Label: VALERIANAHEEL- valerian and trinitrophenol and prunus spinosa flower bud and hops and hypericum perforatum and melissa officinalis and avena sativa flowering top and matricaria recutita and ammonium bromide and potassium bromide and sodium bromide liquid

  • Category: HUMAN OTC DRUG LABEL

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 February 20, 2012

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of the reach of children.
  • INDICATIONS AND USAGE

    For the temporary relief of:
    • Sleeplessness
    • Restlessness
    • Nervous tension and exhaustion


  • WARNINGS

    If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.
  • DOSAGE AND ADMINISTRATION

    Adults and children above 11 years: 10 drops orally, 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.
  • ACTIVE INGREDIENT

    Each 50 ml contains as active ingredients: Valeriana officinalis 2X 32.5 ml; Picricum acidum 6X 5 ml; Prunus spinosa 2X 2.5 ml; Humulus lupulus 2X 2.5 ml; Hypericum perforatum 3X 2.5 ml; Melissa officinalis 2X 1.5 ml; Avena sativa 2X 1 ml; Chamomilla 2X 1 ml; Ammonium bromatum 2X 0.5 ml; Kali bromatum 2X 0.5 ml; Natrum bromatum 2X 0.5 ml.
  • INACTIVE INGREDIENT

    Inactive ingredients: Ethanol, Purified Water USP.
  • PURPOSE

    Sleeplessness, Restlessness, Nervous tension and exhaustion
  • PRINCIPAL DISPLAY PANEL

    Valerianaheel Oral Drop.jpg



  • INGREDIENTS AND APPEARANCE
    VALERIANAHEEL 
    valerian and trinitrophenol and prunus spinosa flower bud and hops and hypericum perforatum and melissa officinalis and avena sativa flowering top and matricaria recutita and ammonium bromide and potassium bromide and sodium bromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-1165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN2 [hp_X]  in 50 mL
    TRINITROPHENOL (UNII: A49OS0F91S) (TRINITROPHENOL - UNII:A49OS0F91S) TRINITROPHENOL6 [hp_X]  in 50 mL
    PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W) PRUNUS SPINOSA FLOWER BUD2 [hp_X]  in 50 mL
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS2 [hp_X]  in 50 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 50 mL
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS2 [hp_X]  in 50 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_X]  in 50 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA2 [hp_X]  in 50 mL
    AMMONIUM BROMIDE (UNII: R0JB3224WS) (AMMONIUM BROMIDE - UNII:R0JB3224WS) AMMONIUM BROMIDE2 [hp_X]  in 50 mL
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06, POTASSIUM CATION - UNII:295O53K152) POTASSIUM BROMIDE2 mm  in 50 mL
    SODIUM BROMIDE (UNII: LC1V549NOM) (SODIUM CATION - UNII:LYR4M0NH37, BROMIDE ION - UNII:952902IX06) SODIUM BROMIDE2 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50114-1165-450 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/1986
    Labeler - Heel Inc (102783016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Heel Inc102783016manufacture
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