Label: DIZZIFREE- bryonia, cocculus, gelsemium, lobelia inf 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 November 10, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • PRINCIPAL DISPLAY PANEL

    DizziFree Label

  • HPUS Active Ingredients

    Each dose contains equal volumes of each ingredient in 30C potency: Bryonia, Cocculus, Gelsemium, Lobelia inf.

  • Uses

    *Homeopathic remedy for the temporary symptom relief of dizziness and nausea. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

  • Warnings

    If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children.

  • Directions

    Before initial use, depress pump 4-5 times or until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily, as needed, or until symptoms improve. Adults: Take 3 sprays. Children 2-12: Take 2 sprays.

  • Other Information

    Contains no artificial flavors or artificial colors. No gluten added. The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Tamper resistant for your protection. Use only if safety seal is intact.

  • INACTIVE INGREDIENT

    Citric acid, potassium sorbate, purified water

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

    Temporarily relieves dizziness & nausea

  • INGREDIENTS AND APPEARANCE
    DIZZIFREE 
    bryonia, cocculus, gelsemium, lobelia inf spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_C]  in 59 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]  in 59 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED30 [hp_C]  in 59 mL
    LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA30 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-204-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/15/2016
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350api manufacture(68703-204) , manufacture(68703-204)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!