FDA Label for Monistat Maintain
View Indications, Usage & Precautions
Monistat Maintain Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.
