FDA Label for Insomulex Insomnia Symptom Relief

View Indications, Usage & Precautions

Insomulex Insomnia Symptom Relief Product Label

The following document was submitted to the FDA by the labeler of this product Hello Life, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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







* Please review the disclaimer below.