Menopause 4800l

Menopause 4800l
SPL v2
SPL
SPL Set ID 995f6b76-b98e-0d32-e053-2995a90a14fe
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Crotalus Horridus Horridus Venom (15 [hp_X]) Strychnos Ignatii Seed (20 [hp_X]) Turnera Diffusa Leafy Twig (11 [hp_X]) Nitroglycerin (35 [hp_X]) Chamaelirium Luteum Root Carbonate Ion Lachesis Muta Venom Naja Naja Venom Strychnos Nux-vomica Seed Phosphorus Anemone Pulsatilla Salix Nigra Bark Sanguinaria Canadensis Root Sepia Officinalis Juice Echinacea, Unspecified Valerian Micrurus Corallinus Venom Chaste Tree Fruit Angelica Sinensis Root Arsenic Cation (3+) Bryonia Alba Root Lytta Vesicatoria Caulophyllum Thalictroides Root Black Cohosh Cinchona Officinalis Bark
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

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

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section

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

Dosage & Administration Section

Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional.

Otc Active Ingredient Section

Equal parts of Echinacea 11x, Valeriana officinalis 11x, Agnus castus 15x, Angelica sinensis radix 15x, Bryonia 15x, Cantharis 15x, Caulophyllum thalictroides 15x, Cimicifuga racemosa 15x, Cinchona officinalis 15x, Crotalus horridus 15x, Damiana 15x, Glonoinum 15x, Helonias dioica 15x, Ignatia amara 15x, Kali carbonicum 15x, Lachesis mutus 15x, Naja tripudians 15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Sanguinaria canadensis 15x, Sepia 15x, Arsenicum album 20x, Nux vomica 20x, Elaps corallinus 35x.

Otc Pregnancy Or Breast Feeding Section

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

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)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 11x, Valeriana officinalis 11x, Agnus castus 15x, Angelica sinensis radix 15x, Bryonia 15x, Cantharis 15x, Caulophyllum thalictroides 15x, Cimicifuga racemosa 15x, Cinchona officinalis 15x, Crotalus horridus 15x, Damiana 15x, Glonoinum 15x, Helonias dioica 15x, Ignatia amara 15x, Kali carbonicum 15x, Lachesis mutus 15x, Naja tripudians 15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Sanguinaria canadensis 15x, Sepia 15x, Arsenicum album 20x, Nux vomica 20x, Elaps corallinus 35x.

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

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

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)