PHENAZOPYRIDINE HYDROCHLORIDE 97.5MG- phenazopyridine hydrochloride tablet

Phenazopyridine Hydrochloride 97.5mg by

Drug Labeling and Warnings

Phenazopyridine Hydrochloride 97.5mg by is a Otc medication manufactured, distributed, or labeled by AMOL PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 97.5 mg

Purpose

Urinary analgesic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of an overdose, get medical help or contact poison Control Center right away.

INDICATIONS & USAGE

Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

Warnings Pleae read insert for important precautions

Ask a doctor before use if you have  kidney disease  allergies to foods, preservatives or dyes  had a hypersensitive reaction to Phenazopyridine Hydrochloride. 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 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 breastfeeding, ask health professional before use.

DOSAGE & ADMINISTRATION

Directions  Adults and children 12 years and older. 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 doctor  Children under 12: Do not use without consulting doctor.

INACTIVE INGREDIENT

Inactive ingredients microcrystalline cellulose , pregelatinized corn starch, hypromellose, povidone, croscarmellose sodium, polyethylene glycol, carnauba wax and magnesium stearate. May also contain corn starch.

STORAGE AND HANDLING

Other information  This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests  This product may stain soft contact lenses and other items if handled after touching tablets.  Store at room temperature (59 - 86F) in a dry place and protect from light  Tamper evident: tablets sealed in blisters. Do not use if blister foil is open or damaged.

Packaging

INGREDIENTS AND APPEARANCE

PHENAZOPYRIDINE HYDROCHLORIDE 97.5MG 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63189-002
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	brown (Dark brown)	Score	no score
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	WX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63189-002-12	1 in 1 CARTON	03/16/2015	03/31/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63189-002-24	1 in 1 CARTON	03/16/2015	03/31/2021
2		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/16/2015	03/31/2021

Labeler - AMOL PHARMACEUTICALS PRIVATE LIMITED (676245969)

Establishment
Name	Address	ID/FEI	Business Operations
AMOL PHARMACEUTICALS PRIVATE LIMITED		676245969	manufacture(63189-002)