Label: UMCKA COLDCARE DAY PLUS NIGHT kit

  • NDC Code(s): 53499-1060-1
  • 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 20, 2018

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

  • OTC Active Ingredients:

    DAY:  Pelargonium sidoides 1X

    NIGHT: Pelargonium sidoides 1X

                Chamomilla recutila 2X

                Humulus Lupulus 1X

                Passiflora incarnate 1X

    Inactive Ingredients:

    DAY:  Citric acid, ethyl alcohol, maltodextrin, natural flavors, silica, turmeric color, xylitol.

    NIGHT: Citric acid, ethyl alcohol, honey, lactose monohydrate, lou han guo (Siraitia grosvenorii fruit), maltodextrin, natural flavor, silica, stevia leaf extract, turmeric color, xylitol.

  • Dosage and Administration

    DAY:  Dissolve contents of one 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 symptoms cease.

    ADULTS/CHILDREN 12 years of age and older:  Take 1 paket 2 times daily

    CHILDREN 6-11 years of age:   Take 1 packet 2 times daily

    CHILDREN UNDER 6:  consult a physician

    8 Packets per carton

    NIGHT: Dissolve contents of one 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 symptoms cease.

    ADULTS/CHILDREN 12 years of age and older: Take 1 packet 30 minutes prior to bedtime

    CHILDREN 6-11 years of age: Take 1/2 packet 30 minutes prior to bedtime

    CHILDREN UNDER 6: Consult a physician

    4 Packets per carton

    Indications and Usage

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

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

    OTC- Purpose

    DAY:  Shortens duration and reduces severity of cough, congestion and sore throat.

    NIGHT:  Shortens duration and reduces severity of cough, congestion, and sore throat.

  • Day: Sore thoart warning: severe or presistent sore throat for than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serious. Consult a physician promptly. Night: Sore thoart warning: severe or presistent sore throat for than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serious.Consult a physician promptly.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Umcka Day Plus Night Carton label

    10601 Umcka Coldcare Day night drink10601 Umcka CC Day Night drink.jpg

  • Umcka Coldcare Day packet label8 packets per carton

    10601 Umcka Coldcare Day packet10601 Umcka Coldcare Day packet.jpg

  • 10601 UMCKA COLDCARE NIGHT4 packets per carton

    10601 Umcka Coldcare night packet10601 Umcka Coldcare Night packet.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE  DAY PLUS NIGHT
    umcka coldcare day plus night kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-1060
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-1060-11 in 1 CARTON12/09/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 POUCH 5 g
    Part 21 POUCH 5 g
    Part 1 of 2
    UMCKA COLDCARE  DAY
    pelargonium sidoides root powder
    Product Information
    Item Code (Source)NDC:53499-1040
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TURMERIC (UNII: 856YO1Z64F)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON, CITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/09/2015
    Part 2 of 2
    UMCKA COLDCARE  NIGHT
    pelargonium sidoides root, chamomile, humulus lupulus whole, passiflora incarnata whole powder
    Product Information
    Item Code (Source)NDC:53499-1050
    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
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE2 [hp_X]  in 5 g
    HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A) ( HUMULUS LUPULUS WHOLE - UNII:912A6Q1N4A) HUMULUS LUPULUS WHOLE1 [hp_X]  in 5 g
    PASSIFLORA INCARNATA WHOLE (UNII: R48E2W2LMO) ( PASSIFLORA INCARNATA WHOLE - UNII:R48E2W2LMO) PASSIFLORA INCARNATA WHOLE1 [hp_X]  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HONEY (UNII: Y9H1V576FH)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    TURMERIC (UNII: 856YO1Z64F)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/09/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/09/2015
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-1060)