UMCKA COLDCARE DAY PLUS NIGHT- umcka coldcare day plus night 
ProSolutions Inc.

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.

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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)

Revised: 3/2023
Document Id: f5d9ec67-6772-653d-e053-2995a90a75c3
Set id: f5d9ec67-6771-653d-e053-2995a90a75c3
Version: 1
Effective Time: 20230301
 
ProSolutions Inc.