Label: UMCKA FASTACTIVES CHERRY- pelargonium sidoides powder

  • 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 February 24, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

  • Inactive Ingredients

    Inactive Ingredients panel

  • Dosage & Administration

    Dosage and Administration panel

  • Indications and Usage panel

    Indications and Usage panel

  • Warnings panel

    Warnings panel

  • Ask a Doctor panel

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  • Stop Use panel

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  • Pregnancy or Breast Feeding panel

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  • Keep out of reach of children.

    Keep out of reach of children.

  • Over dosage

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  • INGREDIENTS AND APPEARANCE
    UMCKA FASTACTIVES CHERRY 
    pelargonium sidoides powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83102-1166
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 700 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALIC ACID (UNII: 817L1N4CKP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Natural Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83102-1166-010 in 1 CARTON02/24/2023
    1700 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2023
    Labeler - ProSolutions Inc. (070769782)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProSolutions Inc.070769782label(83102-1166) , pack(83102-1166)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(83102-1166)