UMCKA COLDCARE STARTER KIT KIT [SCHWABE NORTH AMERICA, INC.]

UMCKA COLDCARE STARTER KIT KIT [SCHWABE NORTH AMERICA, INC.]
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NDC 53499-2137-1, 53499-5146-0, 53499-5273-5
Set ID c267c869-631e-44e4-8cbe-a4da5f305ace
Category HUMAN OTC DRUG LABEL
Packager Schwabe North America, Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENTS

    Cherry Syrup  Pelargonium sidoides 1X

    Lemon Packet: Pelargonium sidoides 1X

    INACTIVE INGREDIENTS

    Cherry Syrup:  Aronia Juice, Citric Acid, Ethyl Alcohol, Fructose, Maltodextrin, Natural Flavors, Potassium Citrate, Purified Water

    Lemon Powder: Citric Acid, Maltodextrin, Natural flavor, Silica, Turmeric (color), Xylitol

  • INDICATIONS & USAGE

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

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

  • PURPOSE

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


    Lemon Powder: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: 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.

  • ASK DOCTOR

    Cherry Syrup: 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).

    Lemon Powder:  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 

    Cherry Syrup:  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.

    Lemon Powder:  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

    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.

  • 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) 3 times daily

    Chidlren 6 - 11 years of age:  take 1 teaspoon (tsp) (5 mL) 3 times daily

    Children under 6 years of age:  Consult a physician

    Lemon Powder:

    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.

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

    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

  • PRINCIPAL DISPLAY PANEL

    12137_Umcka_Starter Kit_10.jpg

  • PRINCIPAL DISPLAY PANEL

    15146_04_UMCKACOLD_LEMON.jpg

  • PRINCIPAL DISPLAY PANEL

    15273_A04_UMCKACOLD_CHERRY SYRUP.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, PLASTIC 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, PLASTIC; 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)

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