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): 55714-2222-0, 55714-2222-1, 55714-2222-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC 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 March 1, 2011
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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 - 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
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - 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 OTC DRUG Item Code (Source) NDC:55714-2222 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 15 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 15 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 15 [hp_X] in 1 mL Caulophyllum Thalictroides Root (UNII: JTJ6HH6YEH) (Caulophyllum Thalictroides Root - UNII:JTJ6HH6YEH) Caulophyllum Thalictroides Root 15 [hp_X] in 1 mL Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh 15 [hp_X] in 1 mL Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 15 [hp_X] in 1 mL Dioscorea Villosa Tuber (UNII: IWY3IWX2G8) (Dioscorea Villosa Tuber - UNII:IWY3IWX2G8) Dioscorea Villosa Tuber 15 [hp_X] in 1 mL Estrone (UNII: 2DI9HA706A) (Estrone - UNII:2DI9HA706A) Estrone 15 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 15 [hp_X] in 1 mL Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 15 [hp_X] in 1 mL Lilium Lancifolium Whole Flowering (UNII: X67Z2963PI) (Lilium Lancifolium Whole Flowering - UNII:X67Z2963PI) Lilium Lancifolium Whole Flowering 15 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 15 [hp_X] in 1 mL Achillea Millefolium (UNII: 2FXJ6SW4PK) (Achillea Millefolium - UNII:2FXJ6SW4PK) Achillea Millefolium 15 [hp_X] in 1 mL Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 15 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 15 [hp_X] in 1 mL Juniperus Sabina Leafy Twig (UNII: Z5BEX9K2G1) (Juniperus Sabina Leafy Twig - UNII:Z5BEX9K2G1) Juniperus Sabina Leafy Twig 15 [hp_X] in 1 mL Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium 15 [hp_X] in 1 mL Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 15 [hp_X] in 1 mL Capsella Bursa-pastoris (UNII: W0X9457M59) (Capsella Bursa-pastoris - UNII:W0X9457M59) Capsella Bursa-pastoris 15 [hp_X] in 1 mL Viburnum Opulus Bark (UNII: T1UG6H6805) (Viburnum Opulus Bark - UNII:T1UG6H6805) Viburnum Opulus Bark 15 [hp_X] in 1 mL Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger 15 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 mL Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 3 [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:55714-2222-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-2222-2 59.14 mL in 1 BOTTLE, GLASS 3 NDC:55714-2222-0 .5 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2222)