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Valerianaheel (Heel Inc)

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LIQUID 50 mL in 1 BOTTLE (50114-1165-4) Label Information

Complete Valerianaheel Information

  • 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

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:50114-1165
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 2 [hp_X]  in 50 mL
    TRINITROPHENOL (UNII: A49OS0F91S) (TRINITROPHENOL - UNII:A49OS0F91S) TRINITROPHENOL 6 [hp_X]  in 50 mL
    PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W) PRUNUS SPINOSA FLOWER BUD 2 [hp_X]  in 50 mL
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 2 [hp_X]  in 50 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 3 [hp_X]  in 50 mL
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS 2 [hp_X]  in 50 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 2 [hp_X]  in 50 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 2 [hp_X]  in 50 mL
    AMMONIUM BROMIDE (UNII: R0JB3224WS) (AMMONIUM BROMIDE - UNII:R0JB3224WS) AMMONIUM BROMIDE 2 [hp_X]  in 50 mL
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06, POTASSIUM CATION - UNII:295O53K152) POTASSIUM BROMIDE 2 mm  in 50 mL
    SODIUM BROMIDE (UNII: LC1V549NOM) (SODIUM CATION - UNII:LYR4M0NH37, BROMIDE ION - UNII:952902IX06) SODIUM BROMIDE 2 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50114-1165-4 50 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/31/1986
    Labeler - Heel Inc (102783016)
    Establishment
    Name Address ID/FEI Business Operations
    Heel Inc 102783016 manufacture