Label: UMCKA COLDCARE DAY PLUS NIGHT kit

  • NDC Code(s): 83102-1040-1, 83102-1050-1, 83102-1060-1
  • Packager: ProSolutions 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 March 1, 2023

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

View All Sections
  • 1040-1

    Active Ingredients panel

  • 1040-1

    Inactive Ingredients panel

  • 1040-1

    Dosage and Administration panel

  • 1040-1

    Indications and Usage

  • 1040-1

    Warnings Panel

  • 1040-1

    Ask Doctor panel

  • 1040-1

    Stop Use panel

  • 1040-1

    Pregnancy Panel

  • 1040-1

    Keep out of reach panel

  • 1040-1

    Over dosage panel

  • 1040-1

    Purpose Panel

  • 1050-1

    Active Ingredients panel

  • 1050-1

    Inactive Ingredients panel

  • 1050-1

    Dosage and Administration panel

  • 1050-1

    Indications and Usage panel

  • 1050-1

    Warnings panel

  • 1050-1

    Ask Doctor panel

  • 1050-1

    Stop use panel

  • 1050-1

    Pregnancy panel

  • 1050-1

    Keep out of reach panel

  • 1050-1

    Over dosage panel

  • 1050-1

    Purpose panel

  • 1060-1

    Primary Panel 1060-1

  • 1040-1

    1040-1 Primary Panel

  • 1050-1

    1050-1 Primary Panel

  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE  DAY PLUS NIGHT
    umcka coldcare day plus night kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83102-1060
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83102-1060-11 in 1 CARTON03/01/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 POUCH 5 g  in 5 
    Part 21 POUCH 5 g  in 5 
    Part 1 of 2
    UMCKA COLDCARE  DAY
    pelargonium sidoides root powder
    Product Information
    Item Code (Source)NDC:83102-1040
    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
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    TURMERIC (UNII: 856YO1Z64F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON, CITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83102-1040-18 in 1 PACKAGE
    15 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2023
    Part 2 of 2
    UMCKA COLDCARE  NIGHT
    pelargonium sidoides root, chamomile, humulus lupulus, passiflora incarnata, powder
    Product Information
    Item Code (Source)NDC:83102-1050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE2 [hp_X]  in 5 g
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 5 g
    PASSIFLORA INCARNATA WHOLE (UNII: R48E2W2LMO) (PASSIFLORA INCARNATA WHOLE - UNII:R48E2W2LMO) PASSIFLORA INCARNATA WHOLE1 [hp_X]  in 5 g
    HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A) (HUMULUS LUPULUS WHOLE - UNII:912A6Q1N4A) HUMULUS LUPULUS WHOLE1 [hp_X]  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    HONEY (UNII: Y9H1V576FH)  
    SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    TURMERIC (UNII: 856YO1Z64F)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83102-1050-14 in 1 PACKAGE
    15 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2023
    Labeler - ProSolutions Inc. (070769782)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProSolutions Inc.070769782label(83102-1040, 83102-1050, 83102-1060) , pack(83102-1040, 83102-1050, 83102-1060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(83102-1040, 83102-1050)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!