UMCKA THROAT (PELARGONIUM SIDOIDES ROOT) SPRAY [SCHWABE NORTH AMERICA, INC]

UMCKA THROAT (PELARGONIUM SIDOIDES ROOT) SPRAY [SCHWABE NORTH AMERICA, INC]
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NDC 53499-0533-2
Set ID 80741b0e-51b0-4523-a4d0-4f2b91a6fbca
Category HUMAN OTC DRUG LABEL
Packager Schwabe North America, Inc
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredient

    Pelargonium Sidoides Root 1X

  • Inactive Ingredient

    Ethyl Alcohol 8.5%

    Glycerin

    Maltodextrin

    Menthol

    Natural Flavor

    Purified Water

    Xylitol 

  • Purpose

    Shortens duration and reduces severity of symptons associated with a sore throat.

  • Indications & Usage

    Shortens duration and reduces severity of symptons associated with a sore throat.

  • Dosage & Administration

    Directions:

    Shake well before use.

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

    Adults & children 12 years of age and older: apply 4 sprays into the back of the mouth 3 times daily.

    Children under 12 years of age: consult a physician

  • Warning

    Sore Throat warning: severe or persistent more than 2 days or if accompanied by a high fever, headache, nausea, vomiting, or rash maybe serious.

    Consult a physician promptly.

  • Ask Doctor

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

  • Stop Use

    Stop use and ask a doctor if new symptoms occur, symptoms get worse, lasts more than 7 days, or fever worsens or lasts more than 3 days.
    These could be signs of a serious condition

  • Pregnancy or Breast Feeding

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

  • Keep out of reach of children.

    Keeo out of reach of children.

  • Overdoseage

    In case of overdose, seek medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    10533-Umcka Throat Spray_1.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA THROAT 
    pelargonium sidoides root spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0533
    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 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    MENTHOL (UNII: L7T10EIP3A)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    CHERRY JUICE (UNII: 4XTQ10247Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINT, CHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-0533-21 in 1 BOX09/01/201412/31/2021
    159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/201412/31/2021
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-0533)

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