Active Ingredients And Purpose
Active Ingredient
Phenazopyridine Hydrochloride 95 mg
Purpose
Urinary Analgesic
Skopko Urinary Pain Relief
- Manufacturer
- Skopko | Reese Pharmaceutical Co
- Effective date
- 2024-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:45:03
Key Label Information#
Uses
Uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Warnings
Warning
Do not exceed recommended dosage
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
If pregnant or breast feeding
ask a health professional before use.
Directions And Dosage
Directions
■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ Children under 12: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Other Label Information
Inactive Ingredients
magnesium stearate,microcrystalline cellulose.May also contain carnauba wax, croscarmellose sodium,hypromellose,lactose,magnesium silicate,maize starch,pharmaceutical glaze,polyethylene glycol,povidone,pregelatinized starch,sodium starch glycolate.
Label Images#
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37012-098-01 | Skopko Urinary Pain Relief | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 37012-098-30 | Skopko Urinary Pain Relief | 30 in 1 CELLO PACK | TABLET | 30 | 4 | |
| 37012-098-50 | Skopko Urinary Pain Relief | 32 in 1 CELLO PACK | TABLET | 32 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PHENAZOPYRIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0EWG668W17 | 1 | |
| PHENAZOPYRIDINE | ACTIVE MOIETY | K2J09EMJ52 | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| MAGNESIUM SILICATE | INACTIVE INGREDIENT | 9B9691B2N9 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 |
Products#
- Skopko Urinary Pain Relief
- PHENAZOPYRIDINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37012-098 | 37012-098-50, 37012-098-01, 37012-098-30 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| PHENAZOPYRIDINE HYDROCHLORIDE | 0EWG668W17 | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| MAGNESIUM SILICATE | 9B9691B2N9 | IACT |
Complete SPL Sections#
Active Ingredient
Phenazopyridine Hydrochloride 95 mg
Purpose
Urinary Analgesic
Uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Warning
Do not exceed recommended dosage
Ask Doctor before use if you have
■ kidney disease ■ allergies to foods, preservatives or dyes ■ had a hypersensitive reaction to Phenazopyridine
When using this product
■ 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
If pregnant or breast feeding
ask a health professional before use.
Keep out of the reach of children
in case of an overdose,get medical help or contact a Poison Control Center right away.
Directions
■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ Children under 12: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Inactive Ingredients
magnesium stearate,microcrystalline cellulose.May also contain carnauba wax, croscarmellose sodium,hypromellose,lactose,magnesium silicate,maize starch,pharmaceutical glaze,polyethylene glycol,povidone,pregelatinized starch,sodium starch glycolate.