SPL v6
SPL
SPL Set ID e4d43536-7ea2-4049-9ed8-446d5feb7331
Route
ORAL
Published
Effective Date 2016-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aesculus Hippocastanum Flower (10 [hp_X]) Ambergris Avena Sativa Flowering Top Barium Cation Camphor (natural) Cinchona Officinalis Bark Anamirta Cocculus Seed Arabica Coffee Bean Cypripedium Parviflorum Var. Pubescens Root Gelsemium Sempervirens Root Hyoscyamus Niger Strychnos Ignatii Seed Bromide Ion Phosphate Ion Carbonate Ion Hydrochloric Acid Passiflora Incarnata Flowering Top Arsenic Cation (3+) Scutellaria Lateriflora Sulfur Valerian Zinc
Inactive Ingredients
Citric Acid Monohydrate Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2012-08-15

Description

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.


Medication Information

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.

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





Uses

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

  • worry
  • restless tossing
  • light sleeping
  • overactive mind


Section 50565-1

Keep out of the reach of children.

Section 50566-9

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

Section 50567-7

When using this product, use only as directed.

Section 53414-9

If pregnant or breast-feeding, use only on the advice of a physician.

Warnings


Ask a doctor before use if





  • you are taking any other medications

  • you have a medical condition


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.


Principal Display Panel

NDC 49726-026-02

INSOMULEX TM

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











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.


Structured Label Content

Uses

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

  • worry
  • restless tossing
  • light sleeping
  • overactive mind


Description (34089-3)
  • 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





Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product, use only as directed.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, use only on the advice of a physician.

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.

Warnings


Ask a doctor before use if





  • you are taking any other medications

  • you have a medical condition


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? (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.


Principal Display Panel

NDC 49726-026-02

INSOMULEX TM

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











Active Ingredients (per Dose) (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.


Advanced Ingredient Data


Raw Label Data

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