Label: INSOMNIA HP- arsenic trioxide, arabica coffee bean, potassium carbonate, magnesium carbonate, strychnos nux-vomica seed, passiflora incarnata top, sepia officinalis juice, valerian 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 November 5, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*): Arsenicum Album 30X, Coffea Cruda 30X, Kali Carbonica 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X

  • INDICATIONS & USAGE

    USES: Temporarily relieves sleeplessness due to anxiousness, excitement, exhaustion, nervousness, dreams, &/or other symptoms related to insomnia.

  • WARNINGS

    WARNING:

    Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

  • DO NOT USE

    OTHER INFORMATION: Tamper Seal: "Sealed for your protection."

    Do not use if seal is broken or missing.

  • REFERENCES

    *The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

  • QUESTIONS

    QUESTIONS AND COMMENTS?

    MFG FOR: Natural Creations / Woodbine, IA / 51579 712.647.1600

    LOT:

  • PURPOSE

    USES: Temporarily relieves sleeplessness due to anxiousness, excitement, exhaustion, nervousness, dreams, &/or other symptoms related to insomnia.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0027-1

    INSOMNIA HP

    Insomnia

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    UPC: 877730001719

    Image Of Label

  • INGREDIENTS AND APPEARANCE
    INSOMNIA HP 
    arsenic trioxide, arabica coffee bean, potassium carbonate, magnesium carbonate, strychnos nux-vomica seed, passiflora incarnata top, sepia officinalis juice, valerian liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0027
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+)30 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN30 [hp_X]  in 1 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) CARBONATE ION30 [hp_X]  in 1 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) CARBONATE ION30 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]  in 1 mL
    PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP30 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 1 mL
    VALERIAN (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0027-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2007
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0027)
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