Label: UMCKA COLDCARE CHILDRENS CHERRY- pelargonium sidoides syrup

  • NDC Code(s): 53499-0165-5
  • 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 November 14, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredient:

    PELARGONIUM SIDOIDES 1X

    Inactive Ingredients:

    ARONIA  JUICE

    CITRIC ACID

    ALCOHOL (0.05%)

    FRUCTOSE

    MALTODEXTRIN

    NATURAL CHERRY FLAVOR

    POTASSIUM CITRATE

    PURIFIED WATER

    POTASSIUM SORBATE

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:

    Nature's Way Brand:

    Directions:

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

    Use only with enclosed dosage cup.

    Children 12 years of age and older: Take 1.5 teaspoons (7.5mL) three times daily.
    Children 6-11 years of age: Take 1 teaspoon (5mL) three times daily.
    Children under 6 years of age: Ask a physician.

    Indications and 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

    Warnings: 

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

    Consult a physician promptly.

    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 accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better in 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.

    Keep Out of Reach of Children:

    Keep out of the reach of children.

    Ask the Doctor:

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

    Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better in 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

    Pregnancy or Breast Feeding:

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

    Overdosage:

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

  • PRINCIPAL DISPLAY PANEL

    60165-Umcka CC Children's Cherry Syrup_B01.jpg60165-Umcka CC Children's Cherry Syrup_B01.jpg

    60165-Umcka CC Children's Cherry Syrup_B01.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE CHILDRENS CHERRY 
    pelargonium sidoides syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0165
    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 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (NATURAL CHERRY FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-0165-51 in 1 CARTON09/01/2009
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc831153908manufacture(53499-0165)