Simvastatin (Page 11 of 11)

17.2 Liver Enzymes

It is recommended that liver function tests be performed before the initiation of simvastatin tablets, and thereafter when clinically indicated. All patients treated with simvastatin tablets should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

17.3 Pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using simvastatin tablets. Discuss future pregnancy plans with your patients, and discuss when to stop taking simvastatin tablets if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking simvastatin tablets and call their healthcare professional.

17.4 Breastfeeding

Women who are breastfeeding should not use simvastatin tablets. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.

Manufactured For:

Accord Healthcare, Inc.,

1009 Slater Road,

Suite 210-B,

Durham, NC 27703,

USA

Manufactured By:

Intas Pharmaceuticals Limited,

Ahmedabad -380 054, India.

10 2959 3 605000

Issued November 2020

PRINCIPAL DISPLAY PANEL

SIMVASTATIN simvastatin tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-726(NDC:16729-006) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 40 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE (110000 WAMW) HYPROMELLOSE 2910 (5 MPA.S) CROSCARMELLOSE SODIUM FERRIC OXIDE RED LACTOSE MONOHYDRATE MAGNESIUM STEARATE TALC STARCH, CORN BUTYLATED HYDROXYANISOLE TITANIUM DIOXIDE ASCORBIC ACID CITRIC ACID MONOHYDRATE TRIETHYL CITRATE

Product Characteristics Color red (Brick Red) Score no score Shape OVAL (OVAL) Size 14mm Flavor Imprint Code S6 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43063-726-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None 2 NDC:43063-726-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078155 02/26/2008

Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack (43063-726)

Revised: 05/2022 PD-Rx Pharmaceuticals, Inc.