Menstrual - PMS description, usages, side effects, indications, overdosage, supplying and lots more!

Menstrual - PMS

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Menstrual - PMS

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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:  Ages 12 and up, take 6 pellets orally as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

Angelica sinensis radix 20x, Arsenicum alb. 20x, Bryonia 20x, Caulophyllum 20x, Cimicifuga 20x, Cinchona 20x, Dioscorea 20x, Folliculinum 20x, Gelsemium 20x, Lachesis 20x, Lilium 20x, Lycopodium 20x, Millefolium 20x, Nux vom. 20x, Pulsatilla 20x, Sabina 20x, Secale 20x, Sepia 20x, Thlaspi 20x, Viburnum op. 20x, Zingiber 20x, Dioscorea 8x, Echinacea 8x, Valeriana 8x, Dioscorea 3x, Echinacea 3x, Valeriana 3x.

PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

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.

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.

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

Menstrual - PMS

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

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55714-4449
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ANGELICA SINENSIS ROOT 20 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 20 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 20 [hp_X]
CAULOPHYLLUM THALICTROIDES ROOT 20 [hp_X]
BLACK COHOSH BLACK COHOSH 20 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 20 [hp_X]
DIOSCOREA VILLOSA TUBER DIOSCOREA VILLOSA TUBER 20 [hp_X]
ESTRONE ESTRONE 20 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT 20 [hp_X]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 20 [hp_X]
LILIUM LANCIFOLIUM WHOLE FLOWERING LILIUM LANCIFOLIUM WHOLE FLOWERING 20 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 20 [hp_X]
ACHILLEA MILLEFOLIUM 20 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 20 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 20 [hp_X]
Juniperus Sabina Leafy Twig JUNIPERUS SABINA LEAFY TWIG 20 [hp_X]
CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM 20 [hp_X]
SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE 20 [hp_X]
Capsella Bursa-pastoris CAPSELLA BURSA-PASTORIS 20 [hp_X]
Viburnum Opulus Bark VIBURNUM OPULUS BARK 20 [hp_X]
GINGER 20 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 8 [hp_X]
Valerian VALERIAN 8 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-4449-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-4449-2 56.7 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-01


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