Label: INSOMULEX INSOMNIA SYMPTOM RELIEF- aesculus hipp, flos, ambra, arsenicum alb, avena, baryta carb, camphora, cinchona, cocculus, coffea cruda, cypripedium, gelsemium, hyoscyamus, ignatia, kali brom, kali phos, mag carb, muriaticum ac, nat phos, passiflora, scutellaria, sulphur, valeriana, zinc met liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 26, 2018

If you are a consumer or patient please visit this version.

  • 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

    When using this product, use only as directed.

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

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

    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 info@hellolife.net 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

    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


    InsomulexCarton





  • INGREDIENTS AND APPEARANCE
    INSOMULEX  INSOMNIA SYMPTOM RELIEF
    aesculus hipp, flos, ambra, arsenicum alb, avena, baryta carb, camphora, cinchona, cocculus, coffea cruda, cypripedium, gelsemium, hyoscyamus, ignatia, kali brom, kali phos, mag carb, muriaticum ac, nat phos, passiflora, scutellaria, sulphur, valeriana, zinc met liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49726-026
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]  in 59 mL
    AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C) AMBERGRIS10 [hp_X]  in 59 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]  in 59 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE10 [hp_X]  in 59 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)10 [hp_X]  in 59 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 59 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED10 [hp_X]  in 59 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN10 [hp_X]  in 59 mL
    CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT10 [hp_X]  in 59 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE10 [hp_X]  in 59 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 59 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE10 [hp_X]  in 59 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB) HYDROCHLORIC ACID10 [hp_X]  in 59 mL
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE10 [hp_X]  in 59 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 59 mL
    SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN10 [hp_X]  in 59 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49726-026-021 in 1 CARTON08/15/2012
    159 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/2012
    Labeler - Hello Life, Inc. (065619378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hello Life, Inc.065619378relabel(49726-026) , repack(49726-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(49726-026)