Brillia Adult
Lapine S-100 Immune Globulin 12 Hpc, 30 Hpc, 200 Hpc
Hadaf Llc
Human Otc Drug
NDC 72123-003Brillia Adult also known as Lapine S-100 Immune Globulin 12 Hpc, 30 Hpc, 200 Hpc is a human otc drug labeled by 'Hadaf Llc'. National Drug Code (NDC) number for Brillia Adult is 72123-003. This drug is available in dosage form of Pill. The names of the active, medicinal ingredients in Brillia Adult drug includes Lapine S-100 Immune Globulin - 12 [hp_C]/1 . The currest status of Brillia Adult drug is Active.
Drug Information:
| Drug NDC: | 72123-003 |
| 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: | Brillia Adult |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Brillia |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Adult |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Lapine S-100 Immune Globulin 12 Hpc, 30 Hpc, 200 Hpc |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hadaf Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Pill |
| 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: | LAPINE S-100 IMMUNE GLOBULIN - 12 [hp_C]/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: | 19 Jan, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| 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: | Hadaf LLC
|
| 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: | 0372123000022
|
| UPC stands for Universal Product Code. |
| UNII: | A4FH976KAQ
|
| 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 |
|---|
| 72123-003-01 | 3 BLISTER PACK in 1 BOX (72123-003-01) / 20 PILL in 1 BLISTER PACK | 17 Sep, 2019 | 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 improve emotional regulation, focus, and attention
Product Elements:
Brillia adult lapine s-100 immune globulin 12 hpc, 30 hpc, 200 hpc lactose monohydrate anhydrous lactose magnesium stearate microcrystalline cellulose lapine s-100 immune globulin lapine s-100 immune globulin round b
Indications and Usage:
Uses reduce feelings of anxiety, restlessness, and stress reduce feelings of irritability reduce feelings of impulsivity improve concentration of attention enhance clarity
Warnings:
Warnings ask a doctor or pharmacist before use if you are lactose-intolerant stop use and ask a doctor if symptoms persist or worsen if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control right away. allergic (hypersensitivity) reactions may occur in very rare cases. do not use if known sensitivity to brillia or any of its ingredients exists.
Dosage and Administration:
Directions adults (18 years and older) to hold 1-2 tablets in the mouth until completely dissolved. should be taken 2-4 times daily for 3 months recommended to stop for 1-2 months (if symptoms do not return) after each 3 month regimen. take no later than 2 hours before bedtime as this product has activating properties
Package Label Principal Display Panel:
Brillia for adults final label may 2020