FDA.reportPublic FDA data

Menstrual - PMS

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:44

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

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: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

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

 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

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.  

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. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

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
55714-2222-02020-01-31C16284748780-19d75b9d1-1a79-f424-e053-dadaa90a57ceMenstrual - PMS
55714-2222-12020-01-31C16284748780-19d75b9d1-1a79-f424-e053-dadaa90a57ceMenstrual - PMS
55714-2222-22020-01-31C16284748780-19d75b9d1-1a79-f424-e053-dadaa90a57ceMenstrual - PMS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2222-0Menstrual - PMS.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2222-1Menstrual - PMS29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2222-2Menstrual - PMS59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2222MENSTRUAL - 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 [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130726_ef35a4fb-d281-aae3-c0fd-064bb161fe05.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Achillea MillefoliumACTIVE INGREDIENT2FXJ6SW4PK2
Angelica Sinensis RootACTIVE INGREDIENTB66F4574UG2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Black CohoshACTIVE INGREDIENTK73E24S6X92
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Capsella Bursa-pastorisACTIVE INGREDIENTW0X9457M592
Caulophyllum Thalictroides RootACTIVE INGREDIENTJTJ6HH6YEH2
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB2
Claviceps Purpurea SclerotiumACTIVE INGREDIENT01G9XEA93N2
Dioscorea Villosa TuberACTIVE INGREDIENTIWY3IWX2G82
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
EstroneACTIVE INGREDIENT2DI9HA706A2
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q2
GingerACTIVE INGREDIENTC5529G5JPQ2
Juniperus Sabina Leafy TwigACTIVE INGREDIENTZ5BEX9K2G12
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lilium Lancifolium Whole FloweringACTIVE INGREDIENTX67Z2963PI2
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
ValerianACTIVE INGREDIENTJWF5YAW3QW2
Viburnum Opulus BarkACTIVE INGREDIENTT1UG6H68052
Achillea MillefoliumACTIVE MOIETY2FXJ6SW4PK2
Angelica Sinensis RootACTIVE MOIETYB66F4574UG2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Black CohoshACTIVE MOIETYK73E24S6X92
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Capsella Bursa-pastorisACTIVE MOIETYW0X9457M592
Caulophyllum Thalictroides RootACTIVE MOIETYJTJ6HH6YEH2
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB2
Claviceps Purpurea SclerotiumACTIVE MOIETY01G9XEA93N2
Dioscorea Villosa TuberACTIVE MOIETYIWY3IWX2G82
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
EstroneACTIVE MOIETY2DI9HA706A2
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q2
GingerACTIVE MOIETYC5529G5JPQ2
Juniperus Sabina Leafy TwigACTIVE MOIETYZ5BEX9K2G12
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lilium Lancifolium Whole FloweringACTIVE MOIETYX67Z2963PI2
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
ValerianACTIVE MOIETYJWF5YAW3QW2
Viburnum Opulus BarkACTIVE MOIETYT1UG6H68052
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-222255714-2222-1, 55714-2222-2, 55714-2222-0

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
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
Pulsatilla VulgarisI76KB35JEVACTIB
Juniperus Sabina Leafy TwigZ5BEX9K2G1ACTIB
Claviceps Purpurea Sclerotium01G9XEA93NACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Capsella Bursa-pastorisW0X9457M59ACTIB
Viburnum Opulus BarkT1UG6H6805ACTIB
GingerC5529G5JPQACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
ValerianJWF5YAW3QWACTIB
Alcohol3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6b236223-d5f5-813b-5de9-2f3e11c9f49bef35a4fb-d281-aae3-c0fd-064bb161fe052011-03-01WarningsExact identifier
spl id: 6b236223-d5f5-813b-5de9-2f3e11c9f49b
spl set id: ef35a4fb-d281-aae3-c0fd-064bb161fe05

Reported adverse events (FAERS/openFDA)#

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