Menstrual - PMS

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-06-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:06

Label at a glance#

ProductMenstrual - PMS

Active ingredientAngelica Sinensis Root, Arsenic Trioxide, 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

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label 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

OTC - 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

ABUSE 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

OTC - 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

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.

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
16fd7d69-0da3-423a-f064-01fb62860837	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4449-1	2020-01-31	C162847	48780-1	9d75b9d0-2b06-f424-e053-dadaa90a57ce	Menstrual - PMS
55714-4449-2	2020-01-31	C162847	48780-1	9d75b9d0-2b06-f424-e053-dadaa90a57ce	Menstrual - PMS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4449-1	Menstrual - PMS	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4449-2	Menstrual - PMS	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4449	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 [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131030_064db435-6737-75ab-b84a-7590d5dbf99d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Achillea Millefolium	ACTIVE INGREDIENT	2FXJ6SW4PK	1
Angelica Sinensis Root	ACTIVE INGREDIENT	B66F4574UG	1
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Black Cohosh	ACTIVE INGREDIENT	K73E24S6X9	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Capsella Bursa-pastoris	ACTIVE INGREDIENT	W0X9457M59	1
Caulophyllum Thalictroides Root	ACTIVE INGREDIENT	JTJ6HH6YEH	1
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	1
Claviceps Purpurea Sclerotium	ACTIVE INGREDIENT	01G9XEA93N	1
Dioscorea Villosa Tuber	ACTIVE INGREDIENT	IWY3IWX2G8	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Estrone	ACTIVE INGREDIENT	2DI9HA706A	1
Gelsemium Sempervirens Root	ACTIVE INGREDIENT	639KR60Q1Q	1
Ginger	ACTIVE INGREDIENT	C5529G5JPQ	1
Juniperus Sabina Leafy Twig	ACTIVE INGREDIENT	Z5BEX9K2G1	1
Lachesis Muta Venom	ACTIVE INGREDIENT	VSW71SS07I	1
Lilium Lancifolium Whole Flowering	ACTIVE INGREDIENT	X67Z2963PI	1
Lycopodium Clavatum Spore	ACTIVE INGREDIENT	C88X29Y479	1
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	1
Sepia Officinalis Juice	ACTIVE INGREDIENT	QDL83WN8C2	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Valerian	ACTIVE INGREDIENT	JWF5YAW3QW	1
Viburnum Opulus Bark	ACTIVE INGREDIENT	T1UG6H6805	1
Achillea Millefolium	ACTIVE MOIETY	2FXJ6SW4PK	1
Angelica Sinensis Root	ACTIVE MOIETY	B66F4574UG	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Black Cohosh	ACTIVE MOIETY	K73E24S6X9	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Capsella Bursa-pastoris	ACTIVE MOIETY	W0X9457M59	1
Caulophyllum Thalictroides Root	ACTIVE MOIETY	JTJ6HH6YEH	1
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	1
Claviceps Purpurea Sclerotium	ACTIVE MOIETY	01G9XEA93N	1
Dioscorea Villosa Tuber	ACTIVE MOIETY	IWY3IWX2G8	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Estrone	ACTIVE MOIETY	2DI9HA706A	1
Gelsemium Sempervirens Root	ACTIVE MOIETY	639KR60Q1Q	1
Ginger	ACTIVE MOIETY	C5529G5JPQ	1
Juniperus Sabina Leafy Twig	ACTIVE MOIETY	Z5BEX9K2G1	1
Lachesis Muta Venom	ACTIVE MOIETY	VSW71SS07I	1
Lilium Lancifolium Whole Flowering	ACTIVE MOIETY	X67Z2963PI	1
Lycopodium Clavatum Spore	ACTIVE MOIETY	C88X29Y479	1
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	1
Sepia Officinalis Juice	ACTIVE MOIETY	QDL83WN8C2	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Valerian	ACTIVE MOIETY	JWF5YAW3QW	1
Viburnum Opulus Bark	ACTIVE MOIETY	T1UG6H6805	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

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
Angelica Sinensis Root
Arsenic Trioxide
Arsenic Cation (3+)
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
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4449	55714-4449-1, 55714-4449-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Angelica Sinensis Root	B66F4574UG	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Caulophyllum Thalictroides Root	JTJ6HH6YEH	ACTIB
Black Cohosh	K73E24S6X9	ACTIB
Cinchona Officinalis Bark	S003A158SB	ACTIB
Dioscorea Villosa Tuber	IWY3IWX2G8	ACTIB
Estrone	2DI9HA706A	ACTIB
Gelsemium Sempervirens Root	639KR60Q1Q	ACTIB
Lachesis Muta Venom	VSW71SS07I	ACTIB
Lilium Lancifolium Whole Flowering	X67Z2963PI	ACTIB
Lycopodium Clavatum Spore	C88X29Y479	ACTIB
Achillea Millefolium	2FXJ6SW4PK	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Juniperus Sabina Leafy Twig	Z5BEX9K2G1	ACTIB
Claviceps Purpurea Sclerotium	01G9XEA93N	ACTIB
Sepia Officinalis Juice	QDL83WN8C2	ACTIB
Capsella Bursa-pastoris	W0X9457M59	ACTIB
Viburnum Opulus Bark	T1UG6H6805	ACTIB
Ginger	C5529G5JPQ	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Valerian	JWF5YAW3QW	ACTIB
Sucrose	C151H8M554	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2d662d2e-30a9-46c5-6b6e-9159fb909215			064db435-6737-75ab-b84a-7590d5dbf99d	2011-06-01	Warnings	Exact identifier spl id: 2d662d2e-30a9-46c5-6b6e-9159fb909215 spl set id: 064db435-6737-75ab-b84a-7590d5dbf99d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.