FDA Label for Leader Azo Tabs Urinary Tract Analgesic
View Indications, Usage & Precautions
Leader Azo Tabs Urinary Tract Analgesic 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.
Otc - Active Ingredient
Phenazopyridine Hydrochloride 95 mg
Otc - Purpose
Purpose;
Urinary Analgesic
Indications & Usage
Uses
fast relief from urinary pain,burning,urgency and frequency associated with
urinary tract infections.
Warnings
Do not exceed recommended dosage
Otc - Ask Doctor
Ask a Doctor before use if you have
kidney disease,
allergies to foods,preservatives or dyes,
had a hypersensitive reaction to phenazopyridine.
Otc - When Using
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.
Otc - Stop Use
Stop use and ask a doctor if
if your symptoms last for more than 2 days
you suspect you are having an adverse reaction
to the medication.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - 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 right away.
Dosage & Administration
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 Ingredient
magnesium stearate,microcrystalline cellulose.May also contain carnauba wax,
croscarmellose sodium,hypromellose,lactose,magnesium silicate,maize starch,pharmaceutical
glaze,polyethylene glycol,povidone,pregelatinized starch,sodium starch glycolate.
Package Label.Principal Display Panel
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