These highlights do not include all the information needed to use RIOMET safely and effectively. See full prescribing information for RIOMET. RIOMET® (metformin hydrochloride) solution, for oral use Initial U.S. Approval: 1995

WARNING: LACTIC ACIDOSIS

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin‑ associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin‑ associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1)].

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see Dosage and Administration (2.3), Contraindications (4), Warnings and Precautions (5.1)].

If metformin-associated lactic acidosis is suspected, immediately discontinue RIOMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

RIOMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

2 DOSAGE AND ADMINISTRATION

2.1 Adult Dosage

• •Measure the RIOMET dose in the RIOMET specific dosing cup.
• •The recommended starting dose of RIOMET is 500 mg (5 mL) orally twice a day or 850 mg (8.5 mL) once a day, given with meals.
• •Increase the dose in increments of 500 mg (5 mL) weekly or 850 mg (8.5 mL) every 2 weeks on the basis of glycemic control and tolerability, up to a maximum dose of 2,550 mg (25.5 mL) per day, given in divided doses.
• •Doses above 2,000 mg (20 mL) may be better tolerated given in divided doses 3 times a day with meals.

2.2 Pediatric Dosage

• •Measure the RIOMET dose in the RIOMET specific dosing cup.
• •The recommended starting dose of RIOMET for pediatric patients 10 years of age and older is 500 mg (5 mL) orally twice a day, given with meals.
• •Increase dosage in increments of 500 mg (5 mL) weekly on the basis of glycemic control and tolerability, up to a maximum of 2,000 mg (20 mL) per day, given in divided doses twice daily.

2.3 Recommendations for Use in Renal Impairment

• •Assess renal function prior to initiation of RIOMET and periodically thereafter.
• •RIOMET is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2.
• •Initiation of RIOMET in patients with an eGFR between 30 to 45 mL/minute/1.73 m2 is not recommended.
• •In patients taking RIOMET whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit risk of continuing therapy.
• •Discontinue RIOMET if the patient’s eGFR later falls below 30 mL/minute/1.73 m2 [see Warnings and Precautions (5.1)].

2.4 Discontinuation for Iodinated Contrast Imaging Procedures

• •Discontinue RIOMET at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart RIOMET if renal function is stable.

3 DOSAGE FORMS AND STRENGTHS

Oral solution: 500 mg per 5 mL (100 mg/mL) clear solution in cherry and strawberry flavor

4 CONTRAINDICATIONS

• 1.RIOMET is contraindicated in patients with:
• 2.Severe renal impairment (eGFR below 30 mL/min/1.73 m2) [see Warnings and Precautions (5.1)].
• 3.Hypersensitivity to metformin.
• 4.Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

5 WARNINGS AND PRECAUTIONS

5.1 Lactic Acidosis

• •There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin‑associated lactic acidosis was characterized by elevated blood lactate concentrations (> 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate: pyruvate ratio; metformin plasma levels were generally > 5 mcg/mL. Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk.
• •If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of RIOMET. In RIOMET treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions). Hemodialysis has often resulted in reversal of symptoms and recovery.
• •Educate patients and their families about the symptoms of lactic acidosis and, if these symptoms occur, instruct them to discontinue RIOMET and report these symptoms to their healthcare provider.
• •For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:
• •Before initiating RIOMET, obtain an estimated glomerular filtration rate (eGFR).
• •RIOMET is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 [see Contraindications (4)].
• •Initiation of RIOMET is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m2.
• •Obtain an eGFR at least annually in all patients taking RIOMET. In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently.
• •In patients taking RIOMET whose eGFR falls below 45 mL/min/1.73 m2, assess the benefit and risk of continuing therapy.
• •Renal impairment—The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment.
• •The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient’s renal function include [see Dosage and Administration (2.3), Clinical Pharmacology (12.3)]:
• •Before initiating RIOMET, obtain an estimated glomerular filtration rate (eGFR).
• •RIOMET is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 [see Contraindications (4)].
• •Initiation of RIOMET is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m2.
• •Obtain an eGFR at least annually in all patients taking RIOMET. In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently.
• •In patients taking RIOMET whose eGFR falls below 45 mL/min/1.73 m2, assess the benefit and risk of continuing therapy.
• •Drug interactions — The concomitant use of RIOMET with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance, or increase metformin accumulation. Consider more frequent monitoring of patients [see Drug Interactions (7)].
• •Age 65 or greater — The risk of metformin-associated lactic acidosis increases with the patient’s age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients. Assess renal function more frequently in elderly patients.
• •Radiologic studies with contrast — Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis. Stop RIOMET at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and restart RIOMET if renal function is stable.
• •Surgery and other procedures — Withholding of food and fluids during surgical or other procedures may increase the risk for volume depletion, hypotension, and renal impairment. RIOMET should be temporarily discontinued while patients have restricted food and fluid intake.
• •Hypoxic states — Several of the postmarketing cases of metformin-associated lactic acidosis occurred in the setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia). Cardiovascular collapse (shock), acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may cause prerenal azotemia. When such an event occurs, discontinue RIOMET.
• •Excessive alcohol intake — Alcohol potentiates the effect of metformin on lactate metabolism. Patients should be warned against excessive alcohol intake while receiving RIOMET.
• •Hepatic impairment — Patients with hepatic impairment have developed cases of metformin-associated lactic acidosis. This may be due to impaired lactate clearance resulting in higher lactate blood levels. Therefore, avoid use of RIOMET in patients with clinical or laboratory evidence of hepatic disease.

5.2 Vitamin B12 Deficiency

• 1.In clinical trials of 29-week duration with metformin hydrochloride (HCl) tablets, a decrease to subnormal levels of previously normal serum vitamin B12 levels was observed in approximately 7% of patients. Such decrease, possibly due to interference with B12 absorption from the B12-intrinsic factor complex, may be associated with anemia but appears to be rapidly reversible with discontinuation of metformin or vitamin B12 supplementation. Certain individuals (those with inadequate vitamin B12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B12 levels. Measure hematologic parameters on an annual basis and vitamin B12 at 2 to 3 year intervals in patients on RIOMET and manage any abnormalities [see Adverse Reactions (6.1)].

5.3 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues

Insulin and insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia. RIOMET may increase the risk of hypoglycemia when combined with insulin and/or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with RIOMET [see Drug Interactions (7)].

5.4 Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with RIOMET.

6 ADVERSE REACTIONS

• •The following adverse reactions are also discussed elsewhere in the labeling:
• •Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1)]
• •Vitamin B12 Deficiency [see Warnings and Precautions (5.2)]
• •Hypoglycemia [see Warnings and Precautions (5.3)]

6.1 Clinical Studies Experience

• 1.Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• 2.In a U.S. clinical trial of metformin HCl tablets in patients with type 2 diabetes mellitus, a total of 141 patients received metformin HCl tablets up to 2,550 mg per day. Adverse reactions reported in greater than 5% of patients treated with metformin HCl tablets and that were more common than in placebo-treated patients, are listed in Table 1.
• 3.Table 1: Adverse Reactions from a Clinical Trial of Metformin HCl Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus

6.2 Postmarketing Experience

• •The following adverse reactions have been identified during post approval use of metformin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• •Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.

7 DRUG INTERACTIONS

• 1.Table 2 presents clinically significant drug interactions with RIOMET.
• 2.Table 2: Clinically Significant Drug Interactions with RIOMET

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

• 1.Risk Summary
• 2.Limited data with RIOMET in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data]. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations].
• 3.No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5‑ times, respectively, a 2,550 mg clinical dose, based on body surface area [see Data].
• 4.The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20 to 25% in women with a HbA1C >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
• 5.Clinical Considerations
• 6.Disease-associated maternal and/or embryo/fetal risk
• 7.Poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
• 8.Data
• 9.Human Data
• 10.Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups.
• 11.Animal Data
• 12.Metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day. This represents an exposure of about 2 and 5 times a 2,550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin.

8.2 Lactation

• •Risk Summary
• •Limited published studies report that metformin is present in human milk [see Data]. However, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RIOMET and any potential adverse effects on the breastfed child from RIOMET or from the underlying maternal condition.
• •Data
• •Published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. However, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants.

8.3 Females and Males of Reproductive Potential

• •Discuss the potential for unintended pregnancy with premenopausal women as therapy with RIOMET may result in ovulation in some anovulatory women.

8.4 Pediatric Use

• 1.The safety and effectiveness of RIOMET for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old. Safety and effectiveness of RIOMET have not been established in pediatric patients less than 10 years old.
• 2.Use of RIOMET in pediatric patients 10 to 16 years old for the treatment of type 2 diabetes mellitus is supported by evidence from adequate and well-controlled studies of metformin HCl tablets in adults with additional data from a controlled clinical study of metformin HCl tablets in pediatric patients 10 to 16 years old with type 2 diabetes mellitus, which demonstrated a similar response in glycemic control to that seen in adults [see Clinical Studies (14)]. In this study, adverse reactions were similar to those described in adults. A maximum daily dose of 2,000 mg of RIOMET is recommended. [See Dosage and Administration (2.2).]

8.5 Geriatric Use

• 1.Controlled clinical studies of metformin HCl tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patients [see Warnings and Precautions (5.1)].

8.6 Renal Impairment

• •Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. RIOMET is contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2 [see Dosage and Administration (2.3), Contraindications (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)].

8.7 Hepatic Impairment

• •Use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. RIOMET is not recommended in patients with hepatic impairment. [see Warnings and Precautions (5.1)].

10 OVERDOSAGE

• •Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions (5.1)]. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

11 DESCRIPTION

RIOMET oral solution contains the biguanidine antihyperglycemic agent metformin in the form of monohydrochloride salt. Metformin hydrochloride, is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is shown as:

Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C 4H11N5•HCl and a molecular weight of 165.62. Metformin hydrochloride, USP 2.0 g is soluble in 20 mL of water. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. It is freely soluble in water; slightly soluble in alcohol; practically insoluble in acetone and in methylene chloride.

RIOMET (Cherry Flavor) contains 500 mg of metformin hydrochloride (the equivalent of 389.93 mg metformin) per 5 mL and the following inactive ingredients: Artificial cherry flavor, hydrochloric acid, potassium bicarbonate, purified water, saccharin calcium, and xylitol.

RIOMET (Strawberry Flavor) contains 500 mg of metformin hydrochloride (the equivalent of 389.93 mg metformin) per 5 mL and the following inactive ingredients: Hydrochloric acid, N&A strawberry flavor (propylene glycol and glycerin), potassium bicarbonate, purified water, sucralose, and xylitol.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

• •Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may decrease.

12.3 Pharmacokinetics

• 1.Two pharmacokinetic studies performed in healthy volunteers to evaluate the bioavailability of RIOMET in comparison with metformin HCl tablets under fasting and fed conditions showed that the rate and extent of absorption of RIOMET was found to be comparable to that of metformin HCl tablets under fasting or fed conditions (see Table 3).

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

• 1.Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 mg/kg/day and 1,500 mg/kg/day, respectively. These doses are both approximately 3 times the maximum recommended human daily dose of 2,550 mg based on body surface area comparisons. No evidence of carcinogenicity with metformin was found in either male or female mice. Similarly, there was no tumorigenic potential observed with metformin in male rats. There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day.
• 2.There was no evidence of a mutagenic potential of metformin in the following in vitro tests: Ames test (S. typhimurium), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes). Results in the in vivo mouse micronucleus test were also negative.
• 3.Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately 2 times the maximum recommended human daily dose of 2,550 mg based on body surface area comparisons.

14 CLINICAL STUDIES

• 1.Adult Clinical Studies
• 2.A double-blind, placebo-controlled, multicenter US clinical trial involving obese patients with type
• 3.2 diabetes mellitus whose hyperglycemia was not adequately controlled with dietary management alone (baseline fasting plasma glucose [FPG] of approximately 240 mg/dL) was conducted. Patients were treated with metformin HCl tablets (up to 2,550 mg/day) or placebo for 29 weeks. The results are presented in Table 8.
• 4.Table 8: Mean Change in Fasting Plasma Glucose and HbA1c at Week 29Comparing Metformin HCl Tablets vs Placebo in Patients with Type 2Diabetes Mellitus

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

• 1.RIOMET 500 mg per 5 mL (100 mg/mL) oral solution is supplied in bottles with child-resistant caps and a dosing cup as follows:

Storage

• 1.Store at 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

• 1.Advise the patient to read the FDA-approved patient labeling (Patient Information).
• 2.Administration:
• 3.Instruct patients or caregivers to use the supplied dosing cup to measure the prescribed amount of medication. Inform patients that additional RIOMET dosing cups or oral dosing syringes may be obtained from their pharmacy.
• 4.Lactic Acidosis:
• 5.Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue RIOMET immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur. Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving RIOMET. Instruct patients to inform their doctor that they are taking RIOMET prior to any surgical or radiological procedure, as temporary discontinuation may be required [see Warnings and Precautions (5.1)].
• 6.Hypoglycemia
• 7.Inform patients that hypoglycemia may occur when RIOMET is coadministered with oral sulfonylureas and insulin. Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions (5.3)].
• 8.Vitamin B12 Deficiency:
• 9.Inform patients about importance of regular hematological parameters while receiving RIOMET [see Warnings and Precautions (5.2)].
• 10.Females of Reproductive Age:
• 11.Inform females that treatment with RIOMET may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations (8.3)].
• 12.RIOMET is a registered trademark of Sun Pharmaceutical Industries Limited.
• 13.Manufactured by:
• 14.Mikart, LLC
• 15.Atlanta, GA 30318
• 16.Distributed by:
• 17.Sun Pharmaceutical Industries, Inc.
• 18.Cranbury, NJ 08512
• 19.November 2018 FDA-11

Patient Medication Information

• •PATIENT INFORMATION
• •RIOMET (ree oh met)
• •(metformin hydrochloride)
• •oral solution
• •What is the most important information I should know about RIOMET?
• •RIOMET can cause serious side effects, including:
• •Lactic Acidosis. Metformin hydrochloride, the medicine in RIOMET, can cause a rare, but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.
• •Stop taking RIOMET and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:

Package/Label Display Panel

NDC 10631-206-02

Riomet®

(metformin hydrochloride oral solution)

500 mg/5 mL

Each 5 mL contains: 500 mg of metformin hydrochloride, USP.

Cherry Flavor

Rx only

16 fl. oz.473 mL

Cherry Flavor