VALERIANA OFFICINALIS (VALERIAN) GRANULE [SEROYAL USA]

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VALERIANA OFFICINALIS (VALERIAN) GRANULE [SEROYAL USA]
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NDC 62106-9130-4
Set ID 173eac38-94ec-5b3d-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Seroyal USA
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Active Ingredients

    VALERIANA OFFICINALIS 30K GR

    VALERIANA OFFICINALIS 5CH GR

    VALERIANA OFFICINALIS 7CH GR

  • PURPOSE

    Indications

    For the temporary relief of sleeplessness and
    nervousness

  • WARNINGS

    Warning:
    If pregnant or breastfeeding, ask a health professional before use.
    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Lactose,
    sucrose.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • INDICATIONS & USAGE

    Indications

    For the temporary relief of sleeplessness and
    nervousness

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • PRINCIPAL DISPLAY PANEL

    62106-9130

    UNDA
    Do not use if label perforation is broken
    Homeopathic Remedy
    NDC : 62106-9130-4
    VALERIANA OFFICINALIS
    Valerian
    140 granules
    Indications

    For the temporary relief of sleeplessness and
    nervousness

  • INGREDIENTS AND APPEARANCE
    VALERIANA OFFICINALIS 
    valerian granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-9130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-9130-410 in 1 CARTON05/29/2015
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-9130)
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