Uricalm

Alva-Amco Pharmacal Companies, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Uricalm Uses
• Warnings
• Do not use if you have
• When using this product
• Stop use and ask a doctor if
• Directions
• Uricalm Other information
• Inactive ingredients

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Phenazopyridine hydrochloride, 99.5 mg

Purpose

Urinary Analgesic

Uricalm Uses

Temporarily relieves

• pain during urination
• burning
• sensation of urgency
• increased frequency
  

associated with urinary tract infections.

Warnings

Do not use if you have

• liver or kidney problems
• allergies to foods, preservatives or dyes
• had a hypersensitive reaction to phenazopyridine hydrochloride.
  

When using this product

• stomach upset may occur; taking this product with or after meals may reduce stomach upset
• you may experience a reddish-orange discoloration of the urine which is a non-harmful temporary effect.
  

Ask a doctor or pharmacist before use if you are taking any other medications.

Stop use and ask a doctor if

• your symptoms do not go away after two days or become worse
• you experience fever, chills, back pain or bloody urine
• you suspect you are having an adverse reaction to this medication.
  

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.  In case of overdose, get medical help or contact a poison control center right away.

Directions

• Read all package directions and warnings before use.
• Use only as directed.
• Do not exceed recommended dosage.
  
• Adults:  Swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum.
• Do not use more than 12 tablets in 2 days.
• Drink 6 to 8 eight glasses of water daily.
• For use by normally healthy adults only.  Persons under 18 years of age should use only as directed by a doctor.
  

Uricalm Other information

Precaution: Carcinogenesis: Long-term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver) .  Although no association between phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.  **Contents sealed:  Each Uricalm dark red colored, round shaped tablet bears the identifying mark "ALVA" and a "1" on the reverse side, and is sealed in a clear plastic blister with with foil backing.  Do not use if seal appears broken or if product contents do not match product description.  This product may stain soft contact lenses.  This product can interfere with laboratory tests including urine, glucose (sugar) and ketones.  You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Cranberry, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, hypromellose, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, sodium starch glycolate, titanium dioxide and triacetin.

Questions?  1-800-792-2582.