UMCKA COLDCARE STARTER KIT- umcka coldcare starter kit 
Schwabe North America, 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 Starter Kit

Active Ingredient

Umcka CC Cherry Syrup: Pelargonium sidoides 1X

Soothing Hot Drink-Lemon Packet: Pelargonium sidoides 1X

Inactive Ingredients

Umcka CC Cherry Syrup: aronia juice, citric acid, ethyl alcohol, fructose, glycerin, maltodextrin, natural flavors, potassium sorbate, purified water

Soothing Hot Drink-Lemon Packet:citric acid, maltodextrin, natural flavor, silica, turmeric (color), xylitol

Indications & Usage 

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

Soothing Hot Drink-Lemon Packet: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.

Purpose

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

Soothing Hot Drink-Lemon Packet: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.

Warnings

Umcka CC 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.

Soothing Hot Drink-Lemon Packet: 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.

Ask Doctor

Umcka CC Cherry Syrup: Ask a 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).

Soothing Hot Drink-Lemon Packet:  Ask a 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

Umcka CC Cherry Syrup: Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

Soothing Hot Drink-Lemon Packet:Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

Pregnancy or Breast Feeding

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

Soothing Hot Drink-Lemon Packet: If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of Reach of Children

Umcka CC Cherry Syrup:  Keep out of reach of children.

Soothing Hot Drink-Lemon Packet:  Keep out of reach of children.

Overdose

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

Soothing Hot Drink-Lemon Packet:  In case of overdose, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

Umcka CC Cherry Syrup: 

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

Use only with enclosed dosage cup.

Adults & children 12 years of age and older:  Take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily

Chidlren 6 - 11 years of age:  Take 1 teaspoon (5 mL) 3 times daily

Children under 6 years of age:  Consult a physician

Soothing Hot Drink-Lemon Packet:

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.

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

Adults & 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

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UMCKA COLDCARE STARTER KIT 
umcka coldcare starter kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-2137
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-2137-11 in 1 CARTON10/09/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 120 mL
Part 21 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 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 240 mL
Inactive Ingredients
Ingredient NameStrength
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ALCOHOL (UNII: 3K9958V90M)  
FRUCTOSE (UNII: 6YSS42VSEV)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5273-51 in 1 CARTON
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 2 of 2
UMCKA COLDCARE LEMON 
pelargonium sidoides powder
Product Information
Item Code (Source)NDC:53499-5146
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TURMERIC (UNII: 856YO1Z64F)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5146-010 in 1 CARTON
15 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/09/2017
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc.831153908manufacture(53499-2137)

Revised: 12/2023
Document Id: 1d79a925-232e-4d88-bd1e-0f07712def68
Set id: c267c869-631e-44e4-8cbe-a4da5f305ace
Version: 9
Effective Time: 20231201
 
Schwabe North America, Inc.