OTC Medication Information: AZO Urinary Pain Relief Maximum Strength

AZO URINARY PAIN RELIEF MAXIMUM STRENGTH- phenazopyridine hydrochloride tablet
i-Health, 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.

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

Purpose

Urinary tract analgesic

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

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.

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

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

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 año s: 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

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 12
(click image for full-size original)
UPR 24
(click image for full-size original)
UPR English Insert
(click image for full-size original)
UPR Spanish Insert
(click image for full-size original)
UPR 96
(click image for full-size original)
UPR 96 English Insert
(click image for full-size original)
UPR 96 Spanish Insert
(click image for full-size original)

AZO URINARY PAIN RELIEF MAXIMUM STRENGTH
phenazopyridine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49973-247
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenazopyridine Hydrochloride (Phenazopyridine ) Phenazopyridine Hydrochloride 99.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
HYPROMELLOSES
POVIDONE
CROSCARMELLOSE SODIUM
POLYETHYLENE GLYCOL, UNSPECIFIED
CARNAUBA WAX
MAGNESIUM STEARATE
Product Characteristics
Color red (Maroon) Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code 99
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49973-247-12 6 BLISTER PACK12 BLISTER PACK48 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 NDC:49973-247-24 6 BLISTER PACK12 BLISTER PACK48 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 NDC:49973-247-96 6 BLISTER PACK12 BLISTER PACK48 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 2 TABLET in 1 BLISTER PACK This package is contained within a BOX (49973-247-12) and a BOX (49973-247-24) and a BOX (49973-247-96)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/02/2018
Labeler — i-Health, Inc. (061427694)

Revised: 09/2019 i-Health, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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