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
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, ANEMONE PULSATILLA, 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#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
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 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
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.
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
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
| 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 | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-2482-1 | 2023-11-02 | C162847 | 48780-1 | d6a99b39-b9d7-a426-e053-dadaa90af4c2 | Menstrual 2482P |
| 55714-2482-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b9d7-a426-e053-dadaa90af4c2 | Menstrual 2482P |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2482-1 | Menstrual - PMS | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2482 | 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.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231103_9c4a13c3-87ff-e833-e053-2995a90a8aba.zip |
Products#
Every source-derived product name is available through these pages.
- 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
- ANEMONE PULSATILLA
- 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 |
|---|---|
| 55714-2482 | 55714-2482-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Newton Laboratories, Inc. | 9c4a13c3-87ff-e833-e053-2995a90a8aba | 2023-11-02 | Warnings | 55714-2482-1 55714-2482 55714248201 092fe390-ff03-13f2-e063-6394a90a5221 9c4a13c3-87ff-e833-e053-2995a90a8aba |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.