Oxybutynin Chloride Extended Release (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-4192

NDC: 50090-4192-0 90 TABLET, EXTENDED RELEASE in a BOTTLE

17 PATIENT COUNSELING INFORMATION

  • 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.

Distributed by:

Lannett Company, Inc.,

Philadelphia, PA 19136

CIA72763N

Rev. 04/2021

Storage

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

Label ImageLabel Image
OXYBUTYNIN CHLORIDE EXTENDED RELEASE
oxybutynin chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4192(NDC:62175-270)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBUTYNIN CHLORIDE (OXYBUTYNIN) OXYBUTYNIN CHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
CELLULOSE ACETATE
SILICON DIOXIDE
ANHYDROUS DEXTROSE
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
TARTARIC ACID
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code KU;270
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4192-0 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078503 03/01/2009
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4192), REPACK (50090-4192)

Revised: 06/2021 A-S Medication Solutions

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