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NDC 70000-0241-01 Leader Maximum Strength Urinary Pain Relief 97.5 mg/1 Details

Leader Maximum Strength Urinary Pain Relief 97.5 mg/1

Leader Maximum Strength Urinary Pain Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is PHENAZOPYRIDINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Phenazopyridine relieves urinary tract pain, burning, irritation, and discomfort, as well as urgent and frequent urination caused by urinary tract infections, surgery, injury, or examination procedures. However, phenazopyridine is not an antibiotic; it does not cure infections.

Related Packages: 70000-0241-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenazopyridine

Product Information

NDC	70000-0241
Product ID	70000-0241_16326945-97af-4f03-ab90-67614ed345a8
Associated GPIs	56300010100350
GCN Sequence Number	031436
GCN Sequence Number Description	phenazopyridine HCl TABLET 97.5 MG ORAL
HIC3	R5A
HIC3 Description	URINARY TRACT ANESTHETIC/ANALGESIC AGNT (AZO-DYE)
GCN	42125
HICL Sequence Number	004108
HICL Sequence Number Description	PHENAZOPYRIDINE HCL
Brand/Generic	Generic
Proprietary Name	Leader Maximum Strength Urinary Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	PHENAZOPYRIDINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	97.5
Active Ingredient Units	mg/1
Substance Name	PHENAZOPYRIDINE HYDROCHLORIDE
Labeler Name	Cardinal Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0241-01 (70000024101)

Pricing Information	N/A
NDC Package Code	70000-0241-1
Billing NDC	70000024101
Package	1 BLISTER PACK in 1 CARTON (70000-0241-1) / 12 TABLET in 1 BLISTER PACK
Marketing Start Date	2017-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 32624e4e-dd30-49f4-8f3c-baff9f83eb28 Details

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 97.5 mg .

Purpose

Urinary Tract 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

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 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.

Apregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to 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

Corn Starch, Croscarmellose Sodium, hypromellose, Lactose,

Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene glycol,

Polyvinylpyrrolidone, Pregelatinized Starch,

Silicon Dioxide 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER MAXIMUM STRENGTH URINARY PAIN RELIEF

phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0241
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	97.5 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	P97
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0241-1	1 in 1 CARTON	02/01/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/01/2017

Labeler - Cardinal Health (097537435)

Registrant - Reese Pharmaceutical Co (004172052)

Name	Address	ID/FEI	Business Operations
Establishment
Reese Pharmaceutical Co		004172052	relabel(70000-0241) , repack(70000-0241)

Revised: 3/2017

Document Id: 16326945-97af-4f03-ab90-67614ed345a8

Set id: 32624e4e-dd30-49f4-8f3c-baff9f83eb28

Version: 1

Effective Time: 20170303