Umcka Elderberry

Schwabe North America
Human Otc Drug
NDC 53499-1845

Umcka Elderberry is a human otc drug labeled by 'Schwabe North America'. National Drug Code (NDC) number for Umcka Elderberry is 53499-1845. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Umcka Elderberry 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 Sambucus Nigra Flowering Top - 3 [hp_X]/120mL . The currest status of Umcka Elderberry drug is Active.

Drug Information:

Drug NDC:	53499-1845
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 Elderberry
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 Elderberry
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 SAMBUCUS NIGRA FLOWERING TOP - 3 [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:	09 Nov, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 Jun, 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.
UPC:	0033674158456
UPC stands for Universal Product Code.
UNII:	U0NQ8555JD T7J046YI2B S546YLW6E6 1W0775VX6E 639KR60Q1Q 62I3C8233L H6J53HEX8E 27YLU75U4W CT03BSA18U
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
53499-1845-7	1 BOTTLE in 1 BOX (53499-1845-7) / 120 mL in 1 BOTTLE	09 Nov, 2022	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 Elderberry

Syrup
Schwabe North America
NDC: 53499-1845

Umcka Elderberry

Syrup
Schwabe North America
NDC: 53499-9845

Purpose:

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

Product Elements:

Umcka elderberry umcka elderberry pelargonium sidoides root pelargonium sidoides root aconitum napellus aconitum napellus eucalyptus globulus leaf eucalyptus globulus leaf sambucus nigra flowering top sambucus nigra flowering top bryonia alba root bryonia alba root eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top gelsemium sempervirens root gelsemium sempervirens root ipecac ipecac phosphorus phosphorus anhydrous citric acid european elderberry alcohol glycerin lactose monohydrate maltodextrin water sorbitol raspberry and elderberry flavor

Indications and Usage:

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

Warnings:

Warnings sore throat warning : if sore throat is severe or persistent more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, c onsult a doctor promptly.

Dosage and Administration:

Dosage & administration directions for best results, use at first sign of symptoms. continue to use for an additional 48 hours after symptoms cease. use only with enclosed dosage cup. adults & children 13 years of age and older: take 1 1/2 teaspoons (tsp) (7.5 ml) three times daily. children 6 to 12 years of age: take 1 teaspoon (tsp) (5ml) three times daily. children under 6 years of age: consult a doctor.

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, cough lasts more then 7 days or occurs with rash or persistent headache. these could be signs of a serious condition.

Package Label Principal Display Panel:

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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.