Umcka Cold Flu Berry

Aconitum Napellus, Bryonia Alba, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Pelargonium Sidoides, Phosphorus

Schwabe North America
Human Otc Drug
NDC 53499-9148

Umcka Cold Flu Berry also known as Aconitum Napellus, Bryonia Alba, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Pelargonium Sidoides, Phosphorus is a human otc drug labeled by 'Schwabe North America'. National Drug Code (NDC) number for Umcka Cold Flu Berry is 53499-9148. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Umcka Cold Flu Berry drug includes Aconitum Napellus - 4 [hp_X]/120mL Bryonia Alba Root - 4 [hp_X]/120mL Eucalyptus Globulus Leaf - 2 [hp_X]/120mL Eupatorium Perfoliatum Flowering Top - 6 [hp_X]/120mL Gelsemium Sempervirens Root - 4 [hp_X]/120mL Ipecac - 3 [hp_X]/120mL Pelargonium Sidoides Root - 1 [hp_X]/120mL Phosphorus - 6 [hp_X]/120mL . The currest status of Umcka Cold Flu Berry drug is Active.

Drug Information:

Drug NDC:	53499-9148
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 Cold Flu Berry
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:	Aconitum Napellus, Bryonia Alba, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Pelargonium Sidoides, Phosphorus
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Schwabe North America
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Syrup
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:	ACONITUM NAPELLUS - 4 [hp_X]/120mL BRYONIA ALBA ROOT - 4 [hp_X]/120mL EUCALYPTUS GLOBULUS LEAF - 2 [hp_X]/120mL EUPATORIUM PERFOLIATUM FLOWERING TOP - 6 [hp_X]/120mL GELSEMIUM SEMPERVIRENS ROOT - 4 [hp_X]/120mL IPECAC - 3 [hp_X]/120mL PELARGONIUM SIDOIDES ROOT - 1 [hp_X]/120mL PHOSPHORUS - 6 [hp_X]/120mL
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:	01 Jan, 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
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.
UNII:	U0NQ8555JD T7J046YI2B S546YLW6E6 1W0775VX6E 639KR60Q1Q 62I3C8233L H6J53HEX8E 27YLU75U4W
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
53499-9148-5	1 BOTTLE, PLASTIC in 1 CARTON (53499-9148-5) / 120 mL in 1 BOTTLE, PLASTIC	01 Jul, 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.

Other medicines with the same generic name

Umcka Cold Flu Berry

Aconitum Napellus & more..

Syrup
Schwabe North America
NDC: 53499-9148

Purpose:

Purpose shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny nose.

Product Elements:

Umcka cold flu berry aconitum napellus, bryonia alba, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, pelargonium sidoides, phosphorus pelargonium sidoides root pelargonium sidoides root aconitum napellus aconitum napellus eucalyptus globulus leaf eucalyptus globulus leaf bryonia alba root bryonia alba root eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top gelsemium sempervirens root gelsemium sempervirens root phosphorus phosphorus ipecac ipecac aronia melanocarpa fruit juice citric acid monohydrate alcohol glycerin lactose monohydrate maltodextrin water sorbitol potassium sorbate natural berry flavor

Indications and Usage:

Indications & usage shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny nose.

Warnings:

Warnings sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied or followed by a high fever, headache, nausea, vomiting, or rash may be serious. consult a physician promptly.

Dosage and Administration:

Dosage & administration directions 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) three times daily. children 6 to 11 years of age: take 1 teaspoon (5 ml) two times daily. children under 6 years of age: consult a physician.

Stop Use:

Stop use 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, or 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:

Add image transcription here... 15148_b01 umcka cold & flu berry syrup.jpg

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.