Premensa
FDA Label NDC 49726-016

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hello Life, Inc. for the product Premensa (NDC 49726-016). 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 active ingredients (per dose), purpose, uses, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Per Dose)

Apis mellifica HPUS
Chamomilla HPUS
Cimicifuga racemosa HPUS
Cyclamen europaeum HPUS
Helonias dioica HPUS
Ignatia amara HPUS
Lac caninum HPUS
Lycopodium clavatum HPUS
Natrum muriaticum HPUS
Nux vomica HPUS
Platinum metallicum HPUS
Sepia HPUS

Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.  Product indications are based on Homeopathic Materia Medica.

Purpose

Apis mellifica HPUS..…………………………Cramps
Chamomilla HPUS…………………………….Sensitivity
Cimicifuga racemosa HPUS.……………......Migraines
Cyclamen europaeum HPUS………….….....Headaches
Helonias dioica HPUS………………………..Pain/weakness
Ignatia amara HPUS.…………………..……..Mood swings
Lac caninum HPUS.…………………………..Weakness
Lycopodium clavatum HPUS..…..……….....Excessive hunger
Natrum muriaticum HPUS…………………....Water retention
Nux vomica HPUS…………………………….Sensitivity
Platinum metallicum HPUS……………….....Irritability
Sepia HPUS……………..……………………..Hot flashes

Uses

 to temporarily relieve symptoms commonly associated with PMS, such as:

  • exhaustion
  • dullness
  • drowsiness
  • muscle weakness

Warnings

Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition

Otc - When Using

When using this product use only as directed.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist or worsen.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Directions

Dispense Premensa directly into mouth, or add recommended dosage into 8-12 oz purified (non-chlorinated) water and drink. Safe for ages 2 and up.

Recommended Dosage


      1 mL twice per day
          -or as needed*

*Excessive dosing may cause mild digestive discomfort.

Other Information

  • do not use if tamper seal is broken
  • store in a cool, dry place
  • product must not come in contact with metal 
  • do not store next to electrical devices or appliances

Inactive Ingredients

citric acid, potassium sorbate, purified ionized mineral water.

Questions Or Comments?

You can email us at [email protected] or call us toll-free at 1.800.875.0850 Monday through Friday, 9am-5pm ET.

Description

  • 30-day supply
  • dropper included
  • Premensa is made without alcohol or sugar; no gluten added.


    • Mftd for: HelloLife, Inc.
    4460 44th St. SE, Ste. C-600
    Grand Rapids, MI 49512
    FDA Pharmaceutical Establishment #1053442, #3009727070
    www.premensa.com

Principal Display Panel

NDC 49726-016-02

PREMENSA®

PMS Symptom Relief


To temporarily relieve symptoms commonly associated with PMS, such as:

  • cramps
  • nausea
  • bloating
  • exhaustion


    • 2 fl. oz (59 mL)

    Homeopathic (OTC) Medicine

    Premensacarton (Premensacarton)

    Premensacarton (Premensacarton)

* Please review the disclaimer below.