RxNorm Names

Review RxNorm Normal Forms

URINARY PAIN RELIEF (phenazopyridine hydrochloride) tablet
[Mckesson (Sunmark)]

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http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b73f9b1f-aa6f-468f-880e-a7fa4bcf930b

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		unapproved drug other

NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary analgesic

Uses

for temporary relief of

urinary pain
burning
urgency
frequency associated with urinary tract infection

Warnings

Do not use

for more than 2 days without consulting a doctor.

Ask a doctor before use if you have

kidney disease
hepatic or renal problems
allergies to foods, preservatives, or dyes
previously exhibited hypersensitivity to Phenazopyridine.

Stop use and ask a doctor if

symptoms persists for more than 2 days
yellowish tinge of skin or sclera occurs

When using this product

stomach upset may occur
a harmless reddish- orange color will be produced in the urine and may stain fabric
staining of the contact lenses may also occur

If pregnant or breast- feeding

Ask a health care professional before use.

Keep out of reach of children.

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

Directions

adults and children 12 years of age and over: take 2 tablets 3 times per day with or after meals as needed. Take with a full glass of water.
children under 12 years of age: consult a doctor

Other information

store at controlled room temperature 15°-30°C (59°-86°F)
do not use if cellophane packet is torn or open
*This product is not manufactured or distributed by Amerifit Brands, Inc., the distributor of AZO Standard®.

Inactive ingredients

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

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Compare to AZO STANDARD® active ingredient*

Urinary Pain Relief

Phenazopyridine HCl

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Another quality product Distributed by McKesson

One post street, San Franciso, CA 94104

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Please visit us at www.sunmarkbrand.com

Phenazopyridine Hydrochloride 95 mg

URINARY PAIN RELIEF
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-364(NDC:10267-0064)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE)	PHENAZOPYRIDINE HYDROCHLORIDE	95 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE
MAGNESIUM SILICATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A CORN

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	CPC64
Contains

Packaging
#	Item Code	Package Description
1	NDC:49348-364-44	1 in 1 CARTON
1		30 in 1 CELLO PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		07/09/2010

Labeler - Mckesson (Sunmark) (177667227)

Revised: 10/2012

Document Id: 18a65eb2-f8ff-48ea-b3c0-3b74fe81832c

Set id: b73f9b1f-aa6f-468f-880e-a7fa4bcf930b

Version: 1

Effective Time: 20121003

Mckesson (Sunmark)

Daily Med

Current Medication Information

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