FDA.reportPublic FDA data

Menstrual - PMS

Manufacturer
Newton Laboratories, Inc.
Effective date
2023-11-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:23:00

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Valeriana 6x, 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.

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding , ask a doctor before use.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

PACKAGE LABEL

Label Images#

N012-P01
N012-P01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
16fd7d69-0da3-423a-f064-01fb62860837Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2482-12023-11-02C16284748780-1d6a99b39-b9d7-a426-e053-dadaa90af4c2Menstrual 2482P
55714-2482-12022-01-28C16284748780-1d6a99b39-b9d7-a426-e053-dadaa90af4c2Menstrual 2482P

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2482-1Menstrual - PMS28 g in 1 BOTTLE, GLASSPELLET283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2482MENSTRUAL - 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.]3Current NDC, Legacy NDC, 1 package rows20231103_9c4a13c3-87ff-e833-e053-2995a90a8aba.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-248255714-2482-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
ANGELICA SINENSIS ROOTB66F4574UGACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
BLACK COHOSHK73E24S6X9ACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
DIOSCOREA VILLOSA TUBERIWY3IWX2G8ACTIB
ESTRONE2DI9HA706AACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
JUNIPERUS SABINA LEAFY TWIGZ5BEX9K2G1ACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
CAPSELLA BURSA-PASTORISW0X9457M59ACTIB
VIBURNUM OPULUS BARKT1UG6H6805ACTIB
GINGERC5529G5JPQACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
VALERIANJWF5YAW3QWACTIB
SUCROSEC151H8M554IACT

Complete SPL Sections#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Valeriana 6x, 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.

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding , ask a doctor before use.

OTC - 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

Source Document#

Source XML