Diurex Max
Pamabrom
Alva-amco Pharmacal Companies, Inc.
Human Otc Drug
NDC 52389-249Diurex Max also known as Pamabrom is a human otc drug labeled by 'Alva-amco Pharmacal Companies, Inc.'. National Drug Code (NDC) number for Diurex Max is 52389-249. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Diurex Max drug includes Pamabrom - 50 mg/1 . The currest status of Diurex Max drug is Active.
Drug Information:
| Drug NDC: | 52389-249 |
| 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: | Diurex Max |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Diurex |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Max |
| 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: | Pamabrom |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alva-amco Pharmacal Companies, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| 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: | PAMABROM - 50 mg/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 DRUG OTHER |
| 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: | 20 Dec, 1995 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | Alva-Amco Pharmacal Companies, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 199158
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0072959495244
|
| UPC stands for Universal Product Code. |
| UNII: | UA8U0KJM72
|
| 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 |
|---|
| 52389-249-10 | 4 BLISTER PACK in 1 CARTON (52389-249-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 Nov, 2017 | N/A | No |
| 52389-249-24 | 1 BLISTER PACK in 1 CARTON (52389-249-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK | 18 Apr, 2011 | N/A | No |
| 52389-249-30 | 3 BLISTER PACK in 1 CARTON (52389-249-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 12 Jul, 2021 | N/A | No |
| 52389-249-48 | 2 BLISTER PACK in 1 CARTON (52389-249-48) / 24 TABLET, FILM COATED in 1 BLISTER PACK | 18 Jul, 2013 | N/A | No |
| 52389-249-50 | 5 BLISTER PACK in 1 CARTON (52389-249-50) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 18 Jul, 2022 | N/A | No |
| 52389-249-72 | 3 BLISTER PACK in 1 CARTON (52389-249-72) / 24 TABLET, FILM COATED in 1 BLISTER PACK | 12 Jun, 2018 | 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 diuretic
Product Elements:
Diurex max pamabrom calcium sulfate dihydrate croscarmellose sodium dibasic calcium phosphate dihydrate fd&c blue no. 1 hypromelloses magnesium stearate light mineral oil polyethylene glycol 400 potassium gluconate riboflavin sodium lauryl sulfate stearic acid titanium dioxide pamabrom bromotheophylline talc alva;1
Indications and Usage:
Uses for the relief of temporary water retention bloating swelling full feeling associated with the premenstrual and menstrual periods.
Warnings:
Warnings ask a doctor or pharmacist before use if you are taking any other medications. stop use and ask a doctor if symptoms last more than ten consecutive days.
Dosage and Administration:
Directions read all package directions and warnings before use. use only as directed. adults: one (1) pill after breakfast with a full glass of water. dose may be repeated after 6 hours, not to exceed four (4) pills in 24 hours. start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period. drink 6 to 8 glasses of water daily. for use by normally healthy adults only. persons under 18 years of age should use only as directed by a doctor.
Stop Use:
Stop use and ask a doctor if symptoms last more than ten consecutive days.
Information for Patients:
Other information calcium content: 160 mg/pill. **contents sealed: each diurex max, light blue colored, oval shaped pill bears the identifying mark "alva" plus a "1" on the pill's reverse side and is sealed in a clear plastic blister with a foil backing. do not use if seal appears broken or if product contents do not match product description. note: the appearance of golden tinted urine which may occur after taking diurex water pills is a normal and temporary effect. you may report serious side effects to the phone number provided under questions? below.
Package Label Principal Display Panel:
Diurexmaxpdp
Further Questions:
Questions? 1-800-792-2582