PHENAZOPYRIDINE HYDROCHLORIDE tablet, coated

PHENAZOPYRIDINE HYDROCHLORIDE by

Drug Labeling and Warnings

PHENAZOPYRIDINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by DirectRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL Unclassified

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Adverse Reactions

Precautions

Dosage and Adminisrtation

Overdosage

Package Label

INGREDIENTS AND APPEARANCE

PHENAZOPYRIDINE HYDROCHLORIDE 
phenazopyridine hydrochloride tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-098(NDC:42937-702)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	200 mg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONES (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown (Reddish-brown)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	702
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-098-10	10 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/09/2015

Labeler - DirectRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DirectRX		079254320	repack(61919-098)