NDC 49973-301 Azo

Urinary Pain Relief

NDC Product Code 49973-301

NDC CODE: 49973-301

Proprietary Name: Azo What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Urinary Pain Relief What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
BROWN (C48332 - MAROON)
Shape: ROUND (C48348)
Size(s):
7 MM
Imprint(s):
W
Score: 1

NDC Code Structure

NDC 49973-301-31

Package Description: 15 BLISTER PACK in 1 BOX > 2 TABLET in 1 BLISTER PACK

NDC Product Information

Azo with NDC 49973-301 is a a human over the counter drug product labeled by I-health, Inc.. The generic name of Azo is urinary pain relief. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1094126 and 1094192.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Azo Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POVIDONE (UNII: FZ989GH94E)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: I-health, Inc.
Labeler Code: 49973
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-24-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Phenazopyridine

Phenazopyridine is pronounced as (fen az oh peer' i deen)

Why is phenazopyridine medication prescribed?
Phenazopyridine relieves urinary tract pain, burning, irritation, and discomfort, as well as urgent and frequent urination caused by urinary tract infections, surgery, in...
[Read More]

* Please review the disclaimer below.

Azo Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Drug Facts

Active ingredient (in each tablet)Phenazopyridine Hydrochloride 95 mg

Otc - Purpose

PurposeUrinary analgesic

Indications & 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 havekidney diseaseallergies to foods, preservatives or dyeshad a hypersensitive reaction to Phenazopyridine Hydrochloride.

Otc - Do Not Use

Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

Otc - When Using

  • When using this productstomach 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.

Otc - Stop Use

  • Stop use and ask doctor your symptoms last for more than 2 daysyou suspect you are having an adverse reaction to the medication.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  In case of an overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsAdults 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.

General Precautions

  • Other InformationThis product can interfere with laboratory tests including urine, glucose (sugar), and ketones testsThis product may stain soft contact lenses and other items if handled after touching tabletsStore at room temperature (59-86 F) in a dry place and protect from lightTamper evident: tablets sealed in blisters.  Do not use if blister foil or seal is open or damaged.

Inactive Ingredient

Inactive ingredientsmicrocrystalline
cellulose, pregelatinized corn starch, hypromellose, povidine,
croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable
magnesium stearate.  May also contain corn starch.

Otc - Questions

Distributed by i-Health, Inc.55 Sebethe Drive, Cromwell, CT 06416Made in India.Most Trusted Brand based on Nielsen data through 3/23/2013.For questions, concerns, or to report an adverse event, call (800) 722-3476www.azoproducts.com

* Please review the disclaimer below.