Rosuvastatin tablets are indicated:

• To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor.
• As an adjunct to diet to:
• Reduce LDL-C in adults with primary hyperlipidemia.
• Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.
• Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
• As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).
• As an adjunct to diet for the treatment of adults with:
• Primary dysbetalipoproteinemia.
• Hypertriglyceridemia.

Rosuvastatin tablets, USP:

• 5 mg of rosuvastatin: Pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘29’ on the other side.
• 10 mg of rosuvastatin: Pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘30’ on the other side.
• 20 mg of rosuvastatin: Pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘31’ on the other side.
• 40 mg of rosuvastatin: Pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘32’ on the other side.

Rosuvastatin tablets are contraindicated in the following conditions:

• Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)]. [see Warnings and Precautions (5.3)].
• Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin [see Adverse Reactions (6.1)].

The following important adverse reactions are described below and elsewhere in the labeling:

Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)]

Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2)]

Hepatic Dysfunction [see Warnings and Precautions (5.3)]

Proteinuria and Hematuria [see Warnings and Precautions (5.4)]

Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.5)]

No specific antidotes for rosuvastatin are known. Hemodialysis does not significantly enhance clearance of rosuvastatin. Contact Poison Control (1-800-222-1222) for latest recommendations.

Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor.

The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula:

The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium USP is a white to off-white powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.

Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

Meets USP Dissolution Test-2.

Primary Prevention of Cardiovascular Disease
In the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, the effect of rosuvastatin on the occurrence of major cardiovascular (CV) disease events was assessed in 17,802 men (≥50 years) and women (≥60 years) who had no clinically evident cardiovascular disease, LDL-C levels <130 mg/dL and hsCRP levels ≥2 mg/L. The study population had an estimated baseline coronary heart disease risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL-C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%). Patients had a median baseline LDL-C of 108 mg/dL and hsCRP of 4.3 mg/L. Patients were randomly assigned to placebo (n=8901) or rosuvastatin 20 mg once daily (n=8901) and were followed for a mean duration of 2 years. The JUPITER study was stopped early by the Data Safety Monitoring Board due to meeting predefined stopping rules for efficacy in rosuvastatin-treated subjects.

The primary end point was a composite end point consisting of the time-to-first occurrence of any of the following major CV events: CV death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina or an arterial revascularization procedure.

Rosuvastatin significantly reduced the risk of major CV events (252 events in the placebo group vs. 142 events in the rosuvastatin group) with a statistically significant (p<0.001) relative risk reduction of 44% and absolute risk reduction of 1.2% (see Figure 1). The risk reduction for the primary end point was consistent across the following predefined subgroups: age, sex, race, smoking status, family history of premature CHD, body mass index, LDL-C, HDL-C, and hsCRP levels.

Figure 1 Time to First Occurrence of Major Cardiovascular Events in JUPITER

The individual components of the primary end point are presented in Figure 3. Rosuvastatin significantly reduced the risk of nonfatal myocardial infarction, nonfatal stroke, and arterial revascularization procedures. There were no significant treatment differences between the rosuvastatin and placebo groups for death due to cardiovascular causes or hospitalizations for unstable angina.

Rosuvastatin significantly reduced the risk of myocardial infarction (6 fatal events and 62 nonfatal events in placebo-treated subjects vs. 9 fatal events and 22 nonfatal events in rosuvastatin-treated subjects) and the risk of stroke (6 fatal events and 58 nonfatal events in placebo-treated subjects vs. 3 fatal events and 30 nonfatal events in rosuvastatin-treated subjects).

In a post-hoc subgroup analysis of JUPITER subjects (rosuvastatin=725, placebo=680) with a hsCRP ≥2 mg/L and no other traditional risk factors (smoking, BP ≥140/90 or taking antihypertensives, low HDL-C) other than age, after adjustment for high HDL-C, there was no significant treatment benefit with rosuvastatin treatment.

Figure 2 Major CV Events by Treatment Group in JUPITER

At one year, rosuvastatin increased HDL-C and reduced LDL-C, hsCRP, total cholesterol and serum triglyceride levels (p<0.001 for all versus placebo).

Primary Hyperlipidemia in Adults
Rosuvastatin reduces Total-C, LDL-C, ApoB, non-HDL-C, and TG, and increases HDL-C, in adult patients with hyperlipidemia and mixed dyslipidemia.

In a multicenter, double-blind, placebo-controlled study in patients with hyperlipidemia, rosuvastatin given as a single daily dose (5 to 40 mg) for 6 weeks significantly reduced Total-C, LDL-C, non-HDL-C, and ApoB, across the dose range (Table 10).

Rosuvastatin was compared with the statins (atorvastatin, simvastatin, and pravastatin) in a multicenter, open-label, dose-ranging study of 2240 patients with hyperlipidemia or mixed dyslipidemia. After randomization, patients were treated for 6 weeks with a single daily dose of either rosuvastatin, atorvastatin, simvastatin, or pravastatin (Figure 3 and Table 11).

Figure 3 Percent LDL-C Change by Dose of Rosuvastatin, Atorvastatin, Simvastatin, and Pravastatin at Week 6 in Adult Patients with Hyperlipidemia or Mixed Dyslipidemia

Slowing of the Progression of Atherosclerosis
In the Measuring Effects on Intima Media Thickness: an Evaluation Of Rosuvastatin 40 mg (METEOR) study, the effect of therapy with rosuvastatin on carotid atherosclerosis was assessed by B-mode ultrasonography in patients with elevated LDL-C, at low risk (Framingham risk <10% over ten years) for symptomatic coronary artery disease and with subclinical atherosclerosis as evidenced by carotid intimal-medial thickness (cIMT). In this double-blind, placebo-controlled clinical study 984 adult patients were randomized (of whom 876 were analyzed) in a 5:2 ratio to rosuvastatin 40 mg or placebo once daily. Ultrasonograms of the carotid walls were used to determine the annualized rate of change per patient from baseline to two years in mean maximum cIMT of 12 measured segments. The estimated difference in the rate of change in the maximum cIMT analyzed over all 12 carotid artery sites between patients treated with rosuvastatin and placebo-treated patients was -0.0145 mm/year (95% CI –0.0196, – 0.0093; p<0.0001).

The annualized rate of change from baseline for the placebo group was +0.0131 mm/year (p<0.0001). The annualized rate of change from baseline for the group treated with rosuvastatin was -0.0014 mm/year (p=0.32).

At an individual patient level in the group treated with rosuvastatin, 52.1% of patients demonstrated an absence of disease progression (defined as a negative annualized rate of change), compared to 37.7% of patients in the placebo group.

HeFH in Adults
In a study of adult patients with HeFH (baseline mean LDL of 291 mg/dL), patients were randomized to rosuvastatin 20 mg or atorvastatin 20 mg. The dose was increased at 6-week intervals. Significant LDL-C reductions from baseline were seen at each dose in both treatment groups (Table 12).

HeFH in Pediatric Patients
In a double-blind, randomized, multicenter, placebo-controlled, 12-week study, 176 (97 male and 79 female) children and adolescents with heterozygous familial hypercholesterolemia were randomized to rosuvastatin 5 mg, 10 mg or 20 mg or placebo daily. Patients ranged in age from 10 to 17 years (median age of 14 years) with approximately 30% of the patients 10 to 13 years and approximately 17%, 18%, 40%, and 25% at Tanner stages II, III, IV, and V, respectively. Females were at least 1 year postmenarche. Mean LDL-C at baseline was 233 mg/dL (range of 129 to 399). The 12-week double-blind phase was followed by a 40 week open label dose-titration phase, where all patients (n=173) received 5 mg, 10 mg or 20 mg rosuvastatin daily.

Rosuvastatin significantly reduced LDL-C (primary end point), total cholesterol and ApoB levels at each dose compared to placebo. Results are shown in Table 13 below.

Rosuvastatin was also studied in a two-year open-label, uncontrolled, titration-to-goal trial that included 175 children and adolescents with heterozygous familial hypercholesterolemia who were 8 to 17 years old (79 boys and 96 girls). All patients had a documented genetic defect in the LDL receptor or in ApoB. Approximately 89% were White, 7% were Asian, 1% were Black, and fewer than 1% were Hispanic. Mean LDL-C at baseline was 236 mg/dL. Fifty-eight (33%) patients were prepubertal at baseline. The starting rosuvastatin dosage for all children and adolescents was 5 mg once daily. Children 8 to less than 10 years of age (n=41 at baseline) could titrate to a maximum dosage of 10 mg once daily, and children and adolescents 10 to 17 years of age could titrate to a maximum dosage of 20 mg once daily.

The reductions in LDL-C from baseline were generally consistent across age groups within the trial as well as with previous experience in both adult and pediatric controlled trials.

HoFH in Adult and Pediatric Patients
In an open-label, forced-titration study, HoFH patients (n=40, 8 to 63 years) were evaluated for their response to rosuvastatin 20 to 40 mg titrated at a 6-week interval. In the overall population, the mean LDL-C reduction from baseline was 22%. About one-third of the patients benefited from increasing their dose from 20 mg to 40 mg with further LDL-C lowering of greater than 6%. In the 27 patients with at least a 15% reduction in LDL-C, the mean LDL-C reduction was 30% (median 28% reduction). Among 13 patients with an LDL-C reduction of <15%, 3 had no change or an increase in LDL-C. Reductions in LDL-C of 15% or greater were observed in 3 of 5 patients with known receptor negative status.

HoFH in Pediatric Patients
Rosuvastatin was studied in a randomized, double-blind, placebo-controlled, multicenter, cross-over study in 14 pediatric patients with HoFH. The study included a 4-week dietary lead-in phase during which patients received rosuvastatin 10 mg daily, a cross-over phase that included two 6-week treatment periods with either rosuvastatin 20 mg or placebo in random order, followed by a 12-week open-label phase during which all patients received rosuvastatin 20 mg. Patients ranged in age from 7 to 15 years of age (median 11 years), 50% were male, 71% were White, 21% were Asian, 7% were Black, and no patients were of Hispanic ethnicity. Fifty percent were on apheresis therapy and 57% were taking ezetimibe. Patients who entered the study on apheresis therapy or ezetimibe continued the treatment throughout the entire study. Mean LDL-C at baseline was 416 mg/dL (range 152 to 716 mg/dL). A total of 13 patients completed both treatment periods of the randomized cross-over phase; one patient withdrew consent due to inability to have blood drawn during the cross-over phase.

Rosuvastatin 20 mg significantly reduced LDL-C, total cholesterol, ApoB, and non-HDL-C compared to placebo (Table 14).

% Difference estimates are based on transformations of the estimated mean difference in log LDL measurements between rosuvastatin and placebo using a mixed model adjusted for study period

Primary Dysbetalipoproteinemia in Adults
In a randomized, multicenter, double-blind crossover study, 32 adult patients (27 with ε2/ε2 and 4 with apo E mutation [Arg145Cys] with primary dysbetalipoproteinemia entered a 6-week dietary lead-in period on the NCEP Therapeutic Lifestyle Change (TLC) diet. Following dietary lead-in, patients were randomized to a sequence of treatments for 6 weeks each: rosuvastatin 10 mg followed by rosuvastatin 20 mg or rosuvastatin 20 mg followed by rosuvastatin 10 mg. Rosuvastatin reduced non-HDL-C (primary end point) and circulating remnant lipoprotein levels. Results are shown in the table below.

Hypertriglyceridemia in Adults
In a double-blind, placebo-controlled study in adult patients with baseline TG levels from 273 to 817 mg/dL, rosuvastatin given as a single daily dose (5 to 40 mg) over 6 weeks significantly reduced serum TG levels (Table 16).

Rosuvastatin tablets USP 5 mg are pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘29’ on the other side.

Unit dose packages of 100 (10 x 10) NDC 60687-234-01

Rosuvastatin tablets USP 10 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘30’ on the other side.

Unit dose packages of 50 (5 x 10) NDC 60687-245-65
Unit dose packages of 100 (10 x 10) NDC 60687-245-01

Rosuvastatin tablets USP 20 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘31’ on the other side.

Unit dose packages of 100 (10 x 10) NDC 60687-256-01

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]. Protect from moisture.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Myopathy and Rhabdomyolysis
Advise patients that rosuvastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1), and Drug Interactions (7.1)] .

Hepatic Dysfunction
Inform patients that rosuvastatin may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3)] .

Increases in HbA1c and Fasting Serum Glucose Levels
Inform patients that increases in HbA1c and fasting serum glucose levels may occur with rosuvastatin. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.5)] .

Pregnancy
Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if rosuvastatin should be discontinued [see Use in Specific Populations (8.1)] .

Lactation
Advise patients that breastfeeding during treatment with rosuvastatin is not recommended [see Use in Specific Populations (8.2)] .

Concomitant Use of Antacids
When taking rosuvastatin with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin administration [see Drug Interactions (7.2)] .

Missed Doses
If a dose is missed, advise patients not take an extra dose. Just resume the usual schedule [seeGeneral Dosage and Administration Information (2.1)].

CRESTOR is a trademark of the AstraZeneca group of companies.

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Rising Health, LLC as follows:
(5 mg / 100 UD) NDC 60687-234-01 packaged from NDC 57237-168
(10 mg / 50 UD) NDC 60687-245-65 packaged from NDC 57237‐169
(10 mg / 100 UD) NDC 60687-245-01 packaged from NDC 57237-169
(20 mg / 100 UD) NDC 60687-256-01 packaged from NDC 57237-170

Distributed by:
American Health Packaging
Columbus, OH 43217

8423401/0524F

8423401/0524F

Rosuvastatin Tablets USP
(roe-SOO-va-STAT-in)

Read this Patient Information carefully before you start taking rosuvastatin tablets and each time you get a refill. If you have any questions about rosuvastatin tablets, ask your doctor. Only your doctor can determine if rosuvastatin tablets are right for you.

What are rosuvastatin tablets?
Rosuvastatin tablets are a prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin.

• Rosuvastatin tablets are used to:
  • reduce the risk of stroke, heart attack, and the need for procedures to improve blood flow to the heart called arterial revascularization in adults who do not have known heart disease but do have certain additional risk factors.
• Rosuvastatin tablets are used along with diet to:
  • lower the level of low-density lipoprotein (LDL) cholesterol or “bad” cholesterol in adults with primary hyperlipidemia.
  • slow the buildup of fatty deposits (plaque) in the walls of blood vessels.
  • treat adults and children 8 years of age and older with high blood cholesterol due to heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL).
  • along with other cholesterol lowering treatments or alone if such treatments are unavailable in adults and children 7 years of age and older with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL).
  • treat adults with a type of high cholesterol called primary dysbetalipoproteinemia (type III hyperlipoproteinemia).
  • lower the level of fat in your blood (triglycerides) in adults with hypertriglyceridemia.

The safety and effectiveness of rosuvastatin tablets has not been established in children younger than 8 years of age with heterozygous familial hypercholesterolemia or children younger than 7 years of age with homozygous familial hypercholesterolemia or in children with other types of hyperlipidemias (other than HeFH or HoFH).

Who should not take rosuvastatin tablets?
Do not take rosuvastatin tablets if you:

• have liver problems.
• are allergic to rosuvastatin or any of the ingredients in rosuvastatin tablets. See the end of this leaflet for a complete list of ingredients in rosuvastatin tablets. Symptoms of allergic reactions include rash, itching, hives, and swelling.

What should I tell my doctor before and while taking rosuvastatin tablets?
Tell your doctor if you:

• have unexplained muscle aches or weakness
• have or have had kidney problems
• have or have had liver problems
• drink more than 2 glasses of alcohol daily
• have thyroid problems
• are 65 years of age or older
• are of Asian descent
• are pregnant or think you may be pregnant, or are planning to become pregnant. If you become pregnant while taking rosuvastatin tablets, call your healthcare provider right away to discuss your rosuvastatin tablets treatment.
• are breastfeeding. Rosuvastatin calcium can pass into your breast milk. Breastfeeding is not recommended while taking rosuvastatin tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking rosuvastatin tablets with certain other medicines may affect each other causing side effects. Rosuvastatin tablets may affect the way other medicines work, and other medicines may affect how rosuvastatin tablets work.

Especially tell your doctor if you take:

• cyclosporine (a medicine for your immune system)
• gemfibrozil (a fibric acid medicine for lowering cholesterol)
• fostamatinib (a medicine used to treat low platelet counts)
• febuxostat (a medicine used to treat and prevent high blood levels of uric acid)
• teriflunomide (a medicine used to treat relapsing remitting multiple sclerosis)
• capmatinib (a medicine for the treatment of non-small cell lung cancer)
• tafamidis (used to treat cardiomyopathy [enlarged and thickened heart muscle])
• darolutamide (a medicine for the treatment of prostate cancer)
• regorafenib (a medicine used to treat cancer of the colon and rectum)
• enasidenib (a medicine used to treat acute myeloid leukemia)
• anti-viral medicines including certain HIV or hepatitis C virus drugs such as:
• lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir
• combination of
• sofosbuvir/velpatasvir/voxilaprevir
• dasabuvir/ombitasvir/paritaprevir/ritonavir
• elbasvir/grazoprevir
• sofosbuvir/velpatasvir
• glecaprevir/pibrentasvir and
• all other combinations with ledipasvir including ledipasvir/sofosbuvir
• certain anti-fungal medicines (such as itraconazole, ketoconazole and fluconazole)
• coumarin anticoagulants (medicines that prevent blood clots, such as warfarin)
• niacin or nicotinic acid
• fibric acid derivatives (such as fenofibrate)
• colchicine (a medicine used to treat gout)

Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know all of the medicines you take. Keep a list of them to show your doctor and pharmacist when you get new medicine.

How should I take rosuvastatin tablets?

• Take rosuvastatin tablets exactly as your doctor tells you to take them.
• Take rosuvastatin tablets, by mouth, 1 time each day. Swallow the tablet whole.
• Rosuvastatin tablets can be taken at any time of day, with or without food.
• Do not change your dose or stop rosuvastatin tablets without talking to your doctor, even if you are feeling well.
• Your doctor may do blood tests to check your cholesterol levels before and during your treatment with rosuvastatin tablets. Your doctor may change your dose of rosuvastatin tablets if needed.
• Your doctor may start you on a cholesterol lowering diet before giving you rosuvastatin tablets. Stay on this diet when you take rosuvastatin tablets.
• Wait at least 2 hours after taking rosuvastatin tablets to take an antacid that contains a combination of aluminum and magnesium hydroxide.
• If you miss a dose of rosuvastatin tablets, take your next dose at your normal scheduled time. Do not take an extra dose of rosuvastatin tablets.
• If you take too much rosuvastatin calcium or overdose, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of rosuvastatin tablets?
Rosuvastatin tablets may cause serious side effects, including:

• Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your doctor right away if:
• you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take rosuvastatin tablets.
• you have muscle problems that do not go away even after your doctor has told you to stop taking rosuvastatin tablets. Your doctor may do further tests to diagnose the cause of your muscle problems.

Your chances of getting muscle problems are higher if you:

• are taking certain other medicines while you take rosuvastatin tablets
• are 65 years of age or older
• have thyroid problems (hypothyroidism) that are not controlled
• have kidney problems
• are taking higher doses of rosuvastatin tablets
• Liver problems. Your doctor should do blood tests to check your liver before you start taking rosuvastatin tablets and if you have symptoms of liver problems while you take rosuvastatin tablets. Call your doctor right away if you have any of the following symptoms of liver problems:
• feel unusually tired or weak
• loss of appetite
• upper belly pain
• dark urine
• yellowing of your skin or the whites of your eyes
• Protein and blood in the urine. Rosuvastatin tablets may cause you to have protein and blood in your urine. If you develop protein or blood in your urine, your doctor may decrease your dose of rosuvastatin tablets.
• Increase in blood sugar (glucose) levels. Rosuvastatin tablets may cause an increase in your blood sugar levels.

The most common side effects may include: headache, muscle aches and pains, abdominal pain, weakness, and nausea.

Tell your doctor if you have any side effect that bothers you or that does not go away.

For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store rosuvastatin tablets?

• Store rosuvastatin tablets at room temperature, between 68° to 77°F (20° to 25°C) and in a dry place.
• Safely throw away medicine that is out of date or no longer needed.

Keep rosuvastatin tablets and all medicines out of the reach of children.

General Information about the safe and effective use of rosuvastatin tablets
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use rosuvastatin tablets for a condition for which it was not prescribed. Do not give rosuvastatin tablets to other people, even if they have the same medical condition you have. They may harm them.

You can ask your pharmacist or doctor for information about rosuvastatin tablets that is written for health professionals.

What are the Ingredients in rosuvastatin tablets?
Active Ingredient: rosuvastatin as rosuvastatin calcium
Inactive Ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

CRESTOR is a trademark of the AstraZeneca group of companies.

Distributed by:
American Health Packaging
Columbus, OH 43217

8423401/0524F

For more information about the drug product, call Rising Health, LLC at 1-833-395-6928.
For more information about the packaging and labeling, call American Health Packaging at 1-800-707-4621.

This Patient Information has been approved by the U.S. Food and Drug Administration.

NDC 60687- 234-01

Rosuvastatin
Tablets USP

5 mg

100 Tablets (10 x 10)          Rx Only

Each Film-Coated Tablet Contains:
Rosuvastatin calcium USP equivalent to rosuvastatin 5 mg.

Usual Dosage: See full prescribing information.

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

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 57237-168, Rising Health, LLC.

Distributed by: American Health Packaging, Columbus,
Ohio 43217

723401
0423401/0524

Rosuvastatin
Tablet USP

5 mg

NDC 60687- 245-65

Rosuvastatin
Tablets USP

10 mg

50 Tablets (5 x 10)               Rx Only

Each Film-Coated Tablet Contains:
10.4 mg rosuvastatin calcium USP equivalent to rosuvastatin 10 mg.

Usual Dosage: See full prescribing information.

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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 57237-169, Rising Health, LLC.

Distributed by: American Health Packaging, Columbus, Ohio 43217

724565
0424565/0524

NDC 60687- 245-01

Rosuvastatin
Tablets USP

10 mg

100 Tablets (10 x 10)          Rx Only

Each Film-Coated Tablet Contains:
10.4 mg rosuvastatin calcium USP equivalent to
rosuvastatin 10 mg.

Usual Dosage: See full prescribing information.

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

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 57237-169, Rising Health, LLC.

Distributed by: American Health Packaging, Columbus,
Ohio 43217

724501
0424501/0524

Rosuvastatin
Tablet USP

10 mg

NDC 60687- 256-01

Rosuvastatin
Tablets USP

20 mg

100 Tablets (10 x 10)          Rx Only

Each Film-Coated Tablet Contains:
Rosuvastatin calcium USP equivalent to rosuvastatin 20 mg.

Usual Dosage: See full prescribing information.

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

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 57237-170, Rising Health, LLC.

Distributed by: American Health Packaging, Columbus,
Ohio 43217

725601
0425601/0524

Rosuvastatin
Tablet USP

20 mg