Menstrual - Pms Pellet
FDA Label NDC 55714-2482

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Menstrual - Pms (NDC 55714-2482). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

Package Label (N012 P01)

Package Label (N012 P01)

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