Label: PLUMBUM MEL.- lead globule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/13

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

  • ACTIVE INGREDIENT

    Plumbum Mel. 30X, HPUS

    The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

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  • PURPOSE

    Enter section text here

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  • Use:

    For temporary relief of dizziness.  Supports aging memory.  May also be used for standard homeopathic indications or as directed by your physician.

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  • Warnings:

    Consult your health care provider if symptoms persist more than 5 days or worsen.

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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 the reach of children.

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  • DO NOT USE

    TAMPER EVIDENT: Do not use if safety seal is broken before first use.

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  • Directions for Use:

    Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3
     globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

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  • Other Ingredients:

    Sucrose

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  • QUESTIONS



    Developed and Made by

    True Botanica, LLC

    1005 Richards Rd., Suite D

    Hartland, WI 53029

    800-315-8783

    www.truebotanica.com

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    PLUMBUM MEL. 
    plumbum mel. globule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53645-1250
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEAD (LEAD) LEAD 30 [hp_X]  in 23 g
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 4mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53645-1250-2 23 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/21/2013
    Labeler - True Botanica, LLC (182071519)
    Establishment
    Name Address ID/FEI Business Operations
    True Botanica, LLC 182071519 manufacture(53645-1250)
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