Paricalcitol (Page 6 of 6)

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-1mcg-30ct-bott-label
(click image for full-size original)

Paricalcitol Capsules 2 mcg 30 counts

paricalcitol-2mcg-30ct-bott-label
(click image for full-size original)

Paricalcitol Capsules 4 mcg 30 counts

paricalcitol-4mcg-30ct-bott-label
(click image for full-size original)
PARICALCITOL paricalcitol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-017
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 4 ug
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
ALCOHOL
BUTYLATED HYDROXYTOLUENE
GELATIN
GLYCERIN
SORBITOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
WATER
PROPYLENE GLYCOL
BUTYL ALCOHOL
SHELLAC
AMMONIA
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-017-03 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
2 NDC:25000-017-49 4 BAG in 1 BOX contains a BAG
2 7000 CAPSULE, LIQUID FILLED in 1 BAG This package is contained within the BOX (25000-017-49)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204948 12/31/2016
PARICALCITOL paricalcitol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-014
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 2 ug
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
ALCOHOL
BUTYLATED HYDROXYTOLUENE
GELATIN
GLYCERIN
SORBITOL
FERRIC OXIDE RED
WATER
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
BUTYL ALCOHOL
SHELLAC
AMMONIA
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-014-03 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
2 NDC:25000-014-49 4 BAG in 1 BOX contains a BAG
2 7000 CAPSULE, LIQUID FILLED in 1 BAG This package is contained within the BOX (25000-014-49)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204948 12/31/2016
PARICALCITOL paricalcitol capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 1 ug
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
ALCOHOL
BUTYLATED HYDROXYTOLUENE
GELATIN
GLYCERIN
SORBITOL
TITANIUM DIOXIDE
WATER
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
SHELLAC
AMMONIA
Product Characteristics
Color GRAY Score no score
Shape OVAL Size 9mm
Flavor Imprint Code 12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-012-03 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
2 NDC:25000-012-50 4 BAG in 1 BOX contains a BAG
2 10000 CAPSULE, LIQUID FILLED in 1 BAG This package is contained within the BOX (25000-012-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204948 12/31/2016
Labeler — MARKSANS PHARMA LIMITED (925822975)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 MANUFACTURE (25000-012), MANUFACTURE (25000-014), MANUFACTURE (25000-017)

Revised: 05/2017 MARKSANS PHARMA LIMITED

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