URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet 
YYBA CORP

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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YYBA (as PLD) - WELMATE - URINARY PAIN RELIEF (73581-909)

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

Purpose

Urinary Tract Analgesic

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

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

Please 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

Do not useif 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 a doctor if

■ your symptoms last for more than 2 days

■ you suspect you are having an adverse reaction to the medication

■ Long-term adminitration of phenazopyridine hydrochloride has induced neoplasia in rats (large instestine) andmice (liver). Although no association between phenazopyridine hydrochloride and human enoplasia has beeen reported, adequate epidemiological studies along these lines have not been conducted.

If pregnant or breast-feeding,ask a health professional before use. A pregnancy test and consultation with a health 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 (1-800-222-1222) right away.

■ This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests

■ This product may stain contact lenses and other items if handled after touching tablets

■ long term administration of phenazopyridine HCI has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted

■ Store at room temperature 15°-30°C (59°-86°F) in a dry place and protect from light

Adults and children 12 years of age and over: 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 wihout consulting a doctor

pregelatinized starch, microcrystalline cellulose, maize (corn) starch, povidone, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, hydroxypropyl methylcellulose, polyethylene glycol

call toll-free 1-845-547-2667

Size and color of tablets may vary.

*This product is not manufactured or distributed by the owner of the registered trademark AZO Urinary Pain Relief®.

Distributed by: Wellspring

Airmont, NY 10952, USA

Urinary Pain Relief - FrontUrinary Pain Relief - Back

URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-909
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73581-909-7272 in 1 BOTTLE; Type 0: Not a Combination Product09/10/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/10/2020
Labeler - YYBA CORP (006339772)

Revised: 1/2024
Document Id: 0e137aa6-12f6-9487-e063-6294a90a4dd9
Set id: ad034f45-2852-f3c9-e053-2a95a90a38cb
Version: 3
Effective Time: 20240103
 
YYBA CORP