FDA Label for Leader Maximum Strength Urinary Pain Relief
View Indications, Usage & Precautions
Leader Maximum Strength Urinary Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.
Active Ingredient (In Each Tablet)
Phenazopyridine Hydrochloride 97.5 mg .
Purpose
Urinary Tract Analgesic
Warnings
Do not exceed recommended dosage
Ask Doctor Before Use If You Have
■ kidney disease
■ allergies to food, preservatives or dyes
■ had a hypersensitive reaction to phenazopyridine
Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
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 Doctor If
■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication
If Pregnant Or Breast Feeding,
Ask a health professional before use.
Apregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.
Keep Out Of Reach Of Children
In case of an overdose, get medical help or contact a Poison Control Center right away.
Use
Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract
infections.
Inactive Ingredients
Corn Starch, Croscarmellose Sodium, hypromellose, Lactose,
Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene glycol,
Polyvinylpyrrolidone, Pregelatinized Starch,
Silicon Dioxide and Sodium Starch Glycolate.
Directions
■ adults and children 12 years and over:
take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ children under 12 years: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
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