Fenofibrate (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

145 mg white to off-white, oval-shaped, biconvex, film-coated tablets debossed with RH38 on one side and other side plain and are available as follows:

NDC 68071-4692-9 BOTTLES OF 90

Storage

Store at 20º — 25º C (68º — 77º F) [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Patients should be advised:

  • of the potential benefits and risks of fenofibrate tablets, USP.
  • not to use fenofibrate tablets, USP if there is a known hypersensitivity to fenofibrate or fenofibric acid.
  • of medications that should not be taken in combination with fenofibrate tablets, USP.
  • that if they are taking coumarin anticoagulants, fenofibrate tablets, USP may increase their anti-coagulant effect, and increased monitoring may be necessary.
  • to continue to follow an appropriate lipid-modifying diet while taking fenofibrate tablets, USP.
  • to take fenofibrate tablets, USP once daily, without regard to food, at the prescribed dose, swallowing each tablet whole.
  • to return to their physician’s office for routine monitoring.
  • to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking fenofibrate tablets, USP.
  • to inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.
  • not to breastfeed during treatment with fenofibrate tablets, USP and for 5 days after the final dose.

Manufactured by:

Sun Pharmaceutical Industries Ltd.

Mohali, INDIA

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

December 2018 FDA-06

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PDP
(click image for full-size original)

FENOFIBRATE
fenofibrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4692(NDC:63304-449)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 145 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SUCROSE
STARCH, CORN
CROSPOVIDONE (15 MPA.S AT 5%)
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
XANTHAN GUM
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code RH38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-4692-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200884 01/10/2013
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-4692)

Revised: 06/2021 NuCare Pharmaceuticals,Inc.

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