Menopause

Menopause
SPL v2
SPL
SPL Set ID 9f04d505-7475-ef8a-57ab-eb820fb49726
Route
ORAL
Published
Effective Date 2012-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Micrurus Corallinus Venom (30 [hp_X]) Chaste Tree (10 [hp_X]) Angelica Sinensis Root (3 [hp_X]) Arsenic Cation (3+) Bryonia Alba Root Lytta Vesicatoria Caulophyllum Thalictroides Root Black Cohosh Cinchona Officinalis Bark Crotalus Horridus Horridus Venom Turnera Diffusa Leafy Twig Nitroglycerin Chamaelirium Luteum Root Strychnos Ignatii Seed Carbonate Ion Lachesis Muta Venom Naja Naja Venom Strychnos Nux-vomica Seed Phosphorus Pulsatilla Vulgaris Salix Nigra Bark Sanguinaria Canadensis Root Sepia Officinalis Juice Echinacea, Unspecified Valerian
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Menopause  Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

Purpose

Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.


Medication Information

Purpose

Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

Description

Menopause  Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

Package Label

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children. 

Questions Section

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section

Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section

Menopause  Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

Dosage & Administration Section

Directions:  Adults, take 6 pellets orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Elaps corallinus 30x, Agnus 10x, Angelica sinensis radix 10x, Arsenicum alb. 10x, Bryonia 10x, Cantharis 10x, Caulophyllum 10x, Cimicifuga 10x, Cinchona 10x, Crotalus horridus 10x, Damiana 10x, Glonoinum 10x, Helonias dioica 10x, Ignatia 10x, Kali carb. 10x, Lachesis 10x, Naja 10x, Nux vom.10x, Phosphorus 10x, Pulsatilla 10x, Salix nigra 10x, Sanguinaria 10x, Sepia 10x, Echinacea 3x, Valeriana 3x.

Otc Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

Otc Keep Out of Reach of Children Section

Keep out of reach of children


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children. 

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Menopause  Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions:  Adults, take 6 pellets orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Elaps corallinus 30x, Agnus 10x, Angelica sinensis radix 10x, Arsenicum alb. 10x, Bryonia 10x, Cantharis 10x, Caulophyllum 10x, Cimicifuga 10x, Cinchona 10x, Crotalus horridus 10x, Damiana 10x, Glonoinum 10x, Helonias dioica 10x, Ignatia 10x, Kali carb. 10x, Lachesis 10x, Naja 10x, Nux vom.10x, Phosphorus 10x, Pulsatilla 10x, Salix nigra 10x, Sanguinaria 10x, Sepia 10x, Echinacea 3x, Valeriana 3x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

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


Raw Label Data

All Sections (JSON)