Azo
Urinary Pain Relief
I-health, Inc.
Human Otc Drug
NDC 49973-301Azo also known as Urinary Pain Relief is a human otc drug labeled by 'I-health, Inc.'. National Drug Code (NDC) number for Azo is 49973-301. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Azo drug includes Phenazopyridine Hydrochloride - 95 mg/1 . The currest status of Azo drug is Active.
Drug Information:
| Drug NDC: | 49973-301 |
| 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 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Urinary Pain Relief |
| 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 - 95 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: | 24 May, 2012 |
| 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: | 1094126
1094192
|
| 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. |
| 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 |
|---|
| 49973-301-31 | 15 BLISTER PACK in 1 BOX (49973-301-31) / 2 TABLET in 1 BLISTER PACK | 24 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. |
Purpose:
Purpose urinary analgesic
Product Elements:
Azo urinary pain relief phenazopyridine hydrochloride phenazopyridine cellulose, microcrystalline starch, corn hypromelloses povidone, unspecified croscarmellose sodium polyethylene glycol, unspecified carnauba wax magnesium stearate maroon tablet w
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. caution: do not use this product 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 your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication.
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. caution: do not use this product 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 your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication.
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.
General Precautions:
Other inf ormation this product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests this product may stain soft contact lenses and other items if handled after touching tablets store at room temperature (59-86 f) in a dry place and protect from light tamper evident: tablets sealed in blisters. do not use if blister foil or seal is open or damaged.
Dosage and Administration:
Directions adults and children 12 years or 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 your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication.
Package Label Principal Display Panel:
Azo urinary pain relief relieves pain, burning & urgency targets the source of pain #1 most trusted brand tablets 95 mg phenazopyridine hydrochloride azo upr label combined azo upr 95
Further Questions:
Distributed by i-health, inc. 55 sebethe drive, cromwell, ct 06416 made in india. most trusted brand based on nielsen data through 3/23/2013. for questions, concerns, or to report an adverse event, call (800) 722-3476 www.azoproducts.com