Vclear Berry Dissolving Tablets
Pelargonium Sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus
Schwabe North America, Inc.
Human Otc Drug
NDC 59800-3656Vclear Berry Dissolving Tablets also known as Pelargonium Sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus is a human otc drug labeled by 'Schwabe North America, Inc.'. National Drug Code (NDC) number for Vclear Berry Dissolving Tablets is 59800-3656. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Vclear Berry Dissolving Tablets drug includes 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 Pelargonium Sidoides Root - 1 [hp_X]/1 Phosphorus - 6 [hp_X]/1 . The currest status of Vclear Berry Dissolving Tablets drug is Active.
Drug Information:
| Drug NDC: | 59800-3656 |
| 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: | Vclear Berry Dissolving Tablets |
| 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, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus |
| 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: | 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
PELARGONIUM SIDOIDES ROOT - 1 [hp_X]/1
PHOSPHORUS - 6 [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: | 24 Sep, 2020 |
| 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. |
| 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 |
|---|
| 59800-3656-1 | 2 BLISTER PACK in 1 CARTON (59800-3656-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK | 24 Sep, 2020 | 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 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/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat.
Product Elements:
Vclear berry dissolving tablets pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus pelargonium sidoides root pelargonium sidoides root aconitum napellus aconitum napellus bryonia alba root bryonia alba root eucalyptus globulus leaf eucalyptus globulus leaf eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top gelsemium sempervirens root gelsemium sempervirens root ipecac ipecac phosphorus phosphorus annatto beet juice caramel lactose monohydrate magnesium stearate malic acid maltodextrin mannitol croscarmellose sodium sorbitol stearic acid xylitol natural berry flavor pink with pinkish-purple specks c c
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/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 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 stop use and ask a doctor is new symptoms occur, symptoms worsen or do not get better within 7 days, fever wrosens or lasts more than 3 days, cough lasts more than days or occurs with rash or persistant headache. these could be signs of a serious condition.
Dosage and Administration:
Dosage & administration 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 & children 13 years of age and older: take 1 dissolvable tablet 3 times daily. children 6-12 years of age: take 1 dissolvable tablet 2 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 irritations, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat. 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/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, s
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Stop Use:
Stop use stop use and ask a doctor is new symptoms occur, symptoms worsen or do not get better within 7 days, fever wrosens or lasts more than 3 days, cough lasts more than days or occurs with rash or persistant headache. these could be signs of a serious condition.
Overdosage:
Overdosage in case of overdose, seek medical help or contact a poison control center immediately.
Package Label Principal Display Panel:
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