URELLE
-
hyoscyamine sulfate,
methenamine,
methylene blue,
phenyl salicylate and
sodium phosphate, monobasic, monohydrate tablet
Azur Pharma Inc.
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Urelle® Urinary AntisepticDESCRIPTION
Urelle® tablets for oral administration are supplied as navy blue round tablets with “A-002” debossed on one side.
Each Tablet Contains:
Hyoscyamine Sulfate 0.12 mg
Methenamine 81.0 mg
Methylene Blue 10.8 mg
Phenyl Salicylate 32.4 mg
Sodium Phosphate Monobasic 40.8 mg
INACTIVE INGREDIENTS
Corn Starch, Dicalcium Phosphate, FD&C Blue #2/Indigo Carmine Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide.
INDICATIONS AND USAGE
Urelle® is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients is possible. Risk - benefit should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).
WARNINGS
If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately.
Patients should be advised that urine will be colored blue when taking this medication.
Do not exceed recommended dosage.
PRECAUTIONS
Cross sensitivity and/or related problems - patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.
DOSAGE AND ADMINISTRATION
Adults – One tablet orally 4 times per day followed by liberal fluid intake.
Pediatric – Dosage must be individualized by a physician for older children. Urelle® is not recommended for use in children 6 years of age or younger.
HOW SUPPLIED
Urelle® tablets for oral administration are supplied in child resistant bottles of 90 tablets (NDC 66663-219-01).
Store at controlled room temperature 15°-30°C (59°-86°F).
Dispense in a tight, light resistant container as defined in the USP.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Distributed by: Pharmelle a division of AZUR PHARMA, INC. • 1818 Market Street, Suite 2350 • Philadelphia, PA 19103 • www.azurpharma.com
Manufactured by: PureTek Corporation. San Fernando, CA 91340
Urelle® is a registered trademark of Azur Pharma International II Limited.
To report a serious adverse event or obtain product information, contact (800) 890 3098.
Rx Only
URLLw-10-01
PRINCIPAL DISPLAY PANEL - BOTTLE LABEL
Description: Urelle® tablets for oral administration
are supplied as navy blue round tablets with
"A-002" debossed on one side.
Each Tablet Contains:
Hyoscyamine Sulfate 0.12 mg
Methenamine 81.0 mg
Methylene Blue 10.8 mg
Phenyl Salicylate 32.4 mg
Sodium Phosphate Monobasic 40.8 mg
Dosage: Adults - one tablet orally 4 times per day
followed by liberal fluid intake. Pediatric - Dosage
must be individualized by a physician for older
children. Urelle® is not recommended for use in
children 6 years of age or younger.
Note: Patients should be advised that urine will be
colored blue when taking this medication.
Storage: Store at controlled room temperature
15°-30°C (59°-86°F). Dispense in a tight, light
resistant container as defined in the USP.
KEEP OUT OF THE REACH OF CHILDREN.
90 TABLETS NDC 66663-219-01
urelle®
Urinary Antiseptic
Rx Only
Dist. by: Pharmelle, a division of AZUR PHARMA, INC.
1818 Market Street, Suite 2350
Philadelphia, PA 19103
www.azurpharma.com
Mfd. by: PureTek Corporation
San Fernando, CA 91340
Urelle is a registered trademark of Azur Pharma International II Limited.
To report a serious adverse event or obtain product information, contact (800) 890 3098.
URLLt-10-02
Bottle Label
| URELLE
urelle tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 01/01/2002 | ||
| Labeler - Azur Pharma Inc. (805611071) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| PureTek Corporation | 031678746 | MANUFACTURE | |