UMCKA FASTACTIVES CHERRY (PELARGONIUM SIDOIDES) POWDER [SCHWABE NORTH AMERICA, INC.]

UMCKA FASTACTIVES CHERRY (PELARGONIUM SIDOIDES) POWDER [SCHWABE NORTH AMERICA, INC.]
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NDC 53499-1166-0
Set ID 2b3aa577-60b0-4855-ad94-312a6ca0677c
Category HUMAN OTC DRUG LABEL
Packager Schwabe North America, Inc.
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredient

    PELARGONIUM SIDOIDES  1X

    Inactive Ingredients

    CITRIC ACID

    MALIC ACID

    MALTODEXTRIN

    NATURAL FLAVOR

    SILICA

     XYLITOL

  • Dosage & Administration

    Tear packet open, pour contents into mouth and swallow.

    For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

    Adults and children 12 years of age and older: take contents of 1 packet 3 times daily.
    Children 6-11 years of age: take contents of 1 packet 2 times daily.
    Children under 6 years of age: consult a physician.

    Indications & Usage

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial irritations: congestion, cough,  hoarseness, sore throat.  

    Purpose

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial irritations: congestion, cough, hoarseness, sore throat.

  • Warning

    Sore throat warning: severe or persistent sore throat for more than 2 days of if accompanied by high fever, headache, nausea, vomiting or rash may be serious.

    Consult a physician pomptly.

  • Ask Doctor

    Ask a doctor before use if you have a peristent or chronic cought that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or is accompanied by excessive phlegm (mucus)

  • Stop Use

    Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, ever worsens or lasts more than 3 days,  cough lasts more than 7 days or occurs with a rash or persistent headache. These could be signs of a serious condition. 

  • Pregnant or breast feeding

    If you are pregnant or breast-feeding, ask a healthcare professional before use.

  • Keep out of reach of children

    Keep out of reach of children.

  • Overdose

    In case of overdose, seek medical help or contract a Posion Control Center immediatley. 

  • PRINCIPAL DISPLAY PANEL

    Umcka 60166 CC Fastactives Cherry.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA FASTACTIVES CHERRY 
    pelargonium sidoides powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-1166
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (NATURAL CHERRY FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-1166-010 in 1 CARTON07/03/2018
    1700 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/03/2018
    Labeler - Schwabe North America, Inc. (831153908)
    Registrant - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-1166)

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