Uricalm Maximum Strength
Phenazopyridine Hydochloride
Alva-amco Pharmacal Companies, Inc.
Human Otc Drug
NDC 52389-241Uricalm Maximum Strength also known as Phenazopyridine Hydochloride is a human otc drug labeled by 'Alva-amco Pharmacal Companies, Inc.'. National Drug Code (NDC) number for Uricalm Maximum Strength is 52389-241. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Uricalm Maximum Strength drug includes Phenazopyridine Hydrochloride - 99.5 mg/1 . The currest status of Uricalm Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 52389-241 |
| 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: | Uricalm Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Uricalm |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Maximum Strength |
| 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: | Phenazopyridine Hydochloride |
| 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: | PHENAZOPYRIDINE HYDROCHLORIDE - 99.5 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: | 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: | 29 Apr, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 Jun, 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: | 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: | 1094147
1094149
|
| 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: | 0072959415242
|
| UPC stands for Universal Product Code. |
| UNII: | 0EWG668W17
|
| 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 |
|---|
| 52389-241-24 | 1 BLISTER PACK in 1 CARTON (52389-241-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-01) | 29 Apr, 2008 | N/A | No |
| 52389-241-28 | 1 BLISTER PACK in 1 CARTON (52389-241-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-04) | 20 Feb, 2014 | N/A | No |
| 52389-241-48 | 2 BLISTER PACK in 1 CARTON (52389-241-48) / 24 TABLET, FILM COATED in 1 BLISTER PACK | 18 Oct, 2021 | 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 urinary analgesic
Product Elements:
Uricalm maximum strength phenazopyridine hydochloride cranberry fd&c red no. 40 fd&c yellow no. 6 hypromelloses light mineral oil titanium dioxide triacetin croscarmellose sodium magnesium stearate cellulose, microcrystalline povidone silicon dioxide polyethylene glycol 400 talc starch, corn phenazopyridine hydrochloride phenazopyridine alva;1
Indications and Usage:
Uses prompt temporary relief of: pain during urination burning sensation of urgency increased frequency associated with urinary tract infections.
Warnings:
Warnings
Do Not Use:
Warnings
When Using:
When using this product stomach upset may occur; taking this product with or after meals may reduce stomach upset you may experience a reddish-orange discoloration of the urine which is a non-harmful temporary effect.
Dosage and Administration:
Directions read all package directions and warnings before use. use only as directed. do not exceed recommended dosage. adults: swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum. swallow whole. do not crush or chew. do not use more than 12 tablets in 2 days. drink 6 to 8 eight 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 your symptoms do not go away after two days or become worse you experience fever, chills, back pain or bloody urine you suspect you are having an adverse reaction to this medication.
Information for Patients:
Other information warning: this product contains a chemical known to the state of california to cause cancer. precaution: carcinogenesis: long-term administration of phenazopyridine hcl has induced neoplasia in rats (large intestine) and mice (liver) . although no association between phenazopyridine hcl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. **contents sealed: each uricalm max dark red colored, round shaped tablet bears the identifying mark "alva" and a "1" on the reverse side, and is sealed in a clear plastic blister with with foil backing. do not use if seal appears broken or if product contents do not match product description. this product may stain soft contact lenses. this product can interfere with laboratory tests including urine, glucose (sugar) and ketones. you may report serious side effects to the phone number provided under questions? below.
Spl Patient Package Insert:
Product insert doctor recommended uricalm max 199 mg strong per dose the highest dose of clinically proven phenazopyridine hydrochloride available over the counter, plus cranberry uricalm max provides the maximum non-prescription strength of clinically proven phenazopyridine hydrochloride to relieve pain, burning, increased frequency, and sensation of urgency associated with urinary tract infections. uricalm max has 99.5 mg of phenazopyridine hydrochloride per tablet - no other otc brand contains more. plus, uricalm max contains cranberry, which is used extensively by those concerned about urinary tract health. active ingredient (in each tablet): phenazopyridine hydrochloride 99.5 mg purpose: urinary analgesic uses: prompt temporary relief of pain during urination burning sensation of urgency increased frequency associated with urinary tract infections. warnings do not use if you have liver or kidney problems allergies to foods, preservatives or dyes had a hypersensitive reaction to ph
Read more...enazopyridine hydrochloride when using this product stomach upset may occur; taking this product with or after meals may reduce stomach upset you may experience a reddish-orange discoloration of the urine which is a non-harmful temporary effect. ask a doctor or pharmacist before use if you are taking any other medications. stop use and ask a doctor if your symptoms do not go away after two days or become worse you experience fever, chills, back pain or bloody urine. you suspect you are having an adverse reaction to this medication if pregnant or breast-feeding, 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. directions: read all package directions and warnings before use. use only as directed. do not exceed recommended dosage. adults: swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum. swallow whole. do not crush or chew. do not use more than 12 tablets in 2 days drink 6 to 8 glasses of water daily. for use by normally healthy persons only. persons under 18 years of age should use only as directed by a doctor. other information: warning: this product contains a chemical known to the state of california to cause cancer. precaution: carcinogenesis: long-term administration of phenazopyridine hcl has induced neoplasia in rats (large intestine) and mice (liver). although no association between phenazopyridine hcl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. **contents sealed: each uricalm max dark red colored, round shaped tablet bears the identifying mark "alva" and a "1" on the reverse side, and is sealed in a clear plastic blister with foil backing. do not use if seal appears broken or if product contents do not match product description. this product may stain soft contact lenses. this product can interfere with laboratory tests including urine, glucose (sugar) and ketones. you may report serious side effects to the phone number provided under questions? below. inactive ingredients: corn starch, cranberry fruit powder, croscarmellose sodium, fd&c red no. 40 lake, fd&c yellow no. 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, talc, titanium dioxide and triacetin. questions? 1-800-792-2582 www.uricalm.com recomendado por mÃdicos uricalm max 199 mg de concentración por dosis contiene la dosis más alta de phenazopyridine hydrochloride clÃnicamente comprobado disponible en venta sin receta, además de arándano uricalm max ofrece la dosis más alta de phenazopyridine hydrochloride clÃnicamente comprobado de venta sin receta para aliviar el dolor, el ardor, el aumento en la frequencia y la sensación de necesidad urgente de orinar asociados con las infecciones del tracto urinario. uricalm max tiene 99.5 mg de phenazopyridine hydrochloride por tableta; ninguna otra marca de venta sin receta contiene más. además, uricalm max contiene arándano, que es usado ampliamente por quienes se preocupan por la salud del tracto urinario. ingrediente activo (in cada tableta): phenazopyridine hydrochloride 99.5 mg propósito: analgésico urinario usos: alivio rápido y temporal del dolor durante la micción del ardor de la sensación de necesidad urgente de orinar del aumento en la frecuencia asociada con las infecciones del tracto urinario. advertencias: no lo use si tiene problemos hepático o renales alergias a los alimentos, conservantes o colorantes ha tenido una reacción hipersensible al phenazopyridine hydrochloride cuando se use este producto puede presentarse malestar estomical; la ingestión de este producto con alimentos o después de comer puede reducir el malestar estomacal puede experimentar un color de rojizo a anaranjado en la orina, lo cual es un efecto temporal inofensivo. consulte con un médico o farmacéutico antes de usarlo si está tomando cualquier otro medicamento. interrumpa el uso y consulte con su médico si los sÃntomas no desaparecen o empeoran después de dos dias tiene fiebre, escalofrÃos, dolor de espalda o nota la presencia de sangre en la orina. sospecha que está experimentado una reacción adversa a este medicamento. si está embarazada o lactando, consulte con un profesional de la salud antes de usario. manténgalo fuera del alcance de los niños. en caso de sobredosis, obtenga ayuda médica o comunÃquese de inmediato con un centro de toxicologia. indicaciones: lea todos las indicaciones y advertencias en el envase antes de usarlos. Ãselo únicamente como se indica. no exceda la dosis recomendada. adultos: ingiera dos (2) tabletas con agua después de las comidas según sea necesario hasta 3 veces al dÃa por un máximo de 2 dias. trague la tablets entera. no triture ni mastique la tableta. no use más de 12 tabletas en 2 dÃas. tome de 6 a 8 vasos de agua todos los dias. para usarlo en adultos normalmente sanos únicamente. las personas menores de 18 años deben usarlo solo según las indicaciones de un médico. información adicional: advertencia: este producto contiene una sustancia quimica que en el estado de california se sabe que causa cáncer. precaución: carcinogénesis: la administración a largo plazo del phenazopyridine hydrochloride ha inducido neoplasia en ratas (intestino grueso) y en ratones (hÃgado). aunque no ha sido informada una asociación entre el phenazopyridine hydrochloride y la neoplasia en seres humanos, no se han realizado estudios epidemiológicos adecuados sobre esto. **el contenido está sellado cada tableta uricalm max de color rojo oscuro y redonda lleva la marca identificadora "alva" y un "1" en el dorso, y está sellada en un blÃster de plástico transperente con un recubrimiento posterior de papel aluminio. no lo use si el sello parece estar roto o si el producto no coincide con la descripción del producto. este producto puede causar manchas en los lentes de contacto blandos. este producto puede interferir con las pruebas de laboratorio incluidas orina, glucosa (azúcar) y cetonas. puede informar efectos secundarios graves al número de teléfono que aparece en la sección ¿tiene preguntas? a continuación. ingredientes inactivos: almidón de maÃz, polvo de la fruta de arándano, croscarmelosa sódica, fd&c rojo no. 40 lake, fd&c amarillo no. 6 lake, hipromelosa, estearato de magnesio, celulosa microcristalina, aceite mineral, polietilenglicol, polivinilpirrolidona, almidón pregelatinizado, dióxido de silicio, talco, dióxido de titanio y tracetino. ¿tiene preguntas? 1-800-792-2582 www.uricalm.com
Package Label Principal Display Panel:
Uricalmpdp
Further Questions:
Questions? 1-800-792-2582.