NDC 53499-0159 Umcka Cold Flu Berry Chewable

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

NDC Product Code 53499-0159

NDC CODE: 53499-0159

Proprietary Name: Umcka Cold Flu Berry Chewable What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Pelargonium Sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
PINK (C48328 - PINK WITH PINKISH-PURPLE SPECKS)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
C
Flavor(s):
BERRY (C73365 - NATURAL BERRY FLAVOR)

NDC Code Structure

  • 53499 - Schwabe North America, Inc.

NDC 53499-0159-0

Package Description: 2 BLISTER PACK in 1 CARTON > 10 TABLET, CHEWABLE in 1 BLISTER PACK

NDC Product Information

Umcka Cold Flu Berry Chewable with NDC 53499-0159 is a a human over the counter drug product labeled by Schwabe North America, Inc.. The generic name of Umcka Cold Flu Berry Chewable is pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Schwabe North America, Inc.

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Umcka Cold Flu Berry Chewable Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PELARGONIUM SIDOIDES ROOT 1 [hp_X]/1
  • ACONITUM NAPELLUS 4 [hp_X]/1
  • BRYONIA ALBA ROOT 4 [hp_X]/1
  • EUCALYPTUS GLOBULUS LEAF 2 [hp_X]/1
  • EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]/1
  • GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X]/1
  • IPECAC 3 [hp_X]/1
  • PHOSPHORUS 6 [hp_X]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANNATTO (UNII: 6PQP1V1B6O)
  • BEET JUICE (UNII: IOZ32L9H3O)
  • CARAMEL (UNII: T9D99G2B1R)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALIC ACID (UNII: 817L1N4CKP)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MANNITOL (UNII: 3OWL53L36A)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • SORBITOL (UNII: 506T60A25R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • XYLITOL (UNII: VCQ006KQ1E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Schwabe North America, Inc.
Labeler Code: 53499
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-21-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Umcka Cold Flu Berry Chewable Product Label Images

Umcka Cold Flu Berry Chewable Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Umcka Cold+ Flu Chewable Berry Tablets

Active Ingredient:PELARGONIUM SIDOIDES 1XACONITUM NAPELLUS 4XBRYONIA 4XEUCALYPTUS GLOBULUS 2XEUPATORIUM PERFOLIATUM 6XGELSEMIUM SEMPERVIRENS 4XIPECACUANHA 3XPHOSPHORUS 6X

Inactive Ingredient

Inactive Ingredients:ANNATTOBEET JUICELACTOSE MONOHYDRATECARAMEL COLORMAGNESIUM STEARATEMALIC ACIDMALTODEXTRINMANNiTOLSODIUM CROSCARMELLOSENATURAL BERRY FLAVORSORBITOLSTEARIC ACIDXYLITOL

Dosage & Administration

Dosage and Administration:Nature's Way Brand:Directions: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 4-5 times daily. Children 6-11 years of age: take 1 chewable tablet 2-4 times daily. Children under 6 years of age: consult a doctor.

Indications & Usage

Indications and Usage:Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat.

Otc - Purpose

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

Warnings

Warnings: Sore throat warning: Severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting or rash may be serious.Consult a physician promptly.Ask a doctor before use if you have: 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).Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of Reach of Children:Keep out of reach of children.

Otc - Ask Doctor

Ask the Doctor:Ask a doctor before use if you have: 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).Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

Pregnancy or Breast Feeding:If pregnant or breast-feeding, ask a healthcare professional before use.

Umcka Cold + Flu Chewable Tablets15159  20 Tablets

15159_A01_UMCKA Berry Cold plus Flu 20 Chewable tablets

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