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

43063726 Label
(click image for full-size original)
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.

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