Label: BANIFLU- gelsemium, influenzinum, nux vom tablet

  • 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 January 2, 2013

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  • PURPOSE

    Supports protection during cold and flu season

  • ACTIVE INGREDIENT

    Active Ingredients: Each dose contains equal parts of: Gelsemium 30C HPUS, Influenzinum 30C HPUS, Nux vom 30C HPUS.

  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for immune support during cold and flu season.

  • WARNINGS

    Warnings: If symptoms persist or worsen, consult a healthcare professional.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions: Adults: Dissolve 2 tablets in a clean mouth 3 times daily for 7 days prior to the winter season or before traveling. Repeat every 3 months or if exposed to infection. Babies and small children: Take 1/4 of adult serving, crush tablet, and sprinkle onto tongue.

    Special instructions: Avoid strong mint-flavored candy.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Acacia gum, lactose, magnesium stearate, corn starch, sucrose.

  • INFORMATION FOR PATIENTS

    The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

    Distributed by
    Native Remedies, LLC
    6531 Park of Commerce Blvd.
    Suite 160
    Boca Raton, FL 33487
    Phone: +1.877.289.1235
    International: +1.561.999.8857

    Contains no artificial flavors or artificial colors. No gluten added.

  • STORAGE AND HANDLING

    Tamper resistant seal for your protection. Use only if safety seal is intact.

  • PRINCIPAL DISPLAY PANEL

    Bottle label

  • INGREDIENTS AND APPEARANCE
    BANIFLU  
    gelsemium, influenzinum, nux vom tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-035
    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]
    INFLUENZA A VIRUS A/NEW CALEDONIA/20/99 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 3NPZ4Z3B94) (INFLUENZA A VIRUS A/NEW CALEDONIA/20/99 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:I2F6HCP28X) INFLUENZA A VIRUS A/NEW CALEDONIA/20/99 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)30 [hp_C]
    INFLUENZA A VIRUS A/PANAMA/2007/99 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 2UES30W1DF) (INFLUENZA A VIRUS A/PANAMA/2007/99 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:A08BMU572N) INFLUENZA A VIRUS A/PANAMA/2007/99 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)30 [hp_C]
    INFLUENZA B VIRUS B/HONG KONG/330/2001 ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 23CET7LDKD) (INFLUENZA B VIRUS B/HONG KONG/330/2001 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:502XN5489H) INFLUENZA B VIRUS B/HONG KONG/330/2001 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)30 [hp_C]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (White lactose tablets) Scoreno score
    ShapeROUND (Round lactose tablets) Size6mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-035-80180 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/02/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350api manufacture(68703-035) , manufacture(68703-035)
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