Label: UMCKA COLDCARE LEMON- pelargonium sidoides powder

  • NDC Code(s): 53499-5146-0
  • Packager: Schwabe North America, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 2, 2023

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  • Active Ingredient

    PELARGONIUM SIDOIDES 1X

    Inactive Ingredients

    citric acid

    maltodextrin

    natural flavor

    silica

    turmeric color

    xylitol

  • Dosage & Administration

    Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.

    May also be dissolved in 4-6 ounces of cold water, which may be preferable for children.

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

    Adults and children 13 years of age and older: Take 3 times daily.

    Children 6-12 years of age: Take 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/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat. 

    Purpose

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

  • Warnings

    Sore throat warning: if sore throat is severe or persistent more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a physician promptly.

  • Ask Doctor

    Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, have a cough that is accompanied by excessive phlegm (mucus), are taking any medications, have an allergey to plants of the Geraniaceae family.

  • Stop Use

    Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cought lasts more than 7 days or occurs with rash or persistent headache.

    These could be signs of a serious condition.

  • Pregnant or breast feeding

    If 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 contact a Poison Control Center immediately. 

  • PRINCIPAL DISPLAY PANEL

    LGBN15146.02-Umcka-Coldcare-Lemon-Hot-Drink-10-ct

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE LEMON  
    pelargonium sidoides powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5146
    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 5 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TURMERIC (UNII: 856YO1Z64F)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (NATURAL LEMON FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5146-010 in 1 CARTON07/01/2009
    15 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2009
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-5146)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProSolutions, Inc.070769782label(53499-5146) , pack(53499-5146)
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