Label: PRUNUS SPINOSA globule

  • 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 May 1, 2023

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  • ACTIVE INGREDIENT

    Prunus Spinosa 6X, HPUS

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

  • PURPOSE

    Use as a refreshing, restoring tonic. Especially with exhaustion. May also be used for standard homeopathic indications or as directed by your physician.

  • Use:

    Use as a refreshing, restoring tonic. Especially with exhaustion. May also be used for standard homeopathic indications or as directed by your physician.

  • Warnings:

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • DO NOT USE

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

  • 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.

  • Other Ingredients:

    Sucrose

  • QUESTIONS

    Developed and Made by

    True Botanica, LLC

    1005 Richards Rd., Suite D

    Hartland, WI 53029

    800-315-8783

    www.truebotanica.com

  • Principal Display Panel

    Prunus Spinosa 6X

  • INGREDIENTS AND APPEARANCE
    PRUNUS SPINOSA 
    prunus spinosa globule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53645-1550
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W) PRUNUS SPINOSA FLOWER BUD6 [hp_X]  in 23 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53645-1550-223 g in 1 BOTTLE; Type 0: Not a Combination Product02/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/03/2014
    Labeler - True Botanica, LLC (182071519)
    Establishment
    NameAddressID/FEIBusiness Operations
    True Botanica, LLC182071519manufacture(53645-1550)
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