Label: IODIUM- iodine granule

  • 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, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient

    IODIUM 200K GR

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  • PURPOSE

    Indications

    For the temporary relief of difficulty breathing,
    cough, general weakness, and ravenous hunger

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  • WARNINGS

    Warning:
    If pregnant or breastfeeding, ask a health professional before use.
    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • OVERDOSAGE

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

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  • INACTIVE INGREDIENT

    Inactive Ingredients
    Lactose,
    sucrose.

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  • DOSAGE & ADMINISTRATION

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

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  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

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  • INDICATIONS & USAGE

    Indications

    For the temporary relief of difficulty breathing,
    cough, general weakness, and ravenous hunger

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

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  • PRINCIPAL DISPLAY PANEL

    62106-5070

    UNDA
    Do not use if label perforation is broken
    Homeopathic Remedy
    NDC : 62106-5070-4
    IODIUM
    Iodine
    140 granules
    Indications

    For the temporary relief of difficulty breathing,
    cough, general weakness, and ravenous hunger

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  • INGREDIENTS AND APPEARANCE
    IODIUM 
    iodine granule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-5070
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62106-5070-4 10 in 1 CARTON
    1 140 in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/25/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    Name Address ID/FEI Business Operations
    Unda SA 400346069 manufacture(62106-5070)
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