NDC 30142-757 Urinary Pain Relief

Phenazopyridine Hydrochloride

NDC Product Code 30142-757

NDC CODE: 30142-757

Proprietary Name: Urinary Pain Relief 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: Phenazopyridine Hydrochloride 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)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
S159
Score: 1

NDC Code Structure

  • 30142 - Kroger Company

NDC 30142-757-30

Package Description: 1 BLISTER PACK in 1 CARTON > 30 TABLET in 1 BLISTER PACK

NDC Product Information

Urinary Pain Relief with NDC 30142-757 is a a human over the counter drug product labeled by Kroger Company. The generic name of Urinary Pain Relief is phenazopyridine hydrochloride. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1094126.

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.

Urinary Pain Relief 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

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: Kroger Company
Labeler Code: 30142
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: 05-01-2021 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: 12-31-2022 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.

Urinary Pain Relief 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

Other

Drug Facts

DISTRIBUTED BY THE KROGER CO.CINCINNATI, OHIO 45202

Active Ingredient (In Each Tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary tract analgesic

Uses

Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions

Warnings

Do not exceed recommended dosage

Otc - Do Not Use

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

Ask A Doctor Before Use If You Have

  • Kidney diseaseallergies to foods, 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 upsetyour 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 A Doctor If

  • Your symptoms last for more than 2 daysyou suspect you are having an adverse reaction to the medicationlong-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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

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.

Directions

  • Adults and children 12 years and over: 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 doctorChildren under 12 years: Do not use without consulting a doctor

Other Information

  • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones testsThis product may stain contact lenses and other items if handled after touching tablets. Store at room temperature between 15°C -30°C (59°F -86°F) in a dry place and protect from light.

Inactive Ingredients

Colloidal silicone dioxide, gum acacia extra pure, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate

* Please review the disclaimer below.