum, Taraxacum officinale, Thuja occidentalis.

Section 51945-4

Section 55106-9

Equal amounts of each HPUS ingredient in 30C, 200C, 1M, LM1, LM2, LM3, LM4, & LM5 Potencies:

Abies nigra, Aconitum napellus, Adrenalinum, Adrenocorticotrophin, Aesculus hippo flos, Agrimonia eupatoria flos, Alpha-katoglutaricum acidum, Alpha -lipoicum, acidum, Ammonium carbonicum, Ammonium arsenicicum, Antimonium crudum, Antimonium lartaricum, Arsenicum album, Arsenicum ioatum, Asarum europaeum, Avena sativa, Bel adonna, Bromium, Bryonia, Cadmium sulphuricum, Caladium seguinum, Calcarea iodata, Calcarea phosphorica, Capsicum annum, Carbolicum acidum, Carboneum oxygenisatum, Carboneum sulphuratum, Chamomilla, Chelidonium majus, chlorinum,Chloroformum, Cinchona officinalis, Coenzyme A. Colfea cruda, Conium maculatum, Daphne indica, DNA, Echinacea purpurea, Eschscholtzia californica, Eugenia jambosa, Formalinum, Glycyrrhiza glabra, Helianthus annus, Humulus lupulus, Hydrastis canadensis, Hypericum perforatum, Hypthalamus, Ignatia amara, juglans regia flos, Juniperus communis, Kali bichromicum, Kali Carbonicum, Kali iodatum, Kali muriaticum, Kali phophoricum, Lobelia inflata, Lonicera periclymenum, Lycopodium clavatum, Mercurius vivus, Natrum muriaticum, Nicotinum, Nux vornica, Passiflora incarnata, Petroleum, Phytolacca decandra, Pituitarum posterium, Plantago major, Plumbum metlicum, Pulsatilla, Quebracho, Ricinus cmmunis, Saccharum officinale, Scrophularia nodosa, Solidago virgaurea, Stannum metallicum, Staphysagria,Sticta pulmonaria, Stramonium, Sulphur iodatum, Sulphuricum acidum, Tabacum, Taraxacum officinale, Thuja occidentalis.

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask your doctor befgore use

  • if you are under a doctor's care for any serious condition
  • taking any other drug

Stop use and ask a doctor if symptoms persist, worsen, or if new symptoms occur.

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

Otc Purpose Section

For temporary relief of general symptoms of tobacco cravings including: tobacco cravings (smoking or chew-type tobaccos), headaches, shortness of breath, cough, nervousness, tightness in chest, irritability, restlessness, insomnia, craving for stimulants, nausea, toxic effcts from ingested  substances, enxiety, lightheadedness, dizziness and poor concentration.

Inactive Ingredient Section

Vegetable glycerin 10%, Purified Water.

Dosage & Administration Section

Fill bottle dropper by squeezing the rubber dropper-top firmly and then releasing.

Place full dropper of the liquid directly into mouth under the tongue.

Hold under tongue for 30 seconds then swallow. use approximately 1 full dropper, 1 to 3 times daily, or as needed for relief of symptoms.

A spray, fine mist or vapor can be created by placing 1 dropper into an atomizer and ten atomizing, 1 to 3 times per day, as needed for relief of symptoms.

Use 5 days per week.

Do not use more than directed.

Otc Keep Out of Reach of Children Section

Keep out of reach of children.


Structured Label Content

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Equal amounts of each HPUS ingredient in 30C, 200C, 1M, LM1, LM2, LM3, LM4, & LM5 Potencies:

Abies nigra, Aconitum napellus, Adrenalinum, Adrenocorticotrophin, Aesculus hippo flos, Agrimonia eupatoria flos, Alpha-katoglutaricum acidum, Alpha -lipoicum, acidum, Ammonium carbonicum, Ammonium arsenicicum, Antimonium crudum, Antimonium lartaricum, Arsenicum album, Arsenicum ioatum, Asarum europaeum, Avena sativa, Bel adonna, Bromium, Bryonia, Cadmium sulphuricum, Caladium seguinum, Calcarea iodata, Calcarea phosphorica, Capsicum annum, Carbolicum acidum, Carboneum oxygenisatum, Carboneum sulphuratum, Chamomilla, Chelidonium majus, chlorinum,Chloroformum, Cinchona officinalis, Coenzyme A. Colfea cruda, Conium maculatum, Daphne indica, DNA, Echinacea purpurea, Eschscholtzia californica, Eugenia jambosa, Formalinum, Glycyrrhiza glabra, Helianthus annus, Humulus lupulus, Hydrastis canadensis, Hypericum perforatum, Hypthalamus, Ignatia amara, juglans regia flos, Juniperus communis, Kali bichromicum, Kali Carbonicum, Kali iodatum, Kali muriaticum, Kali phophoricum, Lobelia inflata, Lonicera periclymenum, Lycopodium clavatum, Mercurius vivus, Natrum muriaticum, Nicotinum, Nux vornica, Passiflora incarnata, Petroleum, Phytolacca decandra, Pituitarum posterium, Plantago major, Plumbum metlicum, Pulsatilla, Quebracho, Ricinus cmmunis, Saccharum officinale, Scrophularia nodosa, Solidago virgaurea, Stannum metallicum, Staphysagria,Sticta pulmonaria, Stramonium, Sulphur iodatum, Sulphuricum acidum, Tabacum, Taraxacum officinale, Thuja occidentalis.

Warnings (WARNINGS)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask your doctor befgore use

  • if you are under a doctor's care for any serious condition
  • taking any other drug

Stop use and ask a doctor if symptoms persist, worsen, or if new symptoms occur.

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

Indications and Usage

For temporary relief of general symptoms of tobacco cravings including: tobacco cravings (smoking or chew type tobaccos), headaches, shortness of breath, cough, nervousness, tightness in chest, irritability, restlessness, insomnia, craving for stimulants, nausa, toxic effects from ingested substances, anxiety, lightheadedness, dizziness and poor concentration.

Otc Purpose Section (OTC - PURPOSE SECTION)

For temporary relief of general symptoms of tobacco cravings including: tobacco cravings (smoking or chew-type tobaccos), headaches, shortness of breath, cough, nervousness, tightness in chest, irritability, restlessness, insomnia, craving for stimulants, nausea, toxic effcts from ingested  substances, enxiety, lightheadedness, dizziness and poor concentration.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Vegetable glycerin 10%, Purified Water.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Fill bottle dropper by squeezing the rubber dropper-top firmly and then releasing.

Place full dropper of the liquid directly into mouth under the tongue.

Hold under tongue for 30 seconds then swallow. use approximately 1 full dropper, 1 to 3 times daily, or as needed for relief of symptoms.

A spray, fine mist or vapor can be created by placing 1 dropper into an atomizer and ten atomizing, 1 to 3 times per day, as needed for relief of symptoms.

Use 5 days per week.

Do not use more than directed.

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


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