PHENAZOPYRIDINE HYDROCHLORIDE 97.5MG- phenazopyridine hydrochloride tablet 
AMOL PHARMACEUTICALS PRIVATE LIMITED

Disclaimer: 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.

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Phenazopyridine Hydrochloride Tablets 97.5mg

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 97.5 mg

Purpose

Urinary analgesic

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

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.

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

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

Phenazo12

Phenazo24

PHENAZOPYRIDINE HYDROCHLORIDE 97.5MG 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63189-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE97.5 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorbrown (Dark brown) Scoreno score
ShapeCAPSULESize9mm
FlavorImprint Code WX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63189-002-121 in 1 CARTON03/16/201503/31/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63189-002-241 in 1 CARTON03/16/201503/31/2021
224 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/16/201503/31/2021
Labeler - AMOL PHARMACEUTICALS PRIVATE LIMITED (676245969)
Establishment
NameAddressID/FEIBusiness Operations
AMOL PHARMACEUTICALS PRIVATE LIMITED676245969manufacture(63189-002)

Revised: 8/2018
 
AMOL PHARMACEUTICALS PRIVATE LIMITED