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.

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

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 liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:55714-4448
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4448)