Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID ef3f66f9-47bc-4fce-8950-ed2319bc30d6
Route
ORAL
Published
Effective Date 2022-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Galium Aparine (3 [hp_X]) Chaste Tree (6 [hp_X]) Apis Mellifera (12 [hp_X]) Capsicum (30 [hp_C]) Chelidonium Majus (200 [hp_C]) Taraxacum Officinale Urtica Dioica Zanthoxylum Americanum Bark Fucus Vesiculosus Phosphate Ion Magnesium Cation Sarsaparilla Ubidecarenone Oyster Shell Calcium Carbonate, Crude Graphite Lycopodium Clavatum Spore Semecarpus Anacardium Juice Colchicum Autumnale Bulb Strychnos Nux-vomica Seed Phytolacca Americana Root Pulsatilla Pratensis Whole Histamine
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2022-01-21 Until 2027-02-04

Description

Galium Aparine 3X, Agnus Castus 6X, Apis Mellifica 6X, Capsicum Annuum 6X, Chelidonium Majus 6X, Taraxacum Officinale 6X, Urtica Dioica 6X, Xanthoxylum Fraxineum 6X, Fucus Vesiculosus 6X, 12X, 30X, Kali Phosphoricum 12X, Magnesia Phosphorica 12X, Natrum Phosphoricum12X, Sarsaparilla (Smilax Regelii) 12X, Ubidecarenonum 12X, Calcarea Carbonica 12X, 30X, 60X, Graphites 12X, 30X, 60X, Lycopodium Clavatum 12X, 30X, 60X, Anacardium Orientale 30C, Colchicum Autumnale 30C, Nux Vomica 30C, Phytolacca Decandra 30C, Pulsatilla (Pratensis) 30C, Histaminum Hydrochloricum 200C.


Medication Information

Description

Galium Aparine 3X, Agnus Castus 6X, Apis Mellifica 6X, Capsicum Annuum 6X, Chelidonium Majus 6X, Taraxacum Officinale 6X, Urtica Dioica 6X, Xanthoxylum Fraxineum 6X, Fucus Vesiculosus 6X, 12X, 30X, Kali Phosphoricum 12X, Magnesia Phosphorica 12X, Natrum Phosphoricum12X, Sarsaparilla (Smilax Regelii) 12X, Ubidecarenonum 12X, Calcarea Carbonica 12X, 30X, 60X, Graphites 12X, 30X, 60X, Lycopodium Clavatum 12X, 30X, 60X, Anacardium Orientale 30C, Colchicum Autumnale 30C, Nux Vomica 30C, Phytolacca Decandra 30C, Pulsatilla (Pratensis) 30C, Histaminum Hydrochloricum 200C.

Warnings:

Keep out of reach of children. In case of overdose, get medical help or contact a 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:

Distributed by Heilen

Brentwood, MO 63144

888-305-1412 • www.goheilen.com

Directions:

1-12 drops under the tongue, 3 times a day or as directed by your health professional. Avoid eating and/or drinking 15 minutes or longer before or after taking. Consult a physician for use in children under 12 years of age. Do not touch dropper to lips, teeth, or tongue to avoid contamination. Keep lid tightly closed when not in use.

Active Ingredients:

Galium Aparine 3X, Agnus Castus 6X, Apis Mellifica 6X, Capsicum Annuum 6X, Chelidonium Majus 6X, Taraxacum Officinale 6X, Urtica Dioica 6X, Xanthoxylum Fraxineum 6X, Fucus Vesiculosus 6X, 12X, 30X, Kali Phosphoricum 12X, Magnesia Phosphorica 12X, Natrum Phosphoricum12X, Sarsaparilla (Smilax Regelii) 12X, Ubidecarenonum 12X, Calcarea Carbonica 12X, 30X, 60X, Graphites 12X, 30X, 60X, Lycopodium Clavatum 12X, 30X, 60X, Anacardium Orientale 30C, Colchicum Autumnale 30C, Nux Vomica 30C, Phytolacca Decandra 30C, Pulsatilla (Pratensis) 30C, Histaminum Hydrochloricum 200C.

Inactive Ingredients:

demineralized water, 20% ethanol

Package Label Display:

        +plus

Heilen 

HOMEOPATHIC FORMULA

1 FL OZ (30 ml)

Homeopathic Indications:

For temporary relief of symptoms related to increased appetite, regulation of fat metabolism, sluggish metabolism, headache, and fatigue.**

**These statements are based upon homeopathic principles. They have not been approved 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:)

Keep out of reach of children. In case of overdose, get medical help or contact a 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:)

Distributed by Heilen

Brentwood, MO 63144

888-305-1412 • www.goheilen.com

Directions: (DIRECTIONS:)

1-12 drops under the tongue, 3 times a day or as directed by your health professional. Avoid eating and/or drinking 15 minutes or longer before or after taking. Consult a physician for use in children under 12 years of age. Do not touch dropper to lips, teeth, or tongue to avoid contamination. Keep lid tightly closed when not in use.

Active Ingredients: (ACTIVE INGREDIENTS:)

Galium Aparine 3X, Agnus Castus 6X, Apis Mellifica 6X, Capsicum Annuum 6X, Chelidonium Majus 6X, Taraxacum Officinale 6X, Urtica Dioica 6X, Xanthoxylum Fraxineum 6X, Fucus Vesiculosus 6X, 12X, 30X, Kali Phosphoricum 12X, Magnesia Phosphorica 12X, Natrum Phosphoricum12X, Sarsaparilla (Smilax Regelii) 12X, Ubidecarenonum 12X, Calcarea Carbonica 12X, 30X, 60X, Graphites 12X, 30X, 60X, Lycopodium Clavatum 12X, 30X, 60X, Anacardium Orientale 30C, Colchicum Autumnale 30C, Nux Vomica 30C, Phytolacca Decandra 30C, Pulsatilla (Pratensis) 30C, Histaminum Hydrochloricum 200C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

demineralized water, 20% ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

        +plus

Heilen 

HOMEOPATHIC FORMULA

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

For temporary relief of symptoms related to increased appetite, regulation of fat metabolism, sluggish metabolism, headache, and fatigue.**

**These statements are based upon homeopathic principles. They have not been approved 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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