URICALM MAXIMUM STRENGTH- phenazopyridine hydochloride tablet, film coated 
Alva-Amco Pharmacal Companies, 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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Uricalm

Active ingredient (in each tablet)

Phenazopyridine hydrochloride, 99.5 mg

Purpose

Urinary Analgesic

Uses

Prompt temporary relief of:

associated with urinary tract infections.

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 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.

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 MAX 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.

Inactive ingredients

Cornstarch, Cranberry Fruit Powder, Croscarmellose Sodium, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silicon Dioxide, Talc, Titanium Dioxide and Triacetin.

Questions?  1-800-792-2582.

Product Insert

DOCTOR RECOMMENDED

Uricalm Max

199 mg Strong per dose

The Highest Dose of Clinically Proven Phenazopyridine Hydrochloride Available Over the Counter, Plus Cranberry

URICALM MAX 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. URICALM MAX has 99.5 mg of Phenazopyridine Hydrochloride per tablet - no other OTC brand contains more. Plus, URICALM MAX 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 MAX 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:Corn starch, cranberry fruit powder, croscarmellose sodium, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, talc, titanium dioxide and triacetin.

Questions? 1-800-792-2582

www.URICALM.com

RECOMENDADO POR MÉDICOS

Uricalm Max

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 MAX ofrece la dosis más alta de phenazopyridine hydrochloride 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. URICALM MAX tiene 99.5 mg de phenazopyridine hydrochloride por tableta; ninguna otra marca de venta sin receta contiene más. Además, URICALM MAX 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 MAX 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: Almidón de maíz, polvo de la fruta de arándano, croscarmelosa sódica, FD&C Rojo No. 40 Lake, FD&C Amarillo No. 6 lake, hipromelosa, estearato de magnesio, celulosa microcristalina, aceite mineral, polietilenglicol, polivinilpirrolidona, almidón pregelatinizado, dióxido de silicio, talco, dióxido de titanio y tracetino.

¿Tiene preguntas? 1-800-792-2582

www.URICALM.com

UricalmPDP

URICALM  MAXIMUM STRENGTH
phenazopyridine hydochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-241
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
CRANBERRY (UNII: 0MVO31Q3QS)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code ALVA;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-241-241 in 1 CARTON04/29/2008
1NDC:52389-241-0124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:52389-241-121 in 1 CARTON08/01/200912/31/2011
2NDC:52389-241-0212 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:52389-241-361 in 1 CARTON07/15/201206/15/2013
3NDC:52389-241-0336 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:52389-241-281 in 1 CARTON02/20/2014
4NDC:52389-241-0428 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:52389-241-482 in 1 CARTON10/18/2021
524 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/29/2008
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 11/2023
Document Id: 0b4d3ef3-c486-a14b-e063-6294a90abadf
Set id: 1d94b45c-ee0b-499d-aca2-e8cd8dd490d2
Version: 13
Effective Time: 20231129
 
Alva-Amco Pharmacal Companies, Inc.