16 HOW SUPPLIED/STORAGE AND HANDLING
Paricalcitol Capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.
The 1 mcg capsule is gray colour oval shaped soft gelatin capsule imprinted with ‘12’ in black ink and is available in the following package size.
Bottles of 30 (NDC 25000-012-03)
The 2 mcg capsule is brown colour oval shaped soft gelatin capsule imprinted with ‘14’ in black ink and is available in the following package size.
Bottles of 30 (NDC 25000-014-03)
The 4 mcg capsule is Light yellow colour oval shaped soft gelatin capsules imprinted with ’17’ in black ink and is available in the following package size.
Bottles of 30 (NDC 25000-017-03)
STORAGE
Store Paricalcitol Capsules at 20°C to 25°C (68°F to77°F). See USP Controlled Room Temperature.
17 PATIENT COUNSELING INFORMATION
Advise patients of the following:
· The most common adverse reactions with use of Paricalcitol Capsules, which include diarrhea, hypertension, nausea, nasopharyngitis dizziness and vomiting.
· Patients should adhere adhere to instructions regarding diet and phosphorus restriction.
· Patients should contact a health care provider if you develop symptoms of elevated calcium, (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss).
· Patients should return to the physician’s office for routine monitoring. More frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued. Patients should inform their physician of all medications, including prescription and nonprescription drugs, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also inform their physician that they are taking Paricalcitol capsules if a new medication is prescribed.
· Breastfeeding is not recommended during treatment with Paricalcitol capsules [see Use in Specific Populations (8.2)].
Manufactured For:
Time-Cap Labs, Inc.
7 Michael Avenue, Farmingdale
New York 11735, USA
Made in India
Iss. 05/17
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Paricalcitol Capsules 1 mcg 30 counts
Paricalcitol Capsules 2 mcg 30 counts
Paricalcitol Capsules 4 mcg 30 counts
PARICALCITOL paricalcitol capsule, liquid filled |
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PARICALCITOL paricalcitol capsule, liquid filled |
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PARICALCITOL paricalcitol capsule, liquid filled |
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Revised: 05/2017 MARKSANS PHARMA LIMITED
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https://medlibrary.org/lib/rx/meds/paricalcitol-18/page/6/