Label: SINUS BUSTER- capsicum annuum spray

  • 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 April 20, 2010

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  • PURPOSE

    Capsicum annuum........Relieves sinus and headache symptoms; relieves nasal congestion

  • INDICATIONS & USAGE

    Uses:   For the Temporary Relief of:

    • Sinus Congestion
    • Nasal Congestion
    • Sinus Pressure and Headache
  • WARNINGS

    For nasal use only.  Upon initial use, you will experience a powerful sensation which lasts a few seconds.  This sensation is inherent to the process that allows the capsaicin to work.  Temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may result.

  • ASK DOCTOR

    Ask a doctor before use if you have:

    •  ever had any medical procedures relating to your nose or sinuses, or you're susceptible to nose bleeds
    •  allergies to any of the ingredients.
  • WHEN USING

    When using this product:

    • Avoid contact with the eyes, In case of accidental contact with eyes, flush with water (and immediately seek professional help).
    • The use of this container by more than one person may spread infection.
  • STOP USE

    Stop use and ask doctor if symptoms persist more than two weeks or worsen or if you experience dizziness or hear palpitations.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children 12 years of age and older:  use as needed at the first sign of symptoms.  Pump 1-3 times in each nostril.
    • Children under 12 years of age:  Consult a doctor before use.

    To use pump:  Shake well.  Remove cap and safety clip.  Hold with thumb at bottom of bottle and place nozzle between fingers.  Before using the first time, prime pump by depressing several times.  Insert nozzle into nostril and firmly depress rim.  Sniff deeply.

  • STORAGE AND HANDLING

    • Store at room temperature 15-29 degrees C (59-84 degrees F)
    • Retain carton for future reference on full labeling
  • INACTIVE INGREDIENT

    Ascorbic Acid (Crystallized Vitamin C), Eucalyptol, Purified Water, Rosemary Extract, Sea Salt, Vegetable Glycerin

  • QUESTIONS

    Questions?  Call 1-877-981-4328

    Find us on the web at: www.BusterBrands.com

  • PRINCIPAL DISPLAY PANEL

    100%  Natural Chemical Free

    Non-drowsy

    No Known Drug Interactions

    Non-habit Forming

    Relieves:

    • Sinus Congestion
    • Nasal Congestion
    • Sinus Pressure and Headache
    made with Capsaicin Pepper

    Made in the USA
    Not tested on Animals

    Distributed by:
    SiCap LLC
    Albany New York 12205
    A wholly owned subsidiary of Dynova Laboratories
    www.BusterBrands.com


    Sinus Buster Label

  • INGREDIENTS AND APPEARANCE
    SINUS BUSTER 
    capsicum annuum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22955-014
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RED PEPPER (UNII: 6M47G7C4SY) (RED PEPPER - UNII:6M47G7C4SY) RED PEPPER4 [hp_X]  in 20 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22955-014-2020 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/31/2008
    Labeler - SiCap Industries LLC (170665298)
    Registrant - SiCap Industries LLC (170665298)
    Establishment
    NameAddressID/FEIBusiness Operations
    SiCap Industries LLC170665298manufacture
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