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 liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-4448-1, 55714-4448-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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
- INACTIVE INGREDIENT SECTION
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QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- PREGNANCY OR BREAST FEEDING SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
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 liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55714-4448 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Angelica Sinensis Root (UNII: B66F4574UG) (Angelica Sinensis Root - UNII:B66F4574UG) Angelica Sinensis Root 20 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 20 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 20 [hp_X] in 1 mL Caulophyllum Thalictroides Root (UNII: JTJ6HH6YEH) (Caulophyllum Thalictroides Root - UNII:JTJ6HH6YEH) Caulophyllum Thalictroides Root 20 [hp_X] in 1 mL Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh 20 [hp_X] in 1 mL Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 20 [hp_X] in 1 mL Dioscorea Villosa Tuber (UNII: IWY3IWX2G8) (Dioscorea Villosa Tuber - UNII:IWY3IWX2G8) Dioscorea Villosa Tuber 20 [hp_X] in 1 mL Estrone (UNII: 2DI9HA706A) (Estrone - UNII:2DI9HA706A) Estrone 20 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 20 [hp_X] in 1 mL Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 20 [hp_X] in 1 mL Lilium Lancifolium Whole Flowering (UNII: X67Z2963PI) (Lilium Lancifolium Whole Flowering - UNII:X67Z2963PI) Lilium Lancifolium Whole Flowering 20 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 20 [hp_X] in 1 mL Achillea Millefolium (UNII: 2FXJ6SW4PK) (Achillea Millefolium - UNII:2FXJ6SW4PK) Achillea Millefolium 20 [hp_X] in 1 mL Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 20 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 20 [hp_X] in 1 mL Juniperus Sabina Leafy Twig (UNII: Z5BEX9K2G1) (Juniperus Sabina Leafy Twig - UNII:Z5BEX9K2G1) Juniperus Sabina Leafy Twig 20 [hp_X] in 1 mL Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium 20 [hp_X] in 1 mL Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 20 [hp_X] in 1 mL Capsella Bursa-pastoris (UNII: W0X9457M59) (Capsella Bursa-pastoris - UNII:W0X9457M59) Capsella Bursa-pastoris 20 [hp_X] in 1 mL Viburnum Opulus Bark (UNII: T1UG6H6805) (Viburnum Opulus Bark - UNII:T1UG6H6805) Viburnum Opulus Bark 20 [hp_X] in 1 mL Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger 20 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 8 [hp_X] in 1 mL Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 8 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4448-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-4448-2 59.14 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-4448)
