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  5. Label Information: Uristat Ultra

FDA Label for Uristat Ultra

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL

Uristat Ultra Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. 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 (In Each Tablet)



Phenazopyridine hydrochloride 99.5 mg


Purpose



Urinary analgesic


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 foods, preservatives, or dyes
  • had a hypersensitive reaction to phenazopyridine

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 care professional before use. 


Keep Out Of Reach Of Children.



In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 


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
  • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
  • 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 20°-25° C (68°-77° F) in a dry place and protect from light.

Inactive Ingredients



croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silica and starch.


Questions?



1-800-344-7239  Uristat.com

©2017 Distributed by Insight Pharmaceuticals LLC
Tarrytown, NY 10591, a Prestige Brands Company


Principal Display Panel



URISTAT® ULTRA

UTI Pain Relief Tablets

Phenazopyridine Hydrochloride  99.5 mg

30 Urinary Pain Relief Tablets

URISTAT® ULTRAUTI Pain Relief TabletsPhenazopyridine Hydrochloride 99.5 mg30 Urinary Pain Relief Tablets - uristat ultra 01

URISTAT® ULTRAUTI Pain Relief TabletsPhenazopyridine Hydrochloride 99.5 mg30 Urinary Pain Relief Tablets - uristat ultra 01

URISTAT® ULTRA

UTI Relief PAK™

Phenazopyridine Hydrochloride  99.5 mg

1 UTI Test Strip and 12 Urinary Pain Relief Tablets


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