UMCKA COLDCARE DAY PLUS NIGHT- umcka coldcare day plus night 
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 Day + Night

Active Ingredient

Umcka CC Day: Pelargonium sidoides 1X

Umcka CC Night: Pelargonium sidoides 1X

                         Chamomilla recutila 2X

                        Humulus Lupulus 1X

                        Passiflora incarnate 1X

Inactive Ingredient

Umcka CC Day: Citric acid, maltodextrin, natural flavor, silica, turmeric color, xylitol.
Umcka CC Night: Citric acid, honey, lactose monohydrate, lou han guo, maltodextrin, natural flavor, silica, stevia leaf extract, turmeric color, xylitol.

Doage & Administration

Directions

Umcka CC Day: 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 symptoms cease.

Adults/Children 12 years of age and older: Take 1 packet 2 times daily

Children 6-11 years of age: Take 1 packet 2 times daily

Children under 6 years of age: Consult a doctor

Umcka CC Night: 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 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 years of age: Consult a doctor

Indications & Usage

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

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

Umcka CC Night: 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 Day: Sore throat warning: severe or presistent 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.

Umcka CC Night: Sore throat warning: severe or presistent 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 Day: Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, have a cough that is accompanied by excessive phlegm (mucus), are taking any medications, have any allergy to plants of the Geraniaceae family.

Umcka CC Night: Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, have a cough that is accompanied by excessive phlegm (mucus), are taking any medications, have any allergy to plants of the Geraniaceae family.

Stop Use

Umcka CC Day: 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.

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

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

Keep out of reach of children.

Umcka CC Day: Keep out of reach of children.

Umcka CC Night: Keep out of reach of children.

Overdose

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

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

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UMCKA COLDCARE  DAY PLUS NIGHT
umcka coldcare day plus night kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-1060
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-1060-11 in 1 CARTON12/09/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 5 g
Part 21 POUCH 5 g
Part 1 of 2
UMCKA COLDCARE  DAY
pelargonium sidoides root powder
Product Information
Item Code (Source)NDC:53499-1040
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TURMERIC (UNII: 856YO1Z64F)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON, CITRUSImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-1040-18 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 homeopathic12/09/2015
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 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
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE2 [hp_X]  in 5 g
HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A) ( HUMULUS LUPULUS WHOLE - UNII:912A6Q1N4A) HUMULUS LUPULUS WHOLE1 [hp_X]  in 5 g
PASSIFLORA INCARNATA WHOLE (UNII: R48E2W2LMO) ( PASSIFLORA INCARNATA WHOLE - UNII:R48E2W2LMO) PASSIFLORA INCARNATA WHOLE1 [hp_X]  in 5 g
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
Color    Score    
ShapeSize
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-1050-14 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 homeopathic12/09/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/09/2015
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc.831153908manufacture(53499-1060)
Establishment
NameAddressID/FEIBusiness Operations
ProSolutions, Inc.070769782label(53499-1060) , pack(53499-1060)

Revised: 5/2023
Document Id: 7feac152-de98-4873-880f-68ec18e5a763
Set id: cbf06050-23e1-464c-8aca-f752717c2de1
Version: 11
Effective Time: 20230522
 
Schwabe North America, Inc.