Label: SILICON DIOXIDE- silicea tablet

  • NDC Code(s): 0360-0347-02
  • Packager: STANDARD HOMEOPATHIC COMPANY
  • 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 May 31, 2017

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  • INDICATIONS & USAGE

    SKIN ERUPTIONS OR COUGH

    1

  • WARNINGS

    Do not use if cap band is missing or broken. If you are pregnant or nursing, consult a licensed health care professional before using this product. If symptoms persist for 7 days or worsen, contact a licensed practitioner. To be used according to label indications and/or standard homeopathic indications

    2

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of the reach of children.

    3

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: ADULTS: Dissolve 4 tablets under the tongue 4 times a day.

    CHILDREN: 2 tablets as above.

    4

  • INACTIVE INGREDIENT

    In a base of Acacia Gum and Lactose N.F.

    6

  • QUESTIONS

    800-624-9659

    5

  • ACTIVE INGREDIENT

    SILICEA 30X

    7

  • PURPOSE

    SKIN ERUPTIONS OR COUGH

    9

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -- 500 Tablet Bottle
    Made according to the Homeopathic Pharmacopoeia of the United States since 1903.
    Warnings: Do not use if cap band is missing or broken. If you are pregnant or nursing, consult a licensed health care professional before using this product. If symptoms persist for 7 days or worsen, contact a licensed practitioner. Keep this and all medicines out of the reach of children. To be used according to label indications and/or standard homeopathic indications.
    Standard Homeopathic Company
    Los Angeles, CA 90061
    Questions? 800-624-9659
    Standard Homeopathic
    Made in the USA Since 1903
    NDC # 0360-0347-02
    Homeopathic Medicine
    SILICEA 30X
    SKIN ERUPTIONS OR COUGH
    500 TABLETS
    DIRECTIONS: ADULTS: Dissolve 4 tablets under the tongue 4 times a day.

    CHILDREN: 2 tablets as above.
    In a base of Acacia Gum and Lactose N.F.
    3 00360 03472 2
    Lot #: XXXXXX

    8

  • INGREDIENTS AND APPEARANCE
    SILICON DIOXIDE 
    silicea tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0360-0347
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0360-0347-02500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/17/1997
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/17/1997
    Labeler - STANDARD HOMEOPATHIC COMPANY (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    STANDARD HOMEOPATHIC COMPANY008316655manufacture(0360-0347) , pack(0360-0347) , label(0360-0347)