NDC 70677-0078 Sunmark Maximum Strength Urinary Pain Relief

Phenazopyridine Hydrochloride

NDC Product Code 70677-0078

NDC Code: 70677-0078

Proprietary Name: Sunmark Maximum Strength 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: OVAL (C48345)
Size(s):
9 MM
Score: 1

NDC Code Structure

  • 70677 - Strategic Sourcing Services Llc
    • 70677-0078 - Sunmark Maximum Strength Urinary Pain Relief

NDC 70677-0078-1

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

NDC Product Information

Sunmark Maximum Strength Urinary Pain Relief with NDC 70677-0078 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Sunmark Maximum Strength Urinary Pain Relief is phenazopyridine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Strategic Sourcing Services Llc

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.

Sunmark Maximum Strength 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.

  • PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg/1

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.

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

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: Strategic Sourcing Services Llc
Labeler Code: 70677
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: 09-12-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sunmark Maximum Strength Urinary Pain Relief Product Label Images

Sunmark Maximum Strength 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

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 tractinfections.

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

* Please review the disclaimer below.