Menstrual - pms

Menstrual - pms
SPL v2
SPL
SPL Set ID ef35a4fb-d281-aae3-c0fd-064bb161fe05
Route
ORAL
Published
Effective Date 2012-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Angelica Sinensis Root (15 [hp_X]) Arsenic Cation (3+) (3 [hp_X]) Bryonia Alba Root Caulophyllum Thalictroides Root Black Cohosh Cinchona Officinalis Bark Dioscorea Villosa Tuber Estrone Gelsemium Sempervirens Root Lachesis Muta Venom Lilium Lancifolium Whole Flowering Lycopodium Clavatum Spore Achillea Millefolium Strychnos Nux-vomica Seed Pulsatilla Vulgaris Juniperus Sabina Leafy Twig Claviceps Purpurea Sclerotium Sepia Officinalis Juice Capsella Bursa-pastoris Viburnum Opulus Bark Ginger Echinacea, Unspecified Valerian
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Menstrual - PMS  Formulated for associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings.

Purpose

 Formulated for associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings.


Medication Information

Purpose

 Formulated for associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings.

Description

Menstrual - PMS  Formulated for associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings.

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 associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings.

Inactive Ingredient Section

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

Indications & Usage Section

Menstrual - PMS  Formulated for associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Angelica sinensis radix 15x, Arsenicum alb. 15x, Bryonia 15x, Caulophyllum 15x, Cimicifuga 15x, Cinchona 15x, Dioscorea 15x, Folliculinum 15x, Gelsemium 15x, Lachesis 15x, Lilium 15x, Lycopodium 15x, Millefolium 15x, Nux vom. 15x, Pulsatilla 15x, Sabina 15x, Secale 15x, Sepia 15x, Thlaspi 15x, Viburnum op. 15x, Zingiber 15x, Dioscorea 3x, 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 associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Menstrual - PMS  Formulated for associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Angelica sinensis radix 15x, Arsenicum alb. 15x, Bryonia 15x, Caulophyllum 15x, Cimicifuga 15x, Cinchona 15x, Dioscorea 15x, Folliculinum 15x, Gelsemium 15x, Lachesis 15x, Lilium 15x, Lycopodium 15x, Millefolium 15x, Nux vom. 15x, Pulsatilla 15x, Sabina 15x, Secale 15x, Sepia 15x, Thlaspi 15x, Viburnum op. 15x, Zingiber 15x, Dioscorea 3x, 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)