Label: UMCKA COLDCARE DAY PLUS NIGHT kit
- NDC Code(s): 53499-1040-1, 53499-1050-1, 53499-1060-1
- Packager: Schwabe North America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated May 22, 2023
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- Active Ingredient
- Inactive Ingredient
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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
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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
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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
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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.
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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.
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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
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UMCKA COLDCARE DAY PLUS NIGHT
umcka coldcare day plus night kitProduct 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 powderProduct 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) 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 powderProduct 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) 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) Establishment Name Address ID/FEI Business Operations ProSolutions, Inc. 070769782 label(53499-1060) , pack(53499-1060)
