Umcka Coldcare Starter Kit
Schwabe North America, Inc.
Human Otc Drug
NDC 53499-2137Umcka Coldcare Starter Kit is a human otc drug labeled by 'Schwabe North America, Inc.'. National Drug Code (NDC) number for Umcka Coldcare Starter Kit is 53499-2137. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Umcka Coldcare Starter Kit drug includes . The currest status of Umcka Coldcare Starter Kit drug is Active.
Drug Information:
| Drug NDC: | 53499-2137 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Umcka Coldcare Starter Kit |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Umcka Coldcare Starter Kit |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Schwabe North America, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 09 Oct, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Schwabe North America, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0033674151464
0033674152737
0033674121375
|
| UPC stands for Universal Product Code. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53499-2137-1 | 1 KIT in 1 CARTON (53499-2137-1) * 1 BOTTLE, PLASTIC in 1 CARTON (53499-5273-5) / 120 mL in 1 BOTTLE, PLASTIC * 10 PACKET in 1 CARTON (53499-5146-0) / 5 g in 1 PACKET | 09 Oct, 2017 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
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.
Product Elements:
Umcka coldcare starter kit umcka coldcare starter kit umcka coldcare alcohol free cherry pelargonium sidoides pelargonium sidoides root pelargonium sidoides root aronia melanocarpa fruit juice anhydrous citric acid alcohol fructose maltodextrin potassium citrate water umcka coldcare lemon pelargonium sidoides pelargonium sidoides root pelargonium sidoides root anhydrous citric acid maltodextrin silicon dioxide turmeric xylitol
Indications and Usage:
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.
Warnings:
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.
Dosage and Administration:
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: ttke 2-3 times daily children under 6 years of age: consult a physician
Stop Use:
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.
Overdosage:
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.
Package Label Principal Display Panel:
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