Insomulex
FDA Label NDC 49726-026

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 Insomulex (NDC 49726-026). 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.

Active Ingredients (Per Dose)

Aesculus hipp, flos, Baryta carb, Cypripedium, Hyoscyamus, Mag carb, Sulphur HPUS

Ambra, Ignatia HPUS

Arsenicum alb HPUS

Avena, Cocculus, Coffea cruda, Gelsemium, Kali phos HPUS

Camphora, Kali brom, Passiflora, Scutellaria HPUS

Cinchona HPUS

Muriaticum ac, Valeriana, Zinc met HPUS

Nat phos HPUS

Each ingredient contains equal volumes of 10X, 30X, and LM1 potencies.  The letters "HPUS" indicate that the components in thsi prodct are officially monographed in the Homeopathic Pharmacopeia of the United States.

Product indications are based on Homeopathic Materia Medica.

Purpose

Aesculus hipp, flos, Baryta carb, Cypripedium, Hyoscyamus, Mag carb, Sulphur HPUS.....................................Trouble sleeping

Ambra, Ignatia HPUS...................................................................................................................................................Worry

Arsenicum alb HPUS....................................................................................................................................................Fear

Avena, Cocculus, Coffea cruda, Gelsemium, Kali phos HPUS....................................................................Nervous Exhaustion

Camphora, Kali brom, Passiflora, Scutellaria HPUS.............................................................................................Restlessness

Cinchona HPUS................................................................................................................................................Anxiousness

Muriaticum ac, Valeriana, Zinc met HPUS.................................................................................................Tossing and Turning

Nat phos HPUS..............................................................................................................Tiredness during day, staying up late



Each 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. Indications are based on Homeopathic Materia Medica.

Uses

For the temporary relief of symptoms commonly associated with insomnia, including:

  • worry
  • restless tossing
  • light sleeping
  • overactive mind

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, use only on the advice of a physician.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Directions


  • add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink, or dispense Insomulex directly into mouth.
  • for optimal benefit, use Insomulex prior to bedtime, naptime, or returning to either after a disruption.
  • Dosage by Weight:

    30-50 lbs (13.6-22.6 kg)         1/2 mL

    50+ lbs (22.6+ kg)                 1 mL



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 give us a call toll-free at 1.800.875.0850. Monday through Friday 9am-5pm.

Description

  • 30-day supply
  • dropper included
  • Insomulex is made without alcohol or sugar. No gluten added.
  • Mftd for: HelloLife, LLC.
    4460 44th St. SE, Ste. C-600
    Grand Rapids, MI 49512
    FDA Pharmaceutical Establishment
    #1053442, #3009727070
    www.insomulex.com


Principal Display Panel

NDC 49726-026-02

INSOMULEXTM

Insomnia Symptom Relief

For temporary relief of symptoms commonly associated with insomnia, including:

  • worry
  • restless tossing
  • light sleeping
  • overactive mind
  • 2 FL OZ (59 mL)

    Homeopathic (OTC) Medicine


Insomulexcarton (Insomulexcarton)

Insomulexcarton (Insomulexcarton)





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