Label: UMCKA COLDCARE STARTER KIT kit

  • NDC Code(s): 53499-2137-1, 53499-5146-0, 53499-5273-5
  • 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 December 28, 2018

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

  • OTC ACTIVE INGREDIENTS:

    Cherry Syrup  Pelargonium sidoides 1X

    Lemon Packet: Pelargonium sidoides 1X

    INACTIVE INGREDIENTS:

    Cherry Syrup:  Aronia Juice, Citric Acid, Ethyl Alcohol (0.05%), Fructose, Maltodextrin, Natural Cherry Flavor, Potassium Citrate, Purified Water

    Lemon Powder: Citric Acid, Maltodextrin, Silicon Dioxide, natural flavor, Turmeric color, Xylitol

  • INDICATIONS AND USAGE

    Cherry Syrup:  Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, hoarseness, sore throat.

    Lemon Powder:  Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, headache, hoarseness, sore throat.

  • OTC - PURPOSE

    Cherry Syrup: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, hoarseness, sore throat.


    Lemon Powder: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, headache, hoarseness, sore throat.

  • WARNINGS 

    Cherry Syrup:  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.

    Lemon Powder: 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.

  • OTC  ASK THE DOCTOR

    Cherry Sysrup: Ask the 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).

    Lemon Powder:  Ask the 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

    Cherry Syrup:  Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within seven days, fever worsens or lasts more than three days, cough lasts more than seven days or occurs with rash or persistent headache.

    These could be signs of a serious condition.

    Lemon Powder:  Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within seven days, fever worsens or lasts more than three days, cough lasts more than seven days or occurs with rash or persistent headache.

    These could be signs of a serious condition.

  • OTC - PREGNANCY OR BREAST FEEDING

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

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

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Cherry Syrup:  Keep out of reach of children

    Lemon Powder:  Keep out of reach of children

  • OVERDOSE

    Cherry Syrup:  In case of overdose, seek medical help or contact a Poison Control Center immediately

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

  • DOSAGE & ADMINISTRATION

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

    Use only with enclosed dosage cup.

    Adults and children 12 years of age and older:  take 1 1/2 teaspoon (tsp) (7.5 mL) three times daily

    Chidlren 6 - 11 years of age:  take 1 teaspoon (tsp) (5 mL) three times daily

    Children under 6 years of age:  Consult a physician

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

    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.

    Adults and chilrden 12 years of age and older:  take 3-4 times daily

    Children 6-11 years of age:  take 2-3 times daily

    Children under 6 years of age:  consult a physician

  • 15273 UMCKA ColdCare Cherry Syrup 4 oz

    15273_A04_UMCKACOLD_Cherry Syrup15273_A04_UMCKACOLD_CHERRY SYRUP.jpg15273_A04_UMCKACOLD_CHERRY SYRUP.jpg15273_A04_UMCKACOLD_CHERRY SYRUP.jpg

  • 12137 UMCKA ColdCare Starter Kit

    12137_Umcka_Starter Kit_1012137_Umcka_Starter Kit_10.jpg12137_Umcka_Starter Kit_10.jpg

    12137_Umcka_Starter Kit_10.jpg

  • PRINCIPAL DISPLAY PANEL

    15146_04_UMCKACOLD_LEMON.jpg15146_04_UMCKACOLD_LEMON.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE STARTER KIT 
    umcka coldcare starter kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-2137
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-2137-11 in 1 CARTON10/09/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 120 mL
    Part 21 PACKET 5 g
    Part 1 of 2
    UMCKA COLDCARE ALCOHOL FREE CHERRY 
    pelargonium sidoides syrup
    Product Information
    Item Code (Source)NDC:53499-5273
    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 240 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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5273-51 in 1 CARTON
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic
    Part 2 of 2
    UMCKA COLDCARE LEMON 
    pelargonium sidoides powder
    Product Information
    Item 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
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5146-010 in 1 CARTON
    15 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/09/2017
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-2137)