Diurex Water Pills

Caffeine, Magnesium Salicylate

Alva-amco Pharmacal Companies, Inc.
Human Otc Drug
NDC 52389-306

Diurex Water Pills also known as Caffeine, Magnesium Salicylate is a human otc drug labeled by 'Alva-amco Pharmacal Companies, Inc.'. National Drug Code (NDC) number for Diurex Water Pills is 52389-306. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Diurex Water Pills drug includes Caffeine - 50 mg/1 Magnesium Salicylate - 162.5 mg/1 . The currest status of Diurex Water Pills drug is Active.

Drug Information:

Drug NDC:	52389-306
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 Water Pills
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:	Water Pills
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:	Caffeine, Magnesium Salicylate
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, 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:	CAFFEINE - 50 mg/1 MAGNESIUM SALICYLATE - 162.5 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:	OTC MONOGRAPH NOT FINAL
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:	15 May, 2005
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.
Application Number:	part343
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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:	1001437
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:	0072959065423
UPC stands for Universal Product Code.
NUI:	N0000175739 N0000175729 N0000175790 M0023046
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	3G6A5W338E 41728CY7UX
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.
Pharmacologic Class EPC:	Central Nervous System Stimulant [EPC] Methylxanthine [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Central Nervous System Stimulation [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Xanthines [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Central Nervous System Stimulant [EPC] Central Nervous System Stimulation [PE] Methylxanthine [EPC] Xanthines [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
52389-306-36	2 BLISTER PACK in 1 CARTON (52389-306-36) / 18 TABLET, COATED in 1 BLISTER PACK	14 Feb, 2020	N/A	No
52389-306-42	1 BLISTER PACK in 1 CARTON (52389-306-42) / 42 TABLET, COATED in 1 BLISTER PACK (52389-306-01)	15 May, 2005	N/A	No
52389-306-84	2 BLISTER PACK in 1 CARTON (52389-306-84) / 42 TABLET, COATED in 1 BLISTER PACK (52389-306-01)	02 May, 2012	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.

Other medicines with the same generic name

Diurex Water Pills

Caffeine, Magnesium Salicylate

Tablet, Coated
Alva-Amco Pharmacal Companies, Inc.
NDC: 52389-306

Purpose:

Purpose diuretic analgesic (pain reliever)

Product Elements:

Diurex water pills caffeine, magnesium salicylate acacia calcium carbonate starch, corn crospovidone fd&c blue no. 1 hypromelloses magnesium stearate maltodextrin cellulose, microcrystalline light mineral oil polyethylene glycol 400 polysorbate 80 silicon dioxide sodium starch glycolate type a potato stearic acid talc titanium dioxide triacetin magnesium salicylate salicylic acid caffeine caffeine alva

Indications and Usage:

Uses for temporary relief of temporary water retention bloat swelling full feeling fatigue minor aches and pains associated with the premenstrual and menstrual periods.

Warnings:

Warnings reye's syndrome: children and teenagers should not use this product for chicken pox or flu symptoms before a doctor is consulted about reye's syndrome, a rare but serious illness reported to be associated with aspirin. allergy alert: magnesium salicylate may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock stomach bleeding warning: this product contains a non-steroidal anti-inflammatory drug (nsaid), which may cause severe stomach bleeding. the chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed.

Do Not Use:

When Using:

When using this product, limit the use of caffeine containing medications, foods or beverages because too much caffeine may cause: nervousness irritability sleeplessness occasional rapid heart beat the recommended dose of this product contains about as much caffeine as one cup of coffee.

Dosage and Administration:

Directions read all package directions and warnings before use and use only as directed. adults: two (2) pills every 4 to 6 hours while symptoms persist, not to exceed eight (8) pills per day. 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. note: diurex water pills will not discolor urine.

Stop Use:

Stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. pain gets worse or lasts more than 10 days. fever gets worse or lasts more than 3 days. redness or swelling is present. ringing in the ears or loss of hearing occurs. any new symptoms appear. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better.

Information for Patients:

Other information magnesium content: 15 mg/pill, calcium content: 10 mg/pill **contents sealed: each diurex blue colored, round shaped pill bears the identifying mark âalva" 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. you may report serious side effects to the phone number provided under questions? below.

Package Label Principal Display Panel:

Diurexwaterpillspdp

Further Questions:

Questions? 1-800-792-2582

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.