Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID a4d34c20-62af-4a3c-ad2c-046ba08d1ef6
Route
ORAL
Published
Effective Date 2024-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (99.5 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Talc Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: CYSTEX Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-02

Description

Phenazopyridine hydrochloride 99.5 mg

Purpose

Urinary tract analgesic


Medication Information

Indications and Usage

Use  fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days without consulting a doctor; see Directions.

Purpose

Urinary tract analgesic

Description

Phenazopyridine hydrochloride 99.5 mg

Section 53414-9

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

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

Warnings
  • Do not exceed recommended dosage

  • 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.

Questions

call 1-844-297-8394

Directions

Adults and children 12 years of age and older:take 2 tablets 3 times a day with a full glass of water or after meals as needed

  • children under 12 years:
  • ask a doctor
Do Not Use

if you have Glucose-6-Phosphare Dehydrogenase (G6PD) deficiency unless approved by your doctor

Active Ingredient

Phenazopyridine hydrochloride 99.5 mg

Other Information
  • WARNING: This product contains Phenazopyridine Hydrochloride, known to the state of California to cause cancer.

  • 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°F-86°F (15°C-30°C) 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

corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc, triacetin

Principal Display Panel

MAX STRENGTH



Cystex ®

Urinary Health



Phenazopyridine Hydrochloride 99.5 mg



MAX UTI PAIN RELIEF



FAST-ACTING UTI PAIN RELIEF



Strongest UTI Pain Relief Available

for Fast-Acting Relief of Pain & Burning *



Relief of Pain, Burning, & Urgency



√  Targets Painat the Source of the UTI



STARTS

WORKING


IN AS LITTLE AS 

15 MINUTES



Cystex is not intended to replace a doctor's care.



24 Tablets



TAMPER EVIDENT: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED.



1000284



REV XX/XX REESECODE



For more information on

Cystex Max Strength UTI Pain

Relief or other products, please

visit www.cystex.comor call

844-297-8394



Distributed by: Cystex LLC

811 Broad Street, Suite 600

Chattanooga, TN 37402  ©2024

*without a prescription

When Using This Product
  • do not exceed recommended dosage

  • 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.

  • do not use for more than 2 days (12 tablets) without consulting a doctor

Stop Use and Ask A Doctor If
  • your symptoms last for more than 2 days
  • you suspect you are having an adverse reaction to the medication

Ask A Doctor Before Use If You Have
  • kidney disease

  • allergies to foods, preservatives or dyes

  • had a hypersensitive reaction to phenazopyridine hydrochloride


Structured Label Content

Indications and Usage (34067-9)

Use  fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days without consulting a doctor; see Directions.

Section 53414-9 (53414-9)

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

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

Purpose

Urinary tract analgesic

Warnings
  • Do not exceed recommended dosage

  • 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.

Questions

call 1-844-297-8394

Directions

Adults and children 12 years of age and older:take 2 tablets 3 times a day with a full glass of water or after meals as needed

  • children under 12 years:
  • ask a doctor
Do Not Use (Do not use)

if you have Glucose-6-Phosphare Dehydrogenase (G6PD) deficiency unless approved by your doctor

Active Ingredient (Active ingredient)

Phenazopyridine hydrochloride 99.5 mg

Other Information (Other information)
  • WARNING: This product contains Phenazopyridine Hydrochloride, known to the state of California to cause cancer.

  • 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°F-86°F (15°C-30°C) 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 (Inactive ingredients)

corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc, triacetin

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MAX STRENGTH



Cystex ®

Urinary Health



Phenazopyridine Hydrochloride 99.5 mg



MAX UTI PAIN RELIEF



FAST-ACTING UTI PAIN RELIEF



Strongest UTI Pain Relief Available

for Fast-Acting Relief of Pain & Burning *



Relief of Pain, Burning, & Urgency



√  Targets Painat the Source of the UTI



STARTS

WORKING


IN AS LITTLE AS 

15 MINUTES



Cystex is not intended to replace a doctor's care.



24 Tablets



TAMPER EVIDENT: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED.



1000284



REV XX/XX REESECODE



For more information on

Cystex Max Strength UTI Pain

Relief or other products, please

visit www.cystex.comor call

844-297-8394



Distributed by: Cystex LLC

811 Broad Street, Suite 600

Chattanooga, TN 37402  ©2024

*without a prescription

When Using This Product (When using this product)
  • do not exceed recommended dosage

  • 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.

  • do not use for more than 2 days (12 tablets) without consulting a doctor

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • your symptoms last for more than 2 days
  • you suspect you are having an adverse reaction to the medication

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney disease

  • allergies to foods, preservatives or dyes

  • had a hypersensitive reaction to phenazopyridine hydrochloride


Advanced Ingredient Data


Raw Label Data

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