LEADER MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet
Cardinal Health
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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DRUG FACTS
Use
fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections
Warnings
Do not exceed recommended dosage
Ask a 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 a doctor if
■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication
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
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 HCl 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 room temperature 15°-30°C (59°-86°F) in a dry place and protect from light.
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.
*This product is not manufactured or distributed by i-Health, Inc., distributor of AZO Urinary Pain Relief™ Maximum Strength.
All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
Distributed By:
Cardinal Health
Dublin, Ohio 43017
CIN 5087333
Rev. 5/15 AMAXLDR
Principal Display Panel
NDC 49781-139-12
LEADER®
Compare to
AZO Urinary Pain Relief™
Maximum Strength*
active ingredient
MAXIMUM STRENGTH
Urinary
Pain Relief
Phenazopyridine HCl 97.5 mg
Fast Relief for Urinary Pain
Prompt Relief of Urinary Pain, Burning & Urgency
More Active Ingredient for
Maximum Relief
SATSIFACTION GUARANTEED
12 TABLETS
| LEADER MAXIMUM STRENGTH URINARY PAIN RELIEF
phenazopyridine hydrochloride tablet |
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| Labeler - Cardinal Health (097537435) |