NDC: 50090-4192-0 90 TABLET, EXTENDED RELEASE in a BOTTLE
- Patients should be informed that oxybutynin may produce angioedema that could result in life threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience swelling of the tongue, edema of the laryngopharynx, or difficulty breathing.
- Patients should be informed that anticholinergic (antimuscarinic) agents such as Oxybutynin chloride extended-release tablets, may produce clinically significant adverse reactions related to anticholinergic activity such as:
- Urinary retention and constipation
- Heat prostration due to decreased sweating. Heat prostration can occur when anticholinergic medicines are administered in the presence of high environmental temperature.
- Patients should be informed that anticholinergic medicines such as Oxybutynin chloride extended-release tablets may produce drowsiness (somnolence), dizziness or blurred vision. Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until Oxybutynin chloride extended-release tablets effects have been determined.
- Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as Oxybutynin chloride extended-release tablets.
- Patients should be informed that Oxybutynin chloride extended-release tablets should be swallowed whole with the aid of liquids. Patients should not chew, divide, or crush tablets. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
- Oxybutynin chloride extended-release tablets should be taken at approximately the same time each day.
For more information call 1-844-834-0530.
Lannett Company, Inc.,
Philadelphia, PA 19136
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.
| OXYBUTYNIN CHLORIDE
EXTENDED RELEASE |
oxybutynin chloride tablet, extended release
|Labeler — A-S Medication Solutions (830016429)|
|A-S Medication Solutions||830016429||RELABEL (50090-4192), REPACK (50090-4192)|
Revised: 06/2021 A-S Medication Solutions
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