Pravastatin Sodium (Page 9 of 9)

16.2 Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

17 PATIENT COUNSELING INFORMATION

Muscle Pain

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) ].

Liver Enzymes

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 ( 5.2) ].

Embryofetal Toxicity
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) ].

Lactation
Advise women not to breastfeed during treatment with pravastatin sodium tablets [see Contraindications ( 4.4), Use in Specific Populations ( 8.2) ].

Distributed by:
Hisun Pharmaceuticals USA, Inc.
Bridgewater, NJ 08807 USA
Manufactured in China Revised: 07/2018

PRINCIPAL DISPLAY PANEL

 Pravastatin Sodium Tablets USP 20 mg 1000s Label
(click image for full-size original)

Pravastatin Sodium Tablets, USP 20 mg 1000s Label Text

PRINCIPAL DISPLAY PANEL

 Pravastatin Sodium Tablets USP 40 mg 1000s Label
(click image for full-size original)

Pravastatin Sodium Tablets, USP 40 mg 1000s Label Text

PRINCIPAL DISPLAY PANEL

 Pravastatin Sodium Tablets USP 80 mg 1000s Label
(click image for full-size original)

Pravastatin Sodium Tablets, USP 80 mg 1000s Label Text

PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42658-105
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM OXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
LACTOSE MONOHYDRATE
POWDERED CELLULOSE
FERRIC OXIDE YELLOW
HYPROMELLOSES
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color yellow (light-yellow) Score no score
Shape RECTANGLE Size 8mm
Flavor Imprint Code HU;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42658-105-04 90 TABLET in 1 BOTTLE None
2 NDC:42658-105-08 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206061 07/01/2019
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42658-106
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 40 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM OXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
LACTOSE MONOHYDRATE
POWDERED CELLULOSE
FERRIC OXIDE YELLOW
HYPROMELLOSES
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color yellow (light-yellow) Score no score
Shape RECTANGLE Size 9mm
Flavor Imprint Code HU;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42658-106-04 90 TABLET in 1 BOTTLE None
2 NDC:42658-106-08 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206061 07/01/2019
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42658-107
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 80 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM OXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
LACTOSE MONOHYDRATE
POWDERED CELLULOSE
FERRIC OXIDE YELLOW
HYPROMELLOSES
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color yellow (light-yellow) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code HU;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42658-107-04 90 TABLET in 1 BOTTLE None
2 NDC:42658-107-08 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206061 07/01/2019
Labeler — Hisun Pharmaceuiticals USA, Inc (961628505)
Establishment
Name Address ID/FEI Operations
Hisun Pfizer Pharmaceuticals Co., Ltd. 421307115 manufacture (42658-105), manufacture (42658-106), manufacture (42658-107), analysis (42658-105), analysis (42658-106), analysis (42658-107), label (42658-105), label (42658-106), label (42658-107), pack (42658-105), pack (42658-106), pack (42658-107)

Revised: 12/2018 Hisun Pharmaceuiticals USA, Inc

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.