Label: UMCKA COLDCARE ALCOHOL-FREE- pelargonium sidoides liquid

  • NDC Code(s): 53499-6271-8
  • Packager: Schwabe North America, Inc.
  • 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 October 25, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient

    PELARGONIUM SIDOIDES 1x

  • Inactive Ingredient

    citric acid

    ethyl alcohol

    glycerin

    maltodextrin

    potassium sorbate

    purified water

    sorbitol

  • Dosage & Administration

    Directions:

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

    Adults & children 13 years of age and older: Take 1.5 mL three times daily by mouth.

    Children 6-12 years of age: Take 1 mL three times daily by mouth.

    Children 1-5 years of age: Take 0.5 mL three times daily by mouth.

  • 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, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor 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, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy 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, cough lasts more than 7 days or occurs with rash or persistent headache.

    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.

    Keep out of reach of children.

  • Overdose

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

  • PRINCIPAL DISPLAY PANEL

    LGBN15791.B03 Umcka Orig 99.9 Alcoh-Free Liq 2oz.jpg

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  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE ALCOHOL-FREE 
    pelargonium sidoides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-6271
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-6271-81 in 1 CARTON03/21/202302/28/2027
    159 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/21/202302/28/2027
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-6271)