Oxybutynin (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

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

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 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please address medical inquiries to, MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 05/21

Oxybutynin Chloride ER 10mg Tab.

Label
(click image for full-size original)
OXYBUTYNIN oxybutynin tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0974(NDC:68382-256)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBUTYNIN CHLORIDE (OXYBUTYNIN) OXYBUTYNIN CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID
HYDROGENATED CASTOR OIL
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
TALC
TRIETHYL CITRATE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 256
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71335-0974-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:71335-0974-2 18 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:71335-0974-3 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:71335-0974-4 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202332 08/10/2017
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-0974), RELABEL (71335-0974)

Revised: 12/2021 Bryant Ranch Prepack

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