Unda 700
Berberis Vulgaris, Calcarea Fluorica
Seroyal Usa
Human Otc Drug
NDC 62106-1171Unda 700 also known as Berberis Vulgaris, Calcarea Fluorica is a human otc drug labeled by 'Seroyal Usa'. National Drug Code (NDC) number for Unda 700 is 62106-1171. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Unda 700 drug includes Berberis Vulgaris Root Bark - 4 [hp_X]/20mL Calcium Fluoride - 12 [hp_X]/20mL . The currest status of Unda 700 drug is Active.
Drug Information:
| Drug NDC: | 62106-1171 |
| 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: | Unda 700 |
| 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: | Berberis Vulgaris, Calcarea Fluorica |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Seroyal Usa |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | BERBERIS VULGARIS ROOT BARK - 4 [hp_X]/20mL CALCIUM FLUORIDE - 12 [hp_X]/20mL
|
| 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: | 23 Sep, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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: | Seroyal USA
|
| 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: | 0883196304608
|
| UPC stands for Universal Product Code. |
| UNII: | 1TH8Q20J0U 046Y1357I6 O3B55K4YKI Q1RGP4UB73 YQ2S06L8S9 DTN01M69SN IDB0NAZ6AI 75O014T1HG M7T6H7D4IF
|
| 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 |
|---|
| 62106-1171-8 | 1 BOTTLE, GLASS in 1 CARTON (62106-1171-8) / 20 mL in 1 BOTTLE, GLASS | 23 Sep, 2015 | 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:
Uses for the relief of symptoms associated with sore throat.
Uses for the relief of symptoms associated with low energy and fatigue
Product Elements:
Unda 700 berberis vulgaris, calcarea fluorica berberis vulgaris root bark berberis vulgaris root bark calcium fluoride fluoride ion alcohol water unda 312 angelica archangelica, drosera, grindelia, lamium album, pinus sylvestris, rubus fruticosus, senega officinalis drosera rotundifolia flowering top drosera rotundifolia flowering top grindelia hirsutula flowering top grindelia hirsutula flowering top pinus sylvestris leafy twig pinus sylvestris leafy twig alcohol water angelica archangelica root angelica archangelica root lamium album lamium album rubus fruticosus leaf rubus fruticosus leaf polygala senega root polygala senega root
Indications and Usage:
Uses for the relief of symptoms associated with sore throat. directions adults and adolescents (12 years and older): take 5 drops three times daily or as recommended by your healthcare practitioner. children (under 12 years): take under the direction of your healthcare practitioner.
Uses for the relief of symptoms associated with low energy and fatigue directions adults and adolescents (12 years and older): take 5 drops three times daily or as recommended by your healthcare practitioner. children (under 12 years): take under the direction of your healthcare practitioner.
Warnings:
Warnings sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. consult physician promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by physician. ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. cough that is accompanied by excessive phlegm (mucus) or fever. stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. stop use and ask a doctor if symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Warnings stop use and ask a doctor if symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. consult physician promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by physician. ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. cough that is accompanied by excessive phlegm (mucus) or fever. stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. stop use and ask a doctor if symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Warnings stop use and ask a doctor if symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions adults and adolescents (12 years and older): take 5 drops three times daily or as recommended by your healthcare practitioner. children (under 12 years): take under the direction of your healthcare practitioner.
Directions adults and adolescents (12 years and older): take 5 drops three times daily or as recommended by your healthcare practitioner. children (under 12 years): take under the direction of your healthcare practitioner.
Stop Use:
Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. stop use and ask a doctor if symptoms persist or worsen.
Stop use and ask a doctor if symptoms persist or worsen.
Overdosage:
In case of overdose, get medical help or contact a poison control center right away.
In case of overdose, get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Unda ndc 62106-1169-8 numbered compounds unda 312 homeopathic preparation for the relief of symptoms associated with sore throat. contains 31% alcohol 0.7 fl oz (20 ml) 62106-1169
Unda ndc 62106-1171-8 numbered compounds unda 700 homeopathic preparation contains 31% alcohol 0.7 fl oz (20 ml) ndc