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Uristat_pakinsert

URISTAT • If your symptoms persist, are severe, or you experience fever, chills, back pain or bloody urine see your doctor promptly. You may have a serious condition that requires different treatment.
• Phenazopyridine HCI may cause gastrointestinal upset in some people. Take with or after meals to reduce gastric upset and Relief PAK
discontinue use if symptoms occur.
• This product may stain soft contact lenses.
Keep this and all drugs out of reach of children and do not admin-
ister to children under the age of 12 unless directed by a physician. • In case of accidental overdose, seek professional assistance or Step 1: Test for infection with the URISTAT™ UTI Test Strip.
contact a poison control center immediately. Step 2: Temporarily relieve your pain with URISTAT® pain relief tablets.
• Carcinogenesis: Long-term administration of phenazopyridine HCI TO MAXIMIZE THE ACCURACY OF THE UTI TEST STRIP, PAIN has induced neoplasia in rats (large intestine) and mice (liver). RELIEF TABLETS SHOULD NOT BE TAKEN PRIOR TO TESTING.
Although no association between phenazopyridine HCI and human neoplasia has been reported, adequate epidemiological studies along URISTAT®
these lines have not been conducted. Nonprescription temporary pain relief - from the makers of MONISTAT® products. URISTAT® contains phenazopyridine HCI, the #1 doctor recommended medication used to treat pain or discomfort experienced WHAT IS URINARY DISCOMFORT?
while urinating. Simply put, urinary discomfort is pain during urination. Often described as a burning sensation, the pain can be severe and may affect the area • Fast temporary relief of pain, burning, urgency and frequency of under the stomach (the abdomen) or the lower back. Most people also feel a strong need to urinate more often or more urgently than usual, • Easy-to-swallow tablet form even though very little liquid is finally released.
• Brought to you by the makers of MONISTAT® - the #1 recommenda- COMMON CAUSES OF A UTI
tion of doctors and the #1 choice of women for OTC vaginal yeast UTIs typically occur as a result of bacteria entering your urinary system infection treatments.
through the urethra. Oftentimes, the bacteria are gastrointestinal and HOW TO USE URISTAT®
originate in the anus. The bacteria may travel to and multiply in the • Adults and children 12 years of age and over: take 2 tablets,
bladder, and if the infection is not treated, it can spread to the kidneys.
3 times daily with a full glass of water, with or after meals as needed There are certain factors, however, that can make you more susceptible • Children under 12 years of age: consult a doctor
to a UTI. These include being a woman; engaging in sexual activity; and • Do not use for more than 2 days (12 tablets) without consulting
using certain types of birth control, such as diaphragms or spermicidal • Do not take if you have previously exhibited hypersensitivity to HOW TO HELP AVOID UTIs AND URINARY DISCOMFORT
phenazopyridine HCI or if you have kidney trouble. Remember UTIs are not 100% preventable, but you can take some steps to that advanced age is associated with declining kidney function. decrease your chances of infection. Some of these precautions include Discontinue therapy if you experience a yellowish tinge of the skin drinking plenty of water, wiping front to back after going to the bathroom, or eyes. This may indicate accumulation due to impaired kidney and urinating after sex. or liver function.
• As with any drug, if you are pregnant or nursing a baby, seek the
advice of a health professional before using the product. If you have any questions about URISTAT™ products, please
contact Customer Service at 1-800-344-7239 or visit our website
at uristat.com. For medical advice or questions, consult a doctor
or health professional.
INSIGHT Pharmaceuticals, LLC.
Langhorne, PA 19047-1749 2011 Turn over for instructions on test strips MEANING OF RESULTS
Meaning of Your Result URISTAT Negative (-) Negative (-) No sign of UTI detected. Consult a physician or health professional if you still have symptoms. There are some cases of UTI that the test may Relief PAK
Results suggest a sign of UTI. Consult a TEST STRIPS
physician or health professional immediately. Test again the following day using a new strip. If you get another trace Leukocyte result or if Step 1: Test for infection with the URISTAT™ UTI Test Strip.
you still have symptoms, consult a physician or Step 2: Temporarily relieve your pain with URISTAT® pain relief tablets.
TO MAXIMIZE THE ACCURACY OF THE UTI TEST STRIP, PAIN Results suggest a sign of UTI. Consult a RELIEF TABLETS SHOULD NOT BE TAKEN PRIOR TO TESTING.
physician or health professional immediately. Results suggest a sign of UTI. Consult a URISTAT™ UTI Test Strips test for white blood cells (Leukocytes) and Nitrite in urine. physician or health professional immediately. Detection of these substances in urine aids in the screening of urinary tract infections. Results suggest a sign of UTI. Consult a The UTI Test Strips are packaged individually in foil pouches. They are for over-the- physician or health professional immediately. counter, home use only.
WHEN DO I NEED TO USE UTI TEST STRIPS?
LIMITATION OF USE
Use the URISTAT™ UTI Test strips if you have a painful, burning feeling when you The reading of UTI Test Strips results may be affected by several factors.
urinate, you have to go very often, or only small amounts of urine pass even when you • Your reading of the results may be affected if you have color vision deficiency have to go very badly. Seek medical attention if your result indicates there is a possible (color blindness).
• Dehydration may cause false positive in Nitrite and false negative in Leukocyte.
WARNINGS AND PRECAUTIONS
• Urine with pH≥8.0 may cause false negative in Leukocyte.
• For urine testing only • Follow directions exactly for accurate results • You should not be using the UTI Test Strips if you are taking antibiotics.
• Keep out of the reach of children • Used strip should be discarded according to You may get false and inaccurate results if: local regulations • You have been taking medicine or dietary supplement that may change urine color STORAGE AND HANDLING
(such as drugs containing azo dyes (i.e. Pyridium® , Gantrisin®, Gantanol®), • Store in a dry place at room temperature between 20°-25°C (68°-77°F) and out of nitrofurantoin (Microdantin®, Furadantin®), riboflavin).
direct sunlight. • You are taking Vitamin C or multivitamin. • Do not open pouch until ready to use.
• You have a UTI caused by bacteria that does not change nitrate to nitrite, or if your • Do not use after expiration date.
diet does not include nitrates.
• When urine has not been held in the bladder for more than 4 hours.
Gently wash the genital area with soap and water then rinse well prior to testing.
• You are taking drugs containing acetazolamide, potassium citrate, and sodium 1. Please read all the information in this package insert carefully before performing bicarbonate because your urine pH maybe ≥8.0.
PERFORMANCE CHARACTERISTICS
2. Gather the following items: The performance characteristics of the URISTAT™ UTI Test Strips have been determined • The UTI Test Strip in CLOSED foil pouch • Paper towel(s) • Watch or Timer both in the laboratory and in clinical tests. The UTI Test Strips have been developed to • A Pen or Pencil (optional) be specific for Leukocyte and Nitrite. They can detect nitrite levels as low as 0.075-0.10 3. Remove the strip from the foil pouch and use the test immediately. If the test has
mg/dl and leukocyte levels as low as 15 White Blood Cells/µL been left out of the foil pouch for 20 minutes or more, open a new test strip.
4. Begin urinating. After some urine has passed, hold the test pads in the urine stream for 1-2 seconds. Make sure both test pads are completely wet. See figure 1 below.
If you have any questions about URISTAT™ products, please contact
5. Dab the side of the strip on a paper towel to remove excess urine. See figure 2.
Customer Service at 1-800-344-7239 or visit our website at uristat.com.
6. Lay the test strip with the test pads facing upwards and begin timing.
For medical advice or questions, consult a doctor or health professional.
7. Read test results for Nitrite after 1 minute and for Leukocytes after 2 minutes. Compare each test area to its corresponding color blocks on the color chart to obtain results. See figure 3. Be sure to read the test results before 3 minutes have
passed. Ignore any color change after 3 minutes.
8. Record the results with a pen or pencil. Compare them to the table in the Results section.
Hold strip close to color block on foil pouch. • Compare each test area to its corresponding color blocks on the color chart.
• Match the color of the test pad to the closest color block on the color chart.
• Look at the table to the right to understand what your results mean.
INSIGHT Pharmaceuticals, LLC.
Langhorne, PA 19047-1749 2011 Turn over for instructions on tablets

Source: http://www.uristat.com/sites/default/files/Uristat_PAKInsert.pdf

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Reference standards highlights

December 2012 Table of Contents Click on sections. For all the latest information, visit Reference Standards Highlights Below are several Tables with the latest Reference Standard information including out-of-stock items now available; new Reference Standards released in November 2012; backordered items with estimated availability dates; items that have a new price and/or have a new package size; items with lots that are (or soon will be) no longer valid; and items with new lots since the last email notice.