Label: UMCKA COLDCARE STARTER KIT kit
- NDC Code(s): 53499-2137-1, 53499-5146-0, 53499-5273-5
- 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 December 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
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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.
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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.
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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.
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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).
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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
- Keep out of Reach of Children
- Overdose
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UMCKA COLDCARE STARTER KIT
umcka coldcare starter kit kitProduct 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 syrupProduct 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 SORBATE (UNII: 1VPU26JZZ4) 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 powderProduct 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)
