Label: UMCKA ORIGINAL COLDCARE- pelargonium sidoides liquid

  • NDC Code(s): 53499-6270-4, 53499-6270-8
  • Packager: Schwabe North America
  • 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 April 6, 2023

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

  • Active Ingredient

    PELARGONIUM SIDOIDES 1X

  • Inactive Ingredient

    ethyl alcohol
    glycerin
    maltodextrin
    purified water

  • Dosage & Administation

    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 12 years of age and under: consult a physician before use.

  • 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.

  • Overdosage

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

  • PRINCIPAL DISPLAY PANEL

    LGBN15270.A02-Umcka-Original-Liquid-1-oz.jpg

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  • INGREDIENTS AND APPEARANCE
    UMCKA ORIGINAL COLDCARE  
    pelargonium sidoides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-6270
    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 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-6270-41 in 1 CARTON04/06/2023
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:53499-6270-81 in 1 CARTON04/06/2023
    259.1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/06/2023
    Labeler - Schwabe North America (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc831153908manufacture(53499-6270)