FDA Label for Leader Urinary Pain Relief
View Indications, Usage & Precautions
Leader 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
Phenazopyridine Hydrochloride 95 mg
Purpose
Urinary Tract Analgesic
Uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Warning
Do not exceed recommended dosage
Ask Doctor Before Use If You Have
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine
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
■ 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.
Keep Out Of The Reach Of Children
in case of an overdose,get medical help or contact a Poison Control Center right away.
Directions
■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Inactive Ingredients
lactose, magnesium silicate, magnesium stearate, microcrystalline
cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch,
croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide.
Package Label.Principal Display Panel
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