Azo Urinary Pain Relief Maximum Strength
Phenazopyridine Hydrochloride
I-health, Inc.
Human Otc Drug
NDC 49973-247Azo Urinary Pain Relief Maximum Strength also known as Phenazopyridine Hydrochloride is a human otc drug labeled by 'I-health, Inc.'. National Drug Code (NDC) number for Azo Urinary Pain Relief Maximum Strength is 49973-247. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Azo Urinary Pain Relief Maximum Strength drug includes Phenazopyridine Hydrochloride - 99.5 mg/1 . The currest status of Azo Urinary Pain Relief Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 49973-247 |
| 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: | Azo Urinary Pain Relief Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Azo Urinary Pain Relief |
| 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 Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | I-health, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | 02 Jul, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 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: | i-Health, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1094147
2048946
|
| 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: | 0787651122533
0787651241531
|
| 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 |
|---|
| 49973-247-12 | 6 BLISTER PACK in 1 BOX (49973-247-12) / 2 TABLET in 1 BLISTER PACK | 02 Jul, 2018 | N/A | No |
| 49973-247-24 | 12 BLISTER PACK in 1 BOX (49973-247-24) / 2 TABLET in 1 BLISTER PACK | 02 Jul, 2018 | N/A | No |
| 49973-247-96 | 48 BLISTER PACK in 1 BOX (49973-247-96) / 2 TABLET in 1 BLISTER PACK | 22 Feb, 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 urinary tract analgesic
Product Elements:
Azo urinary pain relief maximum strength phenazopyridine hydrochloride phenazopyridine hydrochloride phenazopyridine cellulose, microcrystalline starch, corn hypromelloses povidone croscarmellose sodium polyethylene glycol, unspecified carnauba wax magnesium stearate maroon 99
Indications and Usage:
Use relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Warnings:
Warnings please read insert for important precautions. ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to phenazopyridine hydrochloride do not use if you have glucose-6-phosphate dehydrogenase (g6pd) deficiency unless approved by your physician. when using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset your urine will become reddish-orange in color. this is not harmful, but care should be taken to avoid staining clothing or other items. stop use and ask doctor if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication. if pregnant or breastfeeding, ask a professional before use. a pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. keep out of reach of children. in case of an overdose, get medical help or contact a poison control center right away.
Read more... Do Not Use:
Warnings please read insert for important precautions. ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to phenazopyridine hydrochloride do not use if you have glucose-6-phosphate dehydrogenase (g6pd) deficiency unless approved by your physician. when using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset your urine will become reddish-orange in color. this is not harmful, but care should be taken to avoid staining clothing or other items. stop use and ask doctor if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication. if pregnant or breastfeeding, ask a professional before use. a pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. keep out of reach of children. in case of an overdose, get medical help or contact a poison control center right away.
When Using:
When using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset your urine will become reddish-orange in color. this is not harmful, but care should be taken to avoid staining clothing or other items.
Dosage and Administration:
Directions adults and children 12 years and older: take 2 tablets 3 times daily with or after meals as needed for up to two days. take with a full glass of water. do not use for more than 2 days (12 tablets) without consulting a doctor. children under 12: do not use without consulting a doctor.
Stop Use:
Stop use and ask doctor if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication.
Spl Patient Package Insert:
Azo urinary pain relief ® maximum strength urinary pain relief tablets active ingredient: each analgesic tablet contains phenazopyridine hydrochloride 99.5 mg. fast relief of urinary discomfort including common urinary tract infection symptoms: urinary pain, burning, urgency and frequency . urinary tract infection (uti) symptoms of urinary discomfort may indicate a urinary tract infection. if you experience symptoms such as urinary pain, burning, urgency and frequency, you need to call your doctor to get diagnosed and obtain a prescription to treat the infection. while you wait to get to the doctor and for the prescription to begin to work, you can get fast, symptomatic relief with azo urinary pain relief maximum strength . warnings ask a doctor before use if you have : liver or kidney trouble allergies to foods, preservatives or dyes had a hypersensative reaction to phenazopyridine hydrochloride do not use : if you have glucose-6-phosphate dehydrogenase (g6pd) deficiency unless app
Read more...roved by your physician. when using this product stomach upset may occur. taking with or after meals may reduce stomach upset. your urine will become reddish-orange in color. this is not harmful, but care should be taken to avoid staining clothing or other items . stop using ths product and ask a doctor if you think you may be having an adverse reaction to the medication or if your symptoms last for more than two days. if you are pregnant or breastfeeding , ask a healthcare professional before you use this product. a pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use . keep this medication out of the reach of children . in case of an overdose, get medical help or contact a poison control center right away. directions adults and children 12 years and older : take two (2) tablets three (3) times daily for up to two days. take with a full glass of water, with or after meals as needed. do not use for more than two days (12 tablets) without consulting a doctor. children under age 12 : do not use without consulting a doctor. other information & precautions this product can interfere with laboratory tests including urine, glucose (sugar) and keytones. this product may stain soft contact lenses and other items if handled after touching tablets. size and color of tablets may vary. carcinogenesis : long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. storage : store at room temperature (59° - 86°f) in a dry place and protect from light. tamper evident : product is sealed within blisters. do not use if any part of the blister is torn, open or damanged. for questions, concerns, or to report an adverse event, please call (800) 722-3476 or visit www.azoproducts.com azo urinary pain relief ® maximum strength alivio rápido para el dolor de las vÃas urinarias ingrediente activo: cada tableta de analgésico contiene 99.5 mg de hidrocloruro de fenazopiridina. alivio rápido de la incomodidad en las vÃas urinarias que incluye los sÃntomas comunes de infección en las vÃas urinarias: dolor al orinar, ardor, urgencia y frecuencia. infecciÃn de las vÃas urinarias los sÃntomas de incomodidad en las vÃas urinarias pueden indicar la presencia de una infección. si tiene sÃntomas como dolor, ardor, urgencia y frecuencia, necesita llamar a su médico para recibir un diagnóstico y que le dé una receta para tratar la infección. mientras espera para ver al doctor y para que el medicamento que le recete comience a funcionar, puede obtener un alivio rápido de sus sÃntomas con azo urinary pain relief® maximum strength. advertencias consulte a su médico antes de usar este producto si : ⢠tiene problemas renales o hepáticos. ⢠tiene alergias a alimentos, conservadores o tintes. ⢠ha tenido una reacción alérgica a el hidrocloruro de fenazopiridina. no usar : si tiene una deficiencia de glucosa-6-fosfato deshidrogenasa (g6pd), a menos que su médico lo apruebe. al usar este producto: ⢠puede sentir malestar estomacal. tómelo durante o después de las comidas para ayudar a disminuir el malestar. ⢠la orina adquiere un color anaranjado rojizo. esto no es dañino, pero debe tener cuidado para evitar manchar a ropa u otros artÃculos. deje de usar este producto y consulte a su médico si piensa que puede estar teniendo una reacción adversa al medicamento o si sus sÃntomas duran más de dos dÃas. si usted está embarazada o lactando , consulte a un profesional médico antes de usar este producto. se recomienda una prueba de embarazo y una consulta con un profesional médico si se confirma un embarazo antes de usar el producto. mantenga este medicamento fuera del alcance de los niños . en caso de una sobredosis, consiga atención médica o comunÃquese con un centro de control de envenenamiento de inmediato. instrucciones adultos y niños mayores de 12 año s: tome dos (2) tabletas tres (3) veces al dÃa hasta dos dÃas. tome con un vaso de agua, durante o después de las comidas, según sea necesario. no lo utilice durante más de 2 dÃas (12 tabletas) sin consultar a un médico. niños menores de 12 años : no se utilice sin consultar a un médico. otra informaciÃn y precauciones ⢠este producto puede interferir con los análisis de laboratorio, incluso los análisis de orina, glucosa (azúcar) y cetonas. ⢠este producto puede manchar los lentes de contacto blandos y otros artÃculos si los manipula después de tocar las tabletas. ⢠el tamaño y el color de las tabletas puede variar. ⢠carcinogénesis : la administración a largo plazo del hidrocloruro de fenazopiridina ha inducido neoplasia en ratas (intestino grueso) y ratones (hÃgado). aunque no se ha informado acerca de ningún caso que relacione el hidrocloruro de fenazopiridina con la neoplasia en humanos, no se han efectuado estudios epidemiológicos adecuados al respecto. ⢠almacenaje : almacénese a temperatura ambiental (15° a 30°c) en un sitio seco, y protéjase de la luz. ⢠evidencia de alteraciones: el producto viene sellado en blÃsteres. no lo use si alguna parte del blÃster está rota, abierta o dañada. para preguntas, dudas o para informar acerca de una reacción adversa, llame al (800) 722-3476 o visite www.azoproducts.com
Package Label Principal Display Panel:
Relief that's fast azo urinary pain relief® maximum strength strongest uti pain reliever available+ even higher dose to releive pain, burning & urgency+ targets the source of pain #1 most trusted brand* __ tablets 99.5 mg phenazopyridine hydrochloride +among azo urinary pain relief® products. * #1 most trusted brand based on total azo brand nielsen data through 1/20/18 and the 2017 pharmacy times survey (urinary pain relief and cranberry supplement categories). upr 12 upr 24 upr english insert upr spanish insert upr 96 upr 96 english insert upr 96 spanish insert