Phenazopyridine Hydrochloride by Cardinal Health 5479-Cardinal
Phenazopyridine Hydrochloride by
Drug Labeling and Warnings
Phenazopyridine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
PHENAZOPYRIDINE HYDROCHLORIDE- phenazopyridine hydrochloride tablet, film coated
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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5479-Cardinal
Use
relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Do not exceed recommended dosage
Ask a doctor before use if you have
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine Hydrochloride
Do not use 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 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 and other items if handled after touching tablets
■ This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
■ Long term administration of phenazopyridine HCI 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.
carnauba wax, corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch and silica.
CAUTION: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED.
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
WARNING This product can expose you to Phenazopyridine Hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov
*This product is not manufactured or distributed by i-Health, Inc., owner of the registered trademark AZO Urinary Pain Relief®.
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979
2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.
LEADER TM
NDC: 70000-0031-1
Urinary Pain Relief
Phenazophyridine Hydrochloride Tablets, 95 ng
Urinary Tract Analgesic
COMPARE TO AZO URINARY PAIN RELIEF® active ingredient*
100% Money Back Guarantee
30 Tablets individually sealed
| PHENAZOPYRIDINE HYDROCHLORIDE
phenazopyridine hydrochloride tablet, film coated |
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| Labeler - Cardinal Health (097537435) |