UMCKA ORIGINAL COLDCARE (PELARGONIUM SIDOIDES) LIQUID [SCHWABE NORTH AMERICA]

UMCKA ORIGINAL COLDCARE (PELARGONIUM SIDOIDES) LIQUID [SCHWABE NORTH AMERICA]
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NDC 53499-5270-4, 53499-5270-8
Set ID 3760dfe0-fecd-40c3-95bf-76f0b08d8686
Category HUMAN OTC DRUG LABEL
Packager Schwabe North America
Generic Name
Product Class
Product Number
Application Number
  • 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 and children 12 years of age and older: Take 1.5 mL three times daily by mouth.

    Children under 12 years of age: Consult a physician.

  • Indications & Usage

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

  • Purpose

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

  • Warnings

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

    Consult a physician promptly.

  • Ask Doctor

    Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema, or is cough 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, 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, consult 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 immediately.

  • PRINCIPAL DISPLAY PANEL

    15270-Umcka Original Liquid_A01.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA ORIGINAL COLDCARE  
    pelargonium sidoides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5270
    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:53499-5270-41 in 1 CARTON02/02/2009
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:53499-5270-81 in 1 CARTON02/02/2009
    260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/02/2009
    Labeler - Schwabe North America (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc831153908manufacture(53499-5270)

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