Label: PASSI VALERIAN- arnica montana, gelsemium, kali phos, moschus, passiflora, valeriana 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 July 31, 2025

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  • DOSAGE & ADMINISTRATION

    25-30 drops in half cup of water an hour before going to bed

  • ACTIVE INGREDIENT

    arnica montana, gelsemium, kali phos, moschus, passiflora, valeriana

  • INACTIVE INGREDIENT

    ALCOHOL

  • INDICATIONS & USAGE

    A traditional homoeopathic formula for the temporary relieve of sleep disturbances due to symptoms of mild anxiety, for detail please read the enclosed package.
    (Product information leaflet).

  • PURPOSE

    A traditional homoeopathic formula for the temporary relieve of sleep disturbances due to symptoms of mild anxiety, for detail please read the enclosed package.
    (Product information leaflet).

  • CONTRAINDICATIONS

    Care & contra-indications:
    This is a homoeopathic remedy, no contra-indications are established.

  • WARNINGS

    Precautions/storage:
    Keep away from children and store at cool and dry place.

  • KEEP OUT OF REACH OF CHILDREN

    Precautions/storage:
    Keep away from children and store at cool and dry place.

  • PRINCIPAL DISPLAY PANEL

    Passi Valerian

  • INGREDIENTS AND APPEARANCE
    PASSI VALERIAN 
    arnica montana, gelsemium, kali phos, moschus, passiflora, valeriana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85816-6012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA4 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_C]  in 1 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 1 mL
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE6 [hp_X]  in 1 mL
    MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7) (MOSCHUS MOSCHIFERUS MUSK SAC RESIN - UNII:8KFK4W7KP7) MOSCHUS MOSCHIFERUS MUSK SAC RESIN6 [hp_X]  in 1 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 0.96 mL  in 1 mL
    Product Characteristics
    Colorwhite (transparent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85816-6012-130 mL in 1 BOTTLE, GLASS; Type 6: Drug/Biologic Combination01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2015
    Labeler - BM Private Limited (645599762)
    Establishment
    NameAddressID/FEIBusiness Operations
    BM PRIVATE LIMITED645599762manufacture(85816-6012)
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