UMCKA COLDCARE DAY PLUS NIGHT kit

Umcka ColdCare by

Drug Labeling and Warnings

Umcka ColdCare by is a Homeopathic medication manufactured, distributed, or labeled by ProSolutions Inc., Schwabe North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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INGREDIENTS AND APPEARANCE

UMCKA COLDCARE  DAY PLUS NIGHT
umcka coldcare day plus night kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83102-1060

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83102-1060-1	1 in 1 CARTON	03/01/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	5 g  in 5
Part 2	1 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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)	PELARGONIUM SIDOIDES ROOT	1 [hp_X]  in 5 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	LEMON, CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83102-1040-1	8 in 1 PACKAGE
1		5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2023

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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	2 [hp_X]  in 5 g
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)	PELARGONIUM SIDOIDES ROOT	1 [hp_X]  in 5 g
PASSIFLORA INCARNATA WHOLE (UNII: R48E2W2LMO) (PASSIFLORA INCARNATA WHOLE - UNII:R48E2W2LMO)	PASSIFLORA INCARNATA WHOLE	1 [hp_X]  in 5 g
HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A) (HUMULUS LUPULUS WHOLE - UNII:912A6Q1N4A)	HUMULUS LUPULUS WHOLE	1 [hp_X]  in 5 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83102-1050-1	4 in 1 PACKAGE
1		5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2023

Labeler - ProSolutions Inc. (070769782)

Establishment
Name	Address	ID/FEI	Business Operations
ProSolutions Inc.		070769782	label(83102-1040, 83102-1050, 83102-1060) , pack(83102-1040, 83102-1050, 83102-1060)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(83102-1040, 83102-1050)