Label: SUBTILIS- bacillus subtilis liquid

  • 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 18, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Medicine

  • Indications

    For temporary relief of constipation, mild cramping, bloating and gas

  • Dosage

    5 drops, three times per week.

  • Active Ingredient

    Bacillus subtilis 6X

  • Inactive Ingredients

    Purified water, sodium chloride, potassium sorbate.

  • Warning

    If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing, seek the advice of a health care professional before using this product.

    Keep this and all medications out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • Tamper Evident

    Do not use product if the tamper evident strip is broken or removed from the base of the cap.

  • SPL UNCLASSIFIED SECTION

    To report serious adverse events, call: 1-623-582-3110

    Manufactured for and distributed by:
    USPharmaCo Distribution Ltd.
    2205 W. Lone Cactus Drive #19, Phoenix, AZ 85027
    www.uspharmaco.com
    info@uspharmaco.com

    Made in Canada

  • PRINCIPAL DISPLAY PANEL - 5 mL Label

    SUBTILIS DROPS 6X

    Homeopathic Medicine 0.17 fl. oz. (5ml)

    Indications: For temporary relief of constipation, mild cramping, bloating and gas
    Dosage: 5 drops, three times per week.
    Active Ingredient: Bacillus subtilis 6X
    Inactive Ingredients: Purified water, sodium chloride, potassium sorbate.
    Warning: If symptoms persist more than a few days, contact a licensed practitioner. As with any
    drug, if you are pregnant or nursing, seek the advice of a health care professional before using this
    product. Keep this and all medications out of reach of children. In case of overdose, get medical help
    or contact a Poison Control Center right away. Protect from light and heat.
    Tamper Evident: Do not use product if the tamper evident strip is broken or removed from the base
    of the cap.
    To report serious adverse events, call: 1-623-582-3110

    Principal Display Panel - 5 mL Label
  • INGREDIENTS AND APPEARANCE
    SUBTILIS 
    bacillus subtilis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49693-2301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacillus subtilis (UNII: 8CF93KW41W) (Bacillus subtilis - UNII:8CF93KW41W) Bacillus subtilis6 [hp_X]  in 5 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49693-2301-11 in 1 BOX
    15 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/15/2009
    Labeler - USPharmaCo (145322622)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaMed256799461MANUFACTURE
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