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 Schwabe North America, Inc., ProSolutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Umcka Coldcare Day packet label8 packets per carton

10601 UMCKA COLDCARE NIGHT4 packets per carton

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: 53499-1060

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-1060-1	1 in 1 CARTON	12/09/2015

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

Part 1 of 2

UMCKA COLDCARE  DAY
pelargonium sidoides root powder

Product Information
Item Code (Source)	NDC: 53499-1040
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
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
Shape		Size
Flavor	LEMON, CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-1040-1	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		12/09/2015

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 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
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	2 [hp_X]  in 5 g
HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A) ( HUMULUS LUPULUS WHOLE - UNII:912A6Q1N4A)	HUMULUS LUPULUS WHOLE	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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-1050-1	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		12/09/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/09/2015

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-1060)