Umcka Coldcare Mint Chewable
Pelargonium Sidoides
Schwabe North America, Inc
Human Otc Drug
NDC 53499-9145Umcka Coldcare Mint Chewable also known as Pelargonium Sidoides is a human otc drug labeled by 'Schwabe North America, Inc'. National Drug Code (NDC) number for Umcka Coldcare Mint Chewable is 53499-9145. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Umcka Coldcare Mint Chewable drug includes Pelargonium Sidoides Root - 1 [hp_X]/1 . The currest status of Umcka Coldcare Mint Chewable drug is Active.
Drug Information:
| Drug NDC: | 53499-9145 |
| 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 Mint Chewable |
| 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: | Pelargonium Sidoides |
| 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: | Tablet, Chewable |
| 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: | PELARGONIUM SIDOIDES ROOT - 1 [hp_X]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 29 Dec, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| 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: | 24 Dec, 2025 |
| 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: | 0033674151457
|
| UPC stands for Universal Product Code. |
| UNII: | H6J53HEX8E
|
| 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 |
|---|
| 53499-9145-0 | 2 BLISTER PACK in 1 CARTON (53499-9145-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK | 29 Dec, 2016 | 31 Dec, 2023 | 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 shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial infections: congestion, cough, hoarseness, sore throat.
Product Elements:
Umcka coldcare mint chewable pelargonium sidoides pelargonium sidoides root pelargonium sidoides root magnesium stearate maltodextrin mannitol croscarmellose sodium menthol sorbitol stearic acid xylitol alcohol natural menthol flavor natural spearmint flavor white tablet c c
Indications and Usage:
Indications & usage shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial infections: congestion, cough, hoarseness, sore throat.
Warnings:
Warnings sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a high fever, headache, nausea, vomiting or rash may be serious. consult physician promptly. ask doctor ask a doctor before use if you have a persistent or chronic cough thats lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or is accompanied by excessive phlegm (mucus). stop use stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 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 if pregnant or breast-feeding, ask a healthcare professional before use. keep out reach of children keep out reach of children overdose in case of overdose, seek medical help or contact a poison control center immediately.
Dosage and Administration:
Dosage & administration chew or dissolve tablets in the mouth. do not swallow whole. for best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. adults and children 12 years of age and older : take 1 chewable tablet three times daily. children 6-11 years of age : take 1 chewable tablet two times daily. children under 6 years of age: consult a physician. indications & usage shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial infections: congestion, cough, hoarseness, sore throat. purpose shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial infections: congestion, cough, hoarseness, sore throat.
Stop Use:
Stop use stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 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 in case of overdose, seek medical help or contact a poison control center immediately.
Package Label Principal Display Panel:
15145-umcka cc mint-6.jpg