VALERIANA OFFICINALIS (N) (VALERIAN) TINCTURE [PHYTODYNE INC.]

VALERIANA OFFICINALIS (N) (VALERIAN) TINCTURE [PHYTODYNE INC.]
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NDC 13838-1448-1
Set ID 54ca25d1-b176-4d83-b659-e026c0545231
Category HUMAN OTC DRUG LABEL
Packager Phytodyne Inc.
Generic Name
Product Class
Product Number
Application Number
  • Use

    For sleeplessness and states of restlessness

  • Directions

    Adults and children above 12 years: 2-5 drops 1-3 times daily in pure water before meals. Consult a physician for use in children under 12 years of age.

  • Ingredients

    Valeriana officinalis Ø (N)

  • INACTIVE INGREDIENT

    Alcohol: 65

  • TAMPER-EVIDENT

    Do not use if tamper evident strip is broken from base of cap.

  • WARNING

    Ask a doctor if you are pregnant or nursing.

    Keep away from children. In case of overdose, call a medical professional.

  • PRINCIPAL DISPLAY PANEL - 20 ml Bottle Label

    CERES®
    Homeopathic Medicine

    Valeriana officinalis Ø (N)

    Use: For sleeplessness and states of restlessness

    Directions : Adults and children above 12 years: 2-5
    drops 1-3 times daily in pure water before meals. Consult
    a physician for use in children under 12 years of age.

    0.67 fl.oz. (20ml)
    Lot#:1234567A
    EXP: 99.9999

    Principal Display Panel - 20 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    VALERIANA OFFICINALIS (N) 
    valerian tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13838-1448
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13838-1448-120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/01/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC10/01/2005
    Labeler - Phytodyne Inc. (164980927)

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