Label: BORAX- sodium borate 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 June 11, 2015

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

  • ACTIVE INGREDIENT

    Active Ingredients

    BORAX 200K GR

    BORAX 30CH GR

    BORAX 30K GR

    BORAX 5CH GR

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  • PURPOSE

    Indications

    For the temporary relief of motion sickness, nausea,
    and diarrhea

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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 motion sickness, nausea,
    and diarrhea

    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

    62106-4925

    UNDA
    Do not use if label perforation is broken
    Homeopathic Remedy
    NDC : 62106-4925-4
    BORAX
    Sodium borate
    140 granules
    Indications

    For the temporary relief of motion sickness, nausea,
    and diarrhea

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  • INGREDIENTS AND APPEARANCE
    BORAX 
    sodium borate granule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-4925
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62106-4925-4 10 in 1 CARTON
    1 140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/11/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    Name Address ID/FEI Business Operations
    Unda SA 400346069 manufacture(62106-4925)
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