Pravastatin sodium tablets, USP are supplied as:
20 mg tablets: Yellow coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘2’ on other side. They are supplied in bottles as follows.
|43063-807-30||Bottle of 30 tablets|
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.
Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing pravastatin sodium tablets [see Warnings and Precautions (5.1)].
It is recommended that liver enzyme tests be performed before the initiation of pravastatin sodium tablets, and thereafter when clinically indicated. All patients treated with pravastatin sodium tablets should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.3)].
Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4.3), Use in Specific Populations (8.1, 8.3)] .
Accord Healthcare, Inc.,
1009, Slater Road,
Durham, NC 27703,
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
10 0983 1 6005285
Issued November 2020
Pravastatin Sodium Tablets USP
|PRAVASTATIN SODIUM pravastatin sodium tablet|
|Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)|
|Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)|
|PD-Rx Pharmaceuticals, Inc.||156893695||repack (43063-807)|
Revised: 01/2022 PD-Rx Pharmaceuticals, Inc.
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