Label: AVENA VALERIANA NERVE RELIEF- oat valerian root oyster shell calcium carbonate, crude phosphorus sulfur pellet

  • 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 1, 2009

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  • Purpose

    Uses: Temporarily relieves sleeplessness, nerves.

  • Dosage & Administration

    Directions: For sleep, dissolve under tongue at bedtime. Repeat if needed. Age 12 and older: 10 pellets. Ages 2-11: 5 pellets. For stressed nerves during the day, take up to every 2 hours. Age 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: ask a doctor.

  • OTC-Active Ingredient

    Active Ingredients: Avena e pl. tota 3X, Valeriana e rad. 3X, Conchae 7X, Phosphorus 30X, Sulphur 30X, all HPUS.

  • Inactive Ingredient

    Inactive Ingredient: Sucrose

  • Keep out of reach of children

    KEEP OUT OF REACH OF CHILDREN.

  • Do not use section

    Warnings:  Do not use if allergic to any ingredient. Do not use if safety seal is broken or missing.

  • Ask doctor section

    Consult a doctor if you are diabetic or intolerant of sugar, if sleeplessness persists for more than two weeks. Insomnia may be a symptom of
    a serious underlying condition.

  • Pregnancy or breast feeding section

    If you are pregnant or nursing, consult a doctor before use.

  • Questions section

    Questions? Uriel Pharmacy

    866 642-2858  East Troy, WI 53120 

    www.urielpharmacy.com

    NDC 48951-1212-2

  • Principal Display Panel

    Avena Valeriana

    Nerve Relief

    Homeopathic Pellets

    net wt. 1 oz.

    avena valeriana pellets bottle label

  • INGREDIENTS AND APPEARANCE
    AVENA VALERIANA NERVE RELIEF 
    oat valerian root oyster shell calcium carbonate, crude phosphorus sulfur pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1212
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT3 [hp_X]
    VALERIAN ROOT (UNII: 4M98M04Z3Z) (VALERIAN ROOT - UNII:4M98M04Z3Z) VALERIAN ROOT3 [hp_X]
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE7 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (round) Size3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1212-21350 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2009
    Labeler - Uriel Pharmacy Inc (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc043471163manufacture
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