Monistat Maintain Tablet
FDA Label NDC 63736-020

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Monistat Maintain (NDC 63736-020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding purpose, use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

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

Use

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

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 20°-25° C (68°-77° 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

A Box Of Pain Reliefai-generated Content May Be Incorrect. (Monistat Maintain 63736 020 12 01)

A Box Of Pain Reliefai-generated Content May Be Incorrect. (Monistat Maintain 63736 020 12 01)

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