MONISTAT MAINTAIN- phenazopyridine hydrochloride tablet

Monistat Maintain by

Drug Labeling and Warnings

Monistat Maintain by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Purpose

Phenazopyridine hydrochloride 99.5 mg………………………………………Urinary analgesic

Use

fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections            

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

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

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 a doctor if

• your symptoms last for more than 2 days
  
• you suspect you are having an adverse reaction to the medication
  
• experience a yellowish tinge of skin or eyes
  
• experience fevers, chills, back pain or bloody urine

If pregnant or breast feeding,

ask a healthcare professional before use.

Keep out of reach of children.

In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Adults and children 12 years of age and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed.
  
• Children under 12 years of age: consult a doctor.

Do not use for more than 2 days (12 tablets) without consulting a doctor.

Other information

• This product may stain contact lenses.
  
• This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests.
  
• 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.
  
• Store at 20º-25º C (68º-77º F) in a dry place and protect from light.

Inactive ingredients

citric acid, artificial & natural cranberry flavor, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silica, starch, and sucralose

Questions?

1-877-666-4782 monistat.com

PRINCIPAL DISPLAY PANEL

Maintain™ from the makers of Monistat® A Trusted Leader In Feminine Care (Logo)

UTI

2-in-1

TEST + PAIN RELIEF KIT

Phenazopyridine HCl 99.5 mg / Urinary analgesic

with CRANBERRY FLAVORED COATING

2 UTI Test Strips | 12 Urinary Pain Relief Tablets

INGREDIENTS AND APPEARANCE

MONISTAT MAINTAIN 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-020
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
CITRIC ACID (UNII: 2968PHW8QP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	7mm
Flavor	CRANBERRY	Imprint Code	X
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-020-12	1 in 1 CARTON	03/01/2025
1		12 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2025

Labeler - Insight Pharmaceuticals LLC (055665422)