Indications and uses
Prompt temporary relief of: pain during urination burning sensation of urgency increased frequency associated with urinary tract infections.
Prompt temporary relief of: pain during urination burning sensation of urgency increased frequency associated with urinary tract infections.
Read all package directions and warnings before use. Use only as directed. Do not exceed recommended dosage. Adults: Swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum. Swallow whole. Do not crush or chew. Do not use more than 12 tablets in 2 days. Drink 6 to 8 eight glasses of water daily. For use by normally healthy adults only. Persons under 18 years of age should ...
Phenazopyridine hydrochloride, 99.5 mg
Urinary Analgesic
Prompt temporary relief of:
associated with urinary tract infections.
Ask a doctor or pharmacist before use if you are taking any other medications.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
WARNING: this product contains a chemical known to the State of California to cause cancer. Precaution: Carcinogenesis: Long-term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver) . Although no association between phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. **Contents sealed: Each URICALM dark red colored, round shaped tablet bears the identifying mark "ALVA" and a "1" on the reverse side, and is sealed in a clear plastic blister with with foil backing. Do not use if seal appears broken or if product contents do not match product description. This product may stain soft contact lenses. This product can interfere with laboratory tests including urine, glucose (sugar) and ketones. You may report serious side effects to the phone number provided under Questions? below.
Carmine, Citric Acid, Cornstarch, Cranberry Extract, Croscarmellose Sodium, FD&C Red No. 40, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silicon Dioxide, Talc, Titanium Dioxide and Triacetin.
Questions? 1-800-792-2582.
Uricalm
199 mg Strong per dose
The Highest Dose of Clinically Proven Phenazopyridine Hydrochloride Available Over the Counter, Plus Cranberry
URICALM provides the maximum non-prescription strength of clinically proven Phenazopyridine Hydrochloride to relieve pain, burning, increased frequency, and sensation of urgency associated with urinary tract infections. Phenazopyridine Hydrochloride is the #1 doctor recommended ingredient for fast relief of UTI pain. Plus, URICALM contains cranberry, which is used extensively by those concerned about urinary tract health.
Active ingredient (in each tablet):Phenazopyridine Hydrochloride 99.5 mg
Purpose: Urinary analgesic
Uses: Prompt temporary relief of
Warnings
Do not use if you have
When using this product
Ask a doctor or pharmacist before use if you are taking any other medications.
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Directions:
Other information: WARNING: This product contains a chemical known to the State of California to cause cancer. Precaution: Carcinogenesis: Long-term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
**Contents sealed: Each URICALM dark red colored, round shaped tablet bears the identifying mark "ALVA" and a "1" on the reverse side, and is sealed in a clear plastic blister with foil backing. Do not use if seal appears broken or if product contents do not match product description. This product may stain soft contact lenses. This product can interfere with laboratory tests including urine, glucose (sugar) and ketones. You may report serious side effects to the phone number provided under Questions? below.
Inactive ingredients:Carmine, citric acid, corn starch, cranberry fruit extract, croscarmellose sodium, FD&C Red No. 40, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, talc, titanium dioxide and triacetin.
Questions? 1-800-792-2582
Uricalm
199 mg de concentración por dosis
Contiene la dosis más alta de phenazopyridine hydrochloride clínicamente comprobado disponible en venta sin receta, además de arándano
URICALM ofrece la dosis más alta de chlorhidrato de fenazopyridina clínicamente comprobado de venta sin receta para aliviar el dolor, el ardor, el aumento en la frequencia y la sensación de necesidad urgente de orinar asociados con las infecciones del tracto urinario. El chlorhidrato de fenazopiridina es el ingrediente N. o 1 recomendado por el médico para el alivio rápido del dolor causado por las infecciones del tracto urinario (UTI, por sus singlas en ingles). Además, URICALM contiene arándano, que es usado ampliamente por quienes se preocupan por la salud del tracto urinario.
Ingrediente activo (in cada tableta): Phenazopyridine hydrochloride 99.5 mg
Propósito: Analgésico urinario
Usos: Alivio rápido y temporal del
Advertencias:
No lo use si tiene
Cuando se use este producto
Consulte con un médico o farmacéutico antes de usarlo si está tomando cualquier otro medicamento.
Interrumpa el uso y consulte con su médico si
Si está embarazada o lactando, consulte con un profesional de la salud antes de usario.
Manténgalo fuera del alcance de los niños. En caso de sobredosis, obtenga ayuda médica o comuníquese de inmediato con un centro de toxicologia.
Indicaciones:
Información adicional: ADVERTENCIA: Este producto contiene una sustancia quimica que en el Estado de California se sabe que causa cáncer. Precaución: Carcinogénesis: La administración a largo plazo del phenazopyridine hydrochloride ha inducido neoplasia en ratas (intestino grueso) y en ratones (hígado). Aunque no ha sido informada una asociación entre el phenazopyridine hydrochloride y la neoplasia en seres humanos, no se han realizado estudios epidemiológicos adecuados sobre esto.
**El contenido está sellado Cada tableta URICALM de color rojo oscuro y redonda lleva la marca identificadora "ALVA" y un "1" en el dorso, y está sellada en un blíster de plástico transperente con un recubrimiento posterior de papel aluminio. No lo use si el sello parece estar roto o si el producto no coincide con la descripción del producto. Este producto puede causar manchas en los lentes de contacto blandos. Este producto puede interferir con las pruebas de laboratorio incluidas orina, glucosa (azúcar) y cetonas. Puede informar efectos secundarios graves al número de teléfono que aparece en la sección ¿Tiene preguntas? a continuación.
Ingredientes inactivos: carmin, ácido cítrico, almidón de maíz, extracto de arándano, croscarmelosa sódica, FD&C Rojo No. 40, FD&C Rojo No. 40 Lake, FD&C Amarillo No. 6 lake, hipromelosa, estearato de magnesio, maltodextrina, celulosa microcristalina, aceite mineral, polietilenglicol, polivinilpirrolidona, almidón pregelatinizado, dióxido de silicio, talco, dióxido de titanio y tracetino.
¿Tiene preguntas? 1-800-792-2582
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094147 | phenazopyridine HCl 99.5 MG Oral Tablet | PSN | 18 |
| 1094149 | Uricalm Maximum Strength 99.5 MG Oral Tablet | PSN | 18 |
| 1094149 | phenazopyridine hydrochloride 99.5 MG Oral Tablet [Uricalm] | SBD | 18 |
| 1094147 | phenazopyridine hydrochloride 99.5 MG Oral Tablet | SCD | 18 |
| 1094147 | phenazopyridine HCl 99.5 MG Oral Tablet | SY | 18 |
| 1094149 | Uricalm 99.5 MG Oral Tablet | SY | 18 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52389-241-01 | UricalmMaximum Strength | 24 in 1 BLISTER PACK | TABLET, FILM COATED | 24 | 18 | |
| 52389-241-02 | UricalmMaximum Strength | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 18 | |
| 52389-241-03 | UricalmMaximum Strength | 36 in 1 BLISTER PACK | TABLET, FILM COATED | 36 | 18 | |
| 52389-241-04 | UricalmMaximum Strength | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | 18 | |
| 52389-241-12 | UricalmMaximum Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 18 | |
| 52389-241-24 | UricalmMaximum Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 18 | |
| 52389-241-28 | UricalmMaximum Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 18 | |
| 52389-241-36 | UricalmMaximum Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 18 | |
| 52389-241-48 | UricalmMaximum Strength | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 18 | |
| 52389-241-48 | UricalmMaximum Strength | 24 in 1 BLISTER PACK | TABLET, FILM COATED | 24 | 18 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52389-241 | URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] | 18 | Current NDC, Legacy NDC, 10 package rows | 20250331_1d94b45c-ee0b-499d-aca2-e8cd8dd490d2.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Phenazopyridine hydrochloride | ACTIVE INGREDIENT | 0EWG668W17 | 5 | |
| Phenazopyridine | ACTIVE MOIETY | K2J09EMJ52 | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 5 | |
| Cranberry | INACTIVE INGREDIENT | 0MVO31Q3QS | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 5 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 5 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 5 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 5 | |
| Mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 5 | |
| Titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 5 | |
| Triacetin | INACTIVE INGREDIENT | XHX3C3X673 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52389-241 | 52389-241-01, 52389-241-24, 52389-241-02, 52389-241-12, 52389-241-03, 52389-241-36, 52389-241-04, 52389-241-28, 52389-241-48 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| Titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| Mineral oil | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| Mineral oil | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | TABLET, FILM COATED / ORAL | 15.12 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | TABLET, FILM COATED / ORAL | 15.12 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| Titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| Mineral oil | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| Mineral oil | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Uricalm Maximum Strength | PHENAZOPYRIDINE HYDOCHLORIDE | Kobayashi Healthcare International, Inc. | 1d94b45c-ee0b-499d-aca2-e8cd8dd490d2 | 2025-03-28 | Warnings | 52389-241-02 52389-241-36 52389-241-04 52389-241-12 52389-241-48 52389-241-24 52389-241-03 52389-241-28 52389-241-01 52389-241 52389024104 52389024124 52389024112 52389024101 52389024136 52389024148 52389024102 52389024103 52389024128 316e93e7-3627-8e6a-e063-6294a90a1d28 1d94b45c-ee0b-499d-aca2-e8cd8dd490d2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.