Label: NOTATUM-QUENTANS- penicillium chrysogenum var. chrysogenum and penicillium glabrum suspension/ drops

  • 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 sinus (or nasal) congestion symptoms

  • Dosage

    Spray twice into each nostril three times daily.

  • Active Ingredients

    Penicillium notatum (chrysogenum) 4X and Penicillium frequentans 4X

  • 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.

  • SPL UNCLASSIFIED SECTION

    To report serious adverse events, call: 1-877-557-4276 or 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 - 10 mL Label

    NOTATUM-QUENTANS NASAL SPRAY 4X

    Homeopathic Medicine 0.34 fl. oz. (10ml)

    Indications: For temporary relief of sinus (or nasal) congestion symptoms
    Dosage: 5-10 drops, three times daily.
    Active Ingredients: Penicillium notatum (chrysogenum) 4X and Penicillium frequentans 4X
    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.
    To report serious adverse events, call: 1-877-557-4276 or 1-623-582-3110

    Principal Display Panel - 10 mL Label
  • INGREDIENTS AND APPEARANCE
    NOTATUM-QUENTANS 
    penicillium chrysogenum var. chrysogenum and penicillium glabrum suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49693-1604
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Penicillium chrysogenum var. chrysogenum (UNII: 3Y1PE1GCIG) (Penicillium chrysogenum var. chrysogenum - UNII:3Y1PE1GCIG) Penicillium chrysogenum var. chrysogenum4 [hp_X]  in 10 mL
    Penicillium glabrum (UNII: 2IN23YUE0I) (Penicillium glabrum - UNII:2IN23YUE0I) Penicillium glabrum4 [hp_X]  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49693-1604-11 in 1 BOX
    110 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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