Label: HOMEOPATHIC COLD AND FLU FORMULA- aconitium napellus, belladonna, echinacea angustifolia, eupatorium perfoliatum, gelsemium sempervirens, ferrum phosphoricum, influenzinum 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 March 25, 2011

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  • ACTIVE INGREDIENT

    I n g r e d i e n t s :

    Aconite.............................. 6X HPUS
    Deadly nightshade..........................................6X HPUS
    Purple cone flower.........................6X HPUS
    Boneset........................6X HPUS

    Yellow jasmine.....................6X HPUS

    Phosphate of iron...........................8X HPUS

    Influenza virus vaccine........................................200C HPUS


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

  • PURPOSE

    For relief of fever, chills, body aches and pain, congestion and sore throat due to cold and flu

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF
    REACH OF CHILDREN.

  • INDICATIONS & USAGE

    For relief of fever, chills, body aches and pain, congestion and sore throat due to cold and flu
  • WARNINGS

    Warning: If you are taking any medications or
    are pregnant or breast feeding do not use prior to
    consulting a physician.

  • DOSAGE & ADMINISTRATION


    Suggested Use: Adults and children over 12
    years, take 1 tablet every 4 hours, not to exceed 6 tablets per day, or as directed by a health professional.
    Take tablet 15 minutes before or after meals. Dissolve under the tongue or chew. Children under 2 years, consult
    a health care professional. If symptoms persist for more than 3 days or worsen, consult a
    health professional. A persistent sore throat accompanied by a fever, nausea or vomiting maybe a sign of a more
    serious condition.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Dextrose, Magnesium
    Stearate, Silica.

  • PRINCIPAL DISPLAY PANEL

    NDC# 1057803990

    Homeopathic Cold and Flu Formula

    For relief of fever, chills, body aches and pain, congestion and sore throat due to cold and flu

    300 mg.
    90 Tablets



    image of label

  • USER SAFETY WARNINGS

    For your protection, this container has an outer
    safety seal. (Do not accept if missing or broken.)
    Best if used by date on bottle. Store in a dry cool place.
    Any Questions? 1-800-644-8327
    website: www.botanicchoice.com

  • SPL UNCLASSIFIED SECTION

    FDA Establishment #: 1811575

    Distributed by: Indiana Botanic Gardens, Inc.
    3401 W. 37th Ave. Hobart, IN 46342

  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC COLD AND FLU FORMULA 
    aconitium napellus, belladonna, echinacea angustifolia, eupatorium perfoliatum, gelsemium sempervirens, ferrum phosphoricum, influenzinum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-039
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA6 [hp_X]
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM8 [hp_X]
    HAEMOPHILUS INFLUENZAE TYPE B (UNII: F2TW0N64FI) (HAEMOPHILUS INFLUENZAE TYPE B - UNII:F2TW0N64FI) HAEMOPHILUS INFLUENZAE TYPE B200 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code H;367
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-039-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2001
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771label
    Establishment
    NameAddressID/FEIBusiness Operations
    ASI Marketing Group964366611manufacture
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