UMCKA COLDCARE STARTER KIT kit

Umcka ColdCare Starter Kit by

Drug Labeling and Warnings

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

Drug Details [pdf]

OTC ACTIVE INGREDIENTS:

Cherry Syrup  Pelargonium sidoides 1X

Lemon Packet: Pelargonium sidoides 1X

INACTIVE INGREDIENTS:

Cherry Syrup:  Aronia Juice, Citric Acid, Ethyl Alcohol (0.05%), Fructose, Maltodextrin, Natural Cherry Flavor, Potassium Citrate, Purified Water

Lemon Powder: Citric Acid, Maltodextrin, Silicon Dioxide, natural flavor, Turmeric color, Xylitol

INDICATIONS AND USAGE

Cherry Syrup:  Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, hoarseness, sore throat.

Lemon Powder:  Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, headache, hoarseness, sore throat.

OTC - PURPOSE

Cherry Syrup: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, hoarseness, sore throat.

Lemon Powder: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, headache, hoarseness, sore throat.

WARNINGS 

Cherry Syrup:  Sore Throat Warning:  Severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting, or rash may be serious.

Consult a physician promptly.

Lemon Powder: Sore Throat Warning: Severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting, or rash may be serious.

Consult a physician promptly.

OTC  ASK THE DOCTOR

Cherry Sysrup: Ask the doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema or is accompanied by excessive phlegm (mucus).

Lemon Powder:  Ask the doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema or is accompanied by excessive phlegm (mucus).

STOP USE AND ASK A DOCTOR

Cherry Syrup:  Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within seven days, fever worsens or lasts more than three days, cough lasts more than seven days or occurs with rash or persistent headache.

These could be signs of a serious condition.

Lemon Powder:  Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within seven days, fever worsens or lasts more than three days, cough lasts more than seven days or occurs with rash or persistent headache.

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING

Cherry Syrup:  If pregnant or breast-feeding, ask a healthcare professional before use.

Lemon Powder: If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

Cherry Syrup:  Keep out of reach of children

Lemon Powder:  Keep out of reach of children

OVERDOSE

Cherry Syrup:  In case of overdose, seek medical help or contact a Poison Control Center immediately

Lemon Powder:  In case of overdose, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Cherry Syrup:  For best results, use at first sign of symptoms and continue to use for an adaditional 48 hours after symptoms cease. 

Use only with enclosed dosage cup.

Adults and children 12 years of age and older:  take 1 1/2 teaspoon (tsp) (7.5 mL) three times daily

Chidlren 6 - 11 years of age:  take 1 teaspoon (tsp) (5 mL) three times daily

Children under 6 years of age:  Consult a physician

Lemon Powder:  For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symtoms cease.

Dissolve contents of 1 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.

Adults and chilrden 12 years of age and older:  take 3-4 times daily

Children 6-11 years of age:  take 2-3 times daily

Children under 6 years of age:  consult a physician

15273 UMCKA ColdCare Cherry Syrup 4 oz

15273_A04_UMCKACOLD_Cherry Syrup

12137 UMCKA ColdCare Starter Kit

12137_Umcka_Starter Kit_10

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UMCKA COLDCARE STARTER KIT 
umcka coldcare starter kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-2137

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-2137-1	1 in 1 CARTON	10/09/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	120 mL
Part 2	1 PACKET	5 g

Part 1 of 2

UMCKA COLDCARE ALCOHOL FREE CHERRY 
pelargonium sidoides syrup

Product Information
Item Code (Source)	NDC: 53499-5273
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 240 mL

Inactive Ingredients
Ingredient Name	Strength
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
FRUCTOSE (UNII: 6YSS42VSEV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5273-5	1 in 1 CARTON
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 2 of 2

UMCKA COLDCARE LEMON 
pelargonium sidoides powder

Product Information
Item Code (Source)	NDC: 53499-5146
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TURMERIC (UNII: 856YO1Z64F)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5146-0	10 in 1 CARTON
1		5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/09/2017

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-2137)