URO-PAIN- phenazopyridine hydrochloride tablet 
Rising Pharma Holdings, Inc.

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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URO-PAINTM

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary tract analgesic

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

Warnings

Ask a doctor before use if you have

Do not use 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 breastfeeding, ask a healthcare professional before use. A pregnancy test and consultation with a healthcare 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.

Directions

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

Other Information

Tamper evident: Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.

Questions or comments? Call 1-844-474-7464

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg License Code:
RA/Drug/RAJ.-1750

Issued: 09/2023

Packaging

NDC 57237-331-03

URO-PAINTM

Phenazopyridine Hydrochloride Tablets, 95 mg

Urinary Tract Pain Relief

Phenazopyridine-lable

URO-PAIN 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE95 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorred (Maroon) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code p
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-331-031 in 1 CARTON12/06/2023
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/06/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)

Revised: 12/2023
Document Id: 87a9fce7-4a16-4d25-84da-ee961c430efa
Set id: f0817ef7-c269-4881-81d9-ffc64b404b7e
Version: 1
Effective Time: 20231214
 
Rising Pharma Holdings, Inc.