NDC: 71335-0974-1: 30 Tablets in a BOTTLE
NDC: 71335-0974-2: 18 Tablets in a BOTTLE
NDC: 71335-0974-3: 90 Tablets in a BOTTLE
NDC: 71335-0974-4: 60 Tablets 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:
○ 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 hydrated polymer system of the tablet is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.
- Oxybutynin chloride extended-release tablets should be taken at approximately the same time each day.
Please address medical inquiries to, MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779
Cadila Healthcare Ltd.
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534
Oxybutynin Chloride ER 10mg Tab.
|OXYBUTYNIN oxybutynin tablet, film coated, extended release|
|Labeler — Bryant Ranch Prepack (171714327)|
|Registrant — Bryant Ranch Prepack (171714327)|
|Bryant Ranch Prepack||171714327||REPACK (71335-0974), RELABEL (71335-0974)|
Revised: 12/2021 Bryant Ranch Prepack
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