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  5. Label Information: Azo Urinary Pain Relief Maximum Strength

FDA Label for Azo Urinary Pain Relief Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. OTHER
    14. SPL PATIENT PACKAGE INSERT
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Azo Urinary Pain Relief Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product I-health, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg


Otc - Purpose



Purpose

Urinary tract analgesic


Indications & Usage



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


Warnings



Warnings

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

Otc - Do Not Use



Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.


Otc - When Using



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.

Otc - Stop Use



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.

Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a professional before use.  A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. 


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



Directions

  • Adults and children 12 years and older: 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 without consulting a doctor.

Other Safety Information



Other Information

  • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
  • This product may stain soft contact lenses and other items if handled after touching tablets
  • Store at room temperature (59-86 F) in a dry place and protect from light.                                                                                      

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


Inactive Ingredient



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


Other



Distributed by i-Health, Inc., 55 Sebethe Drive, Cromwell, CT 06416

Made in India. Size and color of tablets may vary. 

For questions, concerns, or to report an adverse event, call (800) 722-3476

AZO Urinary Pain Relief® and OWN YOUR DAY™ are trademarks of DSM.

Información y instrucciones en Español adjuntas

visit www.azoproducts.com to read customer reviews 


Spl Patient Package Insert



AZO 

Urinary Pain Relief® 

MAXIMUM STRENGTH 

Urinary Pain Relief Tablets 

Active ingredient: Each analgesic tablet contains Phenazopyridine Hydrochloride 99.5 mg. 

Fast relief of urinary discomfort including common urinary tract infection symptoms: Urinary pain, burning, urgency and frequency. 

URINARY TRACT INFECTION (UTI)

Symptoms of urinary discomfort may indicate a urinary tract infection.  If you experience symptoms such as urinary pain, burning, urgency and frequency, you need to call your doctor to get diagnosed and obtain a prescription to treat the infection. While you wait to get to the doctor and for the prescription to begin to work, you can get fast, symptomatic relief with AZO Urinary Pain Relief Maximum Strength. 

WARNINGS 

Ask a doctor before use if you have:

  • liver or kidney trouble 
  • allergies to foods, preservatives or dyes 
  • had a hypersensative reaction to Phenazopyridine Hydrochloride

    • 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 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 using ths product and ask a doctor if you think you may be having an adverse reaction to the medication or if your symptoms last for more than two days. 

      If you are pregnant or breastfeeding, ask a healthcare professional before you use this product.  A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. 

      Keep this medication 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 years and older: Take two (2) tablets three (3) times daily for up to two days.  Take with a full glass of water, with or after meals as needed. Do not use for more than two days (12 tablets) without consulting a doctor. 

      Children under age 12: do not use without consulting a doctor. 

      OTHER INFORMATION & PRECAUTIONS

      • This product can interfere with laboratory tests including urine, glucose (sugar) and keytones. 
      • This product may stain soft contact lenses and other items if handled after touching tablets. 
      • Size and color of tablets may vary. 
      • Carcinogenesis: Long-term administration of Phenazopyridine Hydrochloride 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. 
      • Storage: Store at room temperature (59° - 86°F) in a dry place and protect from light. 
      • Tamper Evident: Product is sealed within blisters. Do not use if any part of the blister is torn, open or damanged.

        • For questions, concerns, or to report an adverse event, please call (800) 722-3476 or visit www.azoproducts.com 

        AZO

        Urinary Pain Relief®

        MAXIMUM STRENGTH 

        Alivio rápido para el dolor de las vías urinarias

        Ingrediente activo: Cada tableta de analgésico contiene 99.5 mg

        de hidrocloruro de fenazopiridina.

        Alivio rápido de la incomodidad en las vías urinarias que incluye

        los síntomas comunes de infección en las vías urinarias: dolor al

        orinar, ardor, urgencia y frecuencia.

        INFECCIÓN DE LAS VÍAS URINARIAS

        Los síntomas de incomodidad en las vías urinarias pueden

        indicar la presencia de una infección. Si tiene síntomas como

        dolor, ardor, urgencia y frecuencia, necesita llamar a su médico

        para recibir un diagnóstico y que le dé una receta para tratar la

        infección. Mientras espera para ver al doctor y para que el

        medicamento que le recete comience a funcionar, puede

        obtener un alivio rápido de sus síntomas con AZO Urinary Pain

        Relief® Maximum Strength.

        ADVERTENCIAS

        Consulte a su médico antes de usar este producto si:

        • tiene problemas renales o hepáticos.

        • tiene alergias a alimentos, conservadores o tintes.

        • ha tenido una reacción alérgica a el hidrocloruro de

        fenazopiridina.

        No usar: si tiene una deficiencia de glucosa-6-fosfato

        deshidrogenasa (G6PD), a menos que su médico lo apruebe.

        Al usar este producto:

        • puede sentir malestar estomacal. Tómelo durante o después

        de las comidas para ayudar a disminuir el malestar.

        • la orina adquiere un color anaranjado rojizo.

        Esto no es dañino, pero debe tener cuidado para evitar

        manchar a ropa u otros artículos.

        Deje de usar este producto y consulte a su médico si piensa

        que puede estar teniendo una reacción adversa al medicamento

        o si sus síntomas duran más de dos días.

        Si usted está embarazada o lactando, consulte a un profesional

        médico antes de usar este producto. Se recomienda una prueba

        de embarazo y una consulta con un profesional médico si se

        confirma un embarazo antes de usar el producto.

        Mantenga este medicamento fuera del alcance de los niños.

        En caso de una sobredosis, consiga atención médica o

        comuníquese con un centro de control de envenenamiento de

        inmediato.

        INSTRUCCIONES

        Adultos y niños mayores de 12 años: tome dos (2) tabletas tres

        (3) veces al día hasta dos días. Tome con un vaso de agua, durante

        o después de las comidas, según sea necesario. No lo utilice

        durante más de 2 días (12 tabletas) sin consultar a un médico.

        Niños menores de 12 años: no se utilice sin consultar a un médico.

        OTRA INFORMACIÓN y PRECAUCIONES

        • Este producto puede interferir con los análisis de

        laboratorio, incluso los análisis de orina, glucosa (azúcar)

        y cetonas.

        • Este producto puede manchar los lentes de contacto blandos

        y otros artículos si los manipula después de tocar las tabletas.

        • El tamaño y el color de las tabletas puede variar.

        • Carcinogénesis: la administración a largo plazo del

        hidrocloruro de fenazopiridina ha inducido neoplasia en

        ratas (intestino grueso) y ratones (hígado). Aunque no se ha

        informado acerca de ningún caso que relacione el

        hidrocloruro de fenazopiridina con la neoplasia en

        humanos, no se han efectuado estudios epidemiológicos

        adecuados al respecto.

        • Almacenaje: almacénese a temperatura ambiental

        (15° a 30°C) en un sitio seco, y protéjase de la luz.

        • Evidencia de alteraciones: el producto viene sellado en

        blísteres. No lo use si alguna parte del blíster está rota,

        abierta o dañada.

        Para preguntas, dudas o para informar acerca de una reacción adversa,

        llame al (800) 722-3476 o visite www.azoproducts.com


Package Label.Principal Display Panel



RELIEF That's Fast 

AZO

Urinary Pain Relief®

MAXIMUM STRENGTH

  • STRONGEST UTI PAIN RELIEVER AVAILABLE+
  • EVEN HIGHER DOSE TO RELEIVE PAIN, BURNING & URGENCY+
  • TARGETS THE SOURCE OF PAIN

    • #1 MOST TRUSTED BRAND*

    __ TABLETS

    99.5 mg

    Phenazopyridine Hydrochloride  

    +Among AZO Urinary Pain Relief® products. 

    * #1 Most Trusted Brand based on Total AZO Brand Nielsen data through 1/20/18 and the 2017 Pharmacy Times Survey (Urinary Pain Relief and Cranberry Supplement categories). 


* Please review the disclaimer below.