AVENA VALERIANA PELLET [URIEL PHARMACY INC]

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AVENA VALERIANA PELLET [URIEL PHARMACY INC]
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NDC 48951-1279-2
Set ID f13e2342-fee0-4a29-9db2-06bf81b8991d
Category HUMAN OTC DRUG LABEL
Packager Uriel Pharmacy Inc
Generic Name
Product Class
Product Number
Application Number
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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients: Avena (Oats) 3X, Valeriana (Valerian) 3X, Conchae (Oyster shells) 7X, Phosphorus (Yellow phosphorus) 30X, Sulfur 30X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Organic sucrose, Lactose

  • PURPOSE

    Use: Temporary relief for sleeplessness and nerves.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. Do not use if allergic to any ingredient. Contains traces of lactose. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

  • QUESTIONS

    Questions? Call 866.642.2858
    Uriel, East Troy, WI 53120
    www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    AvenaValerianaPellets

  • INGREDIENTS AND APPEARANCE
    AVENA VALERIANA 
    avena valeriana pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1279
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]
    OSTREA EDULIS SHELL (UNII: 49OY13BE7Z) (OSTREA EDULIS SHELL - UNII:49OY13BE7Z) OSTREA EDULIS SHELL7 [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)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (round) Size3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1279-21350 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc043471163manufacture(48951-1279)
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