NDC 0363-8455 Wallgreens Maximum Strength Urinary Pain Relief
Phenazopyridine Hydrochloride Tablet Oral

Product Information

Product Code0363-8455
Proprietary Name 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.
Wallgreens Maximum Strength Urinary Pain Relief
Non-Proprietary Name 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.
Phenazopyridine Hydrochloride
Product Type 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.
Human Otc Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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.
Wallgreens Co.
Labeler Code0363
Marketing Category 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.
UNAPPROVED DRUG OTHER -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-10-2019
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)BROWN (C48332)
ShapeOVAL (C48345)
Size(s)9 MM
Imprint(s)P99
Score1

Product Packages

NDC 0363-8455-12

Package Description: 1 BLISTER PACK in 1 CARTON > 12 TABLET in 1 BLISTER PACK

NDC 0363-8455-24

Package Description: 1 BLISTER PACK in 1 CARTON > 24 TABLET in 1 BLISTER PACK

Product Details

Wallgreens Maximum Strength Urinary Pain Relief is a human over the counter drug product labeled by Wallgreens Co.. The generic name of Wallgreens Maximum Strength Urinary Pain Relief is phenazopyridine hydrochloride. The product's dosage form is tablet and is administered via oral form.


What are Wallgreens Maximum Strength Urinary Pain Relief Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM SILICATE (UNII: 9B9691B2N9)


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Patient Education

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]

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Wallgreens Maximum Strength Urinary Pain Relief Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient (In Each Tablet)



Phenazopyridine Hydrochloride 99.5 mg .


Purpose



Urinary Analgesic


Warnings



Do not exceed recommended dosage


Ask Doctor Before Use If You Have



■ kidney disease
■ allergies to food, preservatives or dyes
■ had a hypersensitive reaction to phenazopyridine


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 Breast Feeding,



Ask a health professional before use.


Keep Out Of Reach Of Children



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


Use



Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract
infections.


Inactive Ingredients



Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.


Directions




■ adults and children 12 years and over:
take 2 tablets 3 times daily with a full glass of water, with or after meals as needed

■ children under 12 years: consult a doctor

■ Do not use for more than 2 days (12 tablets) without consulting a doctor


Package Label.Principal Display Panel




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