Monistat Maintain 63736-020-12

Monistat Maintain 63736-020-12
SPL v2
SPL
SPL Set ID d1e563fc-5a91-4867-8177-93102bd24fe4
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (99.5 mg)
Inactive Ingredients
Citric Acid Croscarmellose Sodium Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Mineral Oil Polyethylene Glycol, Unspecified Povidone Silicon Dioxide Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: X Shape: round Color: brown Size: 7 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-03-01

Description

Drug Facts

Purpose

Urinary analgesic


Medication Information

Purpose

Urinary analgesic

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

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.

Questions?

1-877-666-4782 monistat.com

Active Ingredient

Phenazopyridine hydrochloride 99.5 mg

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.

WARNING: This product can expose you to chemicals including phenazopyridine hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

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

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

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.

Ask A Doctor Before Use If You Have
  • kidney disease

  • allergies to foods, preservatives, or dyes

  • had a hypersensitive reaction to phenazopyridine

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Urinary analgesic

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.

Questions?

1-877-666-4782 monistat.com

Active Ingredient (Active ingredient)

Phenazopyridine hydrochloride 99.5 mg

Other Information (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.

WARNING: This product can expose you to chemicals including phenazopyridine hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

Inactive Ingredients (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

Principal Display Panel (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

When Using This Product (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 (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, (If pregnant or breast feeding,)

ask a healthcare professional before use.

Keep Out of Reach of Children. (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.

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

Advanced Ingredient Data


Raw Label Data

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