CYSTEX MAX UTI PAIN RELIEF- phenazopyridine hydrochloride tablet

Cystex Max UTI Pain Relief by

Drug Labeling and Warnings

Cystex Max UTI Pain Relief by is a Otc medication manufactured, distributed, or labeled by Clarion Brands, LLC, Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenazopyridine hydrochloride 99.5 mg

Purpose

Urinary tract analgesic

INDICATIONS & 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.

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.
  

Do not use

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

Ask a doctor before use if you have

• kidney disease
  
• allergies to foods, preservatives or dyes
  
• had a hypersensitive reaction to phenazopyridine hydrochloride
  

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
  

PREGNANCY OR BREAST FEEDING

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.

KEEP OUT OF REACH OF CHILDREN

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

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

Questions

call 1-844-297-8394

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 Pain at 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.com or call
844-297-8394

Distributed by: Cystex LLC
811 Broad Street, Suite 600
Chattanooga, TN 37402  ©2024
*without a prescription

INGREDIENTS AND APPEARANCE

CYSTEX MAX UTI PAIN RELIEF 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69693-514
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Phenazopyridine Hydrochloride (UNII: 0EWG668W17) (Phenazopyridine - UNII:K2J09EMJ52)	Phenazopyridine Hydrochloride	99.5 mg

Inactive Ingredients
Ingredient Name	Strength
Starch, Corn (UNII: O8232NY3SJ)
Croscarmellose Sodium (UNII: M28OL1HH48)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Lactose, Unspecified Form (UNII: J2B2A4N98G)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Povidone, Unspecified (UNII: FZ989GH94E)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Starch Glycolate Type A (UNII: H8AV0SQX4D)
Talc (UNII: 7SEV7J4R1U)
Triacetin (UNII: XHX3C3X673)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CYSTEX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69693-514-24	1 in 1 CARTON	08/02/2024
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/02/2024

Labeler - Clarion Brands, LLC (079742703)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(69693-514)