AZO URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [I-HEALTH, INC.]

AZO URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [I-HEALTH, INC.]
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NDC 49973-247-12, 49973-247-24, 49973-247-96
Set ID b4874fe2-d98b-4b5c-baad-d75070947842
Category HUMAN OTC DRUG LABEL
Packager i-Health, Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 99.5 mg

  • 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

    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 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 doctor if

    • your symptoms last for more than 2 days
    • you suspect you are having an adverse reaction to the medication.

    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. 

    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.

  • SPL UNCLASSIFIED SECTION

    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 

  • 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

  • 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). 

    UPR 12UPR 24UPR English InsertUPR Spanish InsertUPR 96UPR 96 English InsertUPR 96 Spanish Insert

  • INGREDIENTS AND APPEARANCE
    AZO URINARY PAIN RELIEF  MAXIMUM STRENGTH
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-247
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorred (Maroon) Scoreno score
    ShapeCAPSULESize9mm
    FlavorImprint Code 99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49973-247-126 in 1 BOX07/02/2018
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49973-247-2412 in 1 BOX07/02/2018
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:49973-247-9648 in 1 BOX02/22/2019
    32 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/02/2018
    Labeler - i-Health, Inc. (061427694)

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