Lisdexamfetamine Dimesylate

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Prior to treatment, assess for presence of cardiac disease ( 2.4 ) Severe renal impairment:
• Maximum dose is 50 mg/day ( 2.5 ) End stage renal disease (ESRD):
• Maximum dose is 30 mg/day ( 2.5 )
• 2.1 Pre-treatment Screening Prior to treating patients with lisdexamfetamine dimesylate, assess:
• for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ]. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating lisdexamfetamine dimesylate [see Warnings and Precautions (5.8) ].
• 2.2 General Administration Information Take lisdexamfetamine dimesylate orally in the morning with or without food;
• avoid afternoon doses because of the potential for insomnia.
• Lisdexamfetamine dimesylate may be administered in one of the following ways:
• Information for lisdexamfetamine dimesylate capsules:
• Swallow lisdexamfetamine dimesylate capsules whole, or Open capsules, empty and mix the entire contents with yogurt, water, or orange juice.
• If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder.
• The contents should be mixed until completely dispersed.
• Consume the entire mixture immediately .
• It should not be stored.
• The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed.
• Information for lisdexamfetamine dimesylate chewable tablets:
• Lisdexamfetamine dimesylate chewable tablets must be chewed thoroughly before swallowing.
• Lisdexamfetamine dimesylate capsules can be substituted with lisdexamfetamine dimesylate chewable tablets on a unit per unit/mg per mg basis (for example, 30 mg capsules for 30 mg chewable tablet) [see Clinical Pharmacology ( 12.3 ) ].
• Do not take anything less than one capsule or chewable tablet per day.
• A single dose should not be divided.
• Dosage for Treatment of ADHD The recommended starting dosage in
• adults and pediatric patients 6 years and older is 30 mg once daily in the morning.
• Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum recommended dosage of 70 mg once daily [see Clinical Studies ( 14.1 )] .
• Dosage for Treatment of Moderate to Severe BED in
• Adults The recommended starting dosage in
• adults is 30 mg once daily to be titrated in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50 mg to 70 mg once daily.
• The maximum recommended dosage is 70 mg once daily [see Clinical Studies ( 14.2 )] .
• Discontinue lisdexamfetamine dimesylate if binge eating does not improve.
• 2.5 Dosage in Patients with Renal Impairment In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m 2 ), the maximum dosage should not exceed 50 mg once daily.
• In patients with end stage renal disease (ESRD, GFR < 15 mL/min/1.73 m 2 ), the maximum recommended dosage is 30 mg once daily [see Use in Specific Populations ( 8.6 )] .
• 2.6 Dosage Modifications due to Drug Interactions Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine.
• Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels.
• Adjust lisdexamfetamine dimesylate dosage accordingly [see Drug Interactions ( 7.1 )] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• The safety and effectiveness of lisdexamfetamine dimesylate have not been established in pediatric patients below the age of 6 years.
• ADHD Safety and effectiveness of lisdexamfetamine dimesylate have been established in pediatric patients with ADHD ages 6 to 17 years [see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )] .
• Safety and efficacy of lisdexamfetamine dimesylate were evaluated in a double-blind, randomized, parallel-group, placebo-controlled, fixed-dose study in pediatric patients ages 4 to 5 years with ADHD, followed by a 1-year open-label extension study.
• In these studies, patients experienced elevated rates of adverse reactions, including weight loss, decreased BMI, decreased appetite, insomnia, infections (upper respiratory and nasopharyngitis), irritability, and affect lability.
• With the same lisdexamfetamine dimesylate dose, mean steady state exposure of dextroamphetamine was approximately 44% higher in pediatric patients ages 4 to 5 years compared to the pediatric patients ages 6 to 11 years.
• BED Safety and effectiveness of lisdexamfetamine dimesylate have not been established in pediatric patients with BED less than 18 years of age.
• Growth Suppression Growth should be monitored during treatment with stimulants, including lisdexamfetamine dimesylate, and pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.1 )] .
• Juvenile Animal Data Studies conducted in juvenile rats and dogs at clinically relevant doses showed growth suppression that partially or fully reversed in dogs and female rats but not in male rats after a four-week drug-free recovery period.
• A study was conducted in which juvenile rats received oral doses of 4, 10, or 40 mg/kg/day of lisdexamfetamine dimesylate from day 7 to day 63 of age.
• These doses are approximately 0.3, 0.7, and 3 times the maximum recommended human daily dose of 70 mg on a mg/m 2 basis for a child.
• Dose-related decreases in food consumption, bodyweight gain, and crown-rump length were seen; after a four-week drug-free recovery period, bodyweights and crown-rump lengths had significantly recovered in females but were still substantially reduced in males.
• Time to vaginal opening was delayed in females at the highest dose, but there were no drug effects on fertility when the animals were mated beginning on day 85 of age.
• In a study in which juvenile dogs received lisdexamfetamine dimesylate for 6 months beginning at 10 weeks of age, decreased bodyweight gain was seen at all doses tested (2, 5, and 12 mg/kg/day, which are approximately 0.5, 1, and 3 times the maximum recommended human daily dose on a mg/m 2 basis for a child).
• This effect partially or fully reversed during a four- week drug-free recovery period.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of lisdexamfetamine dimesylate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
• Other reported clinical experience and pharmacokinetic data [see Clinical Pharmacology ( 12.3 )] have not identified differences in responses between the elderly and younger patients.
• In general, dose selection for an elderly patient should start 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following adverse reactions are discussed in greater detail in other sections of the labeling:
• Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets [see Contraindications ( 4 )] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )] Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), and Drug Abuse and Dependence ( 9.2 , 9.3 )] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions ( 5.2 )] Increased Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.4 )] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions ( 5.5 )] Peripheral Vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions ( 5.6 )] Serotonin Syndrome [see Warnings and Precautions ( 5.7 )] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥ 5% and at a rate at least twice placebo) in pediatric patients ages 6 to 17 years, and/or
• adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting ( 6.1 ) Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in
• adults with BED were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience 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.
• Attention Deficit Hyperactivity Disorder The safety data in this section is based on data from the 4-week controlled parallel-group clinical studies of lisdexamfetamine dimesylate in pediatric and adult patients with ADHD [see Clinical Studies ( 14.1 )] .
• Adverse Reactions Associated with Discontinuation of Treatment in ADHD Clinical Trials In the controlled trial in pediatric patients ages 6 to 12 years (Study 1), 8% (18/218) of lisdexamfetamine dimesylate-treated patients discontinued due to adverse reactions compared to 0% (0/72) of placebo-treated patients.
• The most frequently reported adverse reactions (1% or more and twice rate of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, decreased appetite and rash [2 instances for each adverse reaction, i.e., 2/218 (1%)].
• Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included abdominal pain upper, dry mouth, weight decreased, dizziness, somnolence, logorrhea, chest pain, anger and hypertension.
• In the controlled trial in pediatric patients ages 13 to 17 years (Study 4), 3% (7/233) of lisdexamfetamine dimesylate-treated patients discontinued due to adverse reactions compared to 1% (1/77) of placebo-treated patients.
• The most frequently reported adverse reactions (1% or more and twice rate of placebo) were decreased appetite (2/233; 1%) and insomnia (2/233; 1%).
• Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included irritability, dermatillomania, mood swings, and dyspnea.
• In the controlled adult trial (Study 7), 6% (21/358) of lisdexamfetamine dimesylate-treated patients discontinued due to adverse reactions compared to 2% (1/62) of placebo-treated patients.
• The most frequently reported adverse reactions (1% or more and twice rate of placebo) were insomnia (8/358; 2%), tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%).
• Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included palpitations, diarrhea, nausea, decreased appetite, dizziness, agitation, depression, paranoia and restlessness.
• Adverse Reactions Occurring at an Incidence of ≥5% or More Among Lisdexamfetamine Dimesylate-Treated Patients with ADHD in Clinical Trials The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) reported in pediatric patients ages 6 to 17 years, and/or
• adults were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.
• Adverse Reactions Occurring at an Incidence of 2% or More Among Lisdexamfetamine Dimesylate Treated Patients with ADHD in Clinical Trials Adverse reactions reported in the controlled trials in pediatric patients ages, 6 to 12 years (Study 1), pediatric patients ages 13 to 17 years (Study 4), and adult patients (Study 7) treated with lisdexamfetamine dimesylate or placebo are presented in Tables 1, 2and 3 below.
• Table 1 Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 6 to 12 Years with ADHD Taking Lisdexamfetamine Dimesylate and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 1) Table 2 Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 13 to 17 Years with ADHD Taking Lisdexamfetamine Dimesylate and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 4) Table 3 Adverse Reactions Reported by 2% or More of Adult Patients with ADHD Taking Lisdexamfetamine Dimesylate and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 7) In addition, in the adult population erectile dysfunction was observed in 2.6% of males on lisdexamfetamine dimesylate and 0% on placebo; decreased libido was observed in 1.4% of subjects on lisdexamfetamine dimesylate and 0% on placebo.
• Weight Loss and Slowing Growth Rate in Pediatric Patients with ADHD In a controlled trial of lisdexamfetamine dimesylate in pediatric patients ages 6 to 12 years (Study 1), mean weight loss from baseline after 4 weeks of therapy was -0.9, -1.9, and -2.5 pounds, respectively, for patients receiving 30 mg, 50 mg, and 70 mg of lisdexamfetamine dimesylate, compared to a 1 pound weight gain for patients receiving placebo.
• Higher doses were associated with greater weight loss with 4 weeks of treatment.
• Careful follow-up for weight in pediatric patients ages 6 to 12 years who received lisdexamfetamine dimesylate over 12 months suggests that consistently medicated pediatric patients (i.e., treatment for 7 days per week throughout the year) have a slowing in growth rate, measured by body weight as demonstrated by an age- and sex-normalized mean change from baseline in percentile, of -13.4 over 1 year (average percentiles at baseline and 12 months were 60.9 and 47.2, respectively).
• In a 4-week controlled trial of lisdexamfetamine dimesylate in pediatric patients ages 13 to 17 years, mean weight loss from baseline to endpoint was -2.7, -4.3, and -4.8 lbs., respectively, for patients receiving 30 mg, 50 mg, and 70 mg of lisdexamfetamine dimesylate, compared to a 2 pound weight gain for patients receiving placebo.
• Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients ages 7 to 13 years (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.
• In a controlled trial of amphetamine (d- to l-enantiomer ratio of 3:1) in pediatric patients ages 13 to 17 years, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 pounds and -2.8 pounds, respectively, for patients receiving 10 mg and 20 mg of amphetamine.
• Higher doses were associated with greater weight loss within the initial 4 weeks of treatment [see Warnings and Precautions ( 5.5 )] .
• Weight Loss in
• Adults with ADHD In the controlled adult trial (Study 7), mean weight loss after 4 weeks of therapy was 2.8 pounds, 3.1 pounds, and 4.3 pounds, for patients receiving final doses of 30 mg, 50 mg, and 70 mg of lisdexamfetamine dimesylate, respectively, compared to a mean weight gain of 0.5 pounds for patients receiving placebo.
• Binge Eating Disorder The safety data in this section is based on data from two 12-week parallel group, flexible-dose, placebo-controlled studies in
• adults with BED [see Clinical Studies ( 14.2 )] .
• Patients with cardiovascular risk factors other than obesity and smoking were excluded.
• Adverse Reactions Associated with Discontinuation of Treatment in BED Clinical Trials In controlled trials of patients ages 18 to 55 years, 5.1% (19/373) of lisdexamfetamine dimesylate-treated patients discontinued due to adverse reactions compared to 2.4% (9/372) of placebo-treated patients.
• No single adverse reaction led to discontinuation in 1% or more of lisdexamfetamine dimesylate-treated patients.
• Less commonly reported adverse reactions (less than 1% or less than twice rate of placebo) included increased heart rate, headache, abdominal pain upper, dyspnea, rash, insomnia, irritability, feeling jittery and anxiety.
• Adverse Reactions Occurring at an Incidence of 5% or More and At Least Twice Placebo Among Lisdexamfetamine Dimesylate Treated Patients with BED in Clinical Trials The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) reported in
• adults were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.
• Adverse Reactions Occurring at an Incidence of 2% or More and At Least Twice Placebo Among Lisdexamfetamine Dimesylate Treated Patients with BED in Clinical Trials Adverse reactions reported in the pooled controlled trials in adult patients (Study 11 and 12) treated with lisdexamfetamine dimesylate or placebo are presented in Table 4 below.
• Table 4 Adverse Reactions Reported by 2% or More of Adult Patients with BED Taking Lisdexamfetamine Dimesylate and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in 12-Week Clinical Trials (Study 11 and 12) 1 Includes all preferred terms containing the word “insomnia.” 2 Includes the preferred terms “heart rate increased” and “tachycardia.” table 1 table 2 table 3 table 4
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of lisdexamfetamine dimesylate.
• 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.
• These events are as follows:
• cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, motor and verbal tics, bruxism, depression, dermatillomania, alopecia, aggression, Stevens-Johnson Syndrome, chest pain, angioedema, urticaria, seizures, libido changes, frequent or prolonged erections, constipation, rhabdomyolysis, and intestinal ischemia.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Medication Guide).
• Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of lisdexamfetamine dimesylate, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2), Overdosage (10)].
• Advise patients to store lisdexamfetamine dimesylate in a safe place, preferably locked, and instruct patients to not give lisdexamfetamine dimesylate to anyone else.
• Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with lisdexamfetamine dimesylate use.
• Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2) ].
• Increased Blood Pressure and Heart Rate Instruct patients that lisdexamfetamine dimesylate can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects.
• Psychiatric Adverse Reactions Advise patients that lisdexamfetamine dimesylate at recommended doses may cause psychotic or manic symptoms even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4) ].
• Long-Term Suppression of Growth in Pediatric Patients Advise patients that lisdexamfetamine dimesylate may cause slowing of growth including weight loss [see Warnings and Precautions (5.5) ].
• Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] Instruct patients beginning treatment with lisdexamfetamine dimesylate about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms:
• fingers or toes may feel numb, cool, painful, and/or may change from pale, to blue, to red.
• Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
• Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking lisdexamfetamine dimesylate.
• Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6) ].
• Serotonin Syndrome Caution patients about the risk of serotonin syndrome with concomitant use of lisdexamfetamine dimesylate and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St.
• John’s Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications (4) , Warnings and Precautions (5.7) and Drug Interactions (7.1) ].
• Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.
• Concomitant Medications Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1) ].
• Advise patient or caregiver of steps to take with lisdexamfetamine dimesylate when a laboratory imaging procedure is ordered [see Drug Interactions (7.2)].
• Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with lisdexamfetamine dimesylate.
• Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.8) ].
• Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lisdexamfetamine dimesylate during pregnancy [see Use in Specific Populations (8.1) ].
• Pregnancy Advise patients of the potential fetal effects from the use of lisdexamfetamine dimesylate during pregnancy.
• Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with lisdexamfetamine dimesylate [see Use in Specific Populations (8.1) ].
• Lactation Advise women not to breastfeed if they are taking lisdexamfetamine dimesylate [see Use in Specific Populations (8.2) ].
• Administration Instructions Capsules:
• Advise patients to take the capsules whole or empty and mix the entire contents with yogurt, water, or orange juice.
• Advise patients to consume the mixture immediately and not to store for future use [see Dosage and Administration (2.2) ].
• Chewable tablets:
• Advise patients that chewable tablets must be chewed thoroughly before swallowing [see Dosage and Administration (2.2) ].
• All trademarks are the property of their respective owners.
• Manufactured by: Ohm Laboratories Inc.
• New Brunswick, NJ 08901 Distributed by: Sun Pharmaceutical Industries, Inc.
• Cranbury, NJ 08512 Rev. 05/2026 5272659

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Lisdexamfetamine Dimesylate Capsules:
• Capsules 10 mg:
• Pink opaque cap/pink opaque body (imprinted with 'RM46' on cap and '10 mg' on body).
• Capsules 20 mg:
• Off white opaque cap /off white opaque body (imprinted with 'RM47' on cap and '20 mg' on body).
• Capsules 30 mg:
• Orange opaque cap/white opaque body (imprinted with 'RM48' on cap and '30 mg' on body).
• Capsules 40 mg:
• Dark green opaque cap/white opaque body (imprinted with 'RM49' on cap and '40 mg' on body).
• Capsules 50 mg:
• Blue opaque cap/white opaque body (imprinted with 'RM50' on cap and '50 mg' on body).
• Capsules 60 mg:
• Aqua blue opaque cap/aqua blue opaque body (imprinted with 'RM51' on cap and '60 mg' on body).
• Capsules 70 mg:
• Blue opaque cap/orange opaque body (imprinted with 'RM52' on cap and '70 mg' on body).
• Lisdexamfetamine Dimesylate Chewable Tablets:
• Chewable tablets 10 mg:
• White to off-white round shaped tablet debossed with ‘10’ on one side and ‘S83’ on the other side Chewable tablets 20 mg:
• White to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S84’ on the other side Chewable tablets 30 mg:
• White to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S85’ on the other side Chewable tablets 40 mg:
• White to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S86’ on the other side Chewable tablets 50 mg:
• White to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S87’ on the other side Chewable tablets 60 mg:
• White to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S88’ on the other side Capsules:
• 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg ( 3 ) Chewable tablets:
• 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Lisdexamfetamine Dimesylate Capsules:
• Lisdexamfetamine dimesylate capsules 10 mg:
• White to off-white powder filled in pink opaque cap and pink opaque body imprinted with 'RM46' on cap and '10 mg' on body in black ink, bottles of 100 CRC, NDC 57664-046-88 Lisdexamfetamine dimesylate capsules 20 mg:
• White to off-white powder filled in off white opaque cap and off white opaque imprinted with 'RM47' on cap and '20 mg' on body in black ink, bottles of 100 CRC, NDC 57664-047-88 Lisdexamfetamine dimesylate capsules 30 mg:
• White to off-white powder filled in orange opaque cap and white opaque body imprinted with 'RM48' on cap and '30 mg' on body in black ink, bottles of 100 CRC, NDC 57664-048-88 Lisdexamfetamine dimesylate capsules 40 mg:
• White to off-white powder filled dark green opaque cap and white opaque body imprinted with 'RM49' on cap and '40 mg' on body in black ink, bottles of 100 CRC, NDC 57664-049-88 Lisdexamfetamine dimesylate capsules 50 mg:
• White to off-white powder filled in blue opaque cap and white opaque body imprinted with 'RM50' on cap and '50 mg' on body in black ink, bottles of 100 CRC, NDC 57664-050-88 Lisdexamfetamine dimesylate capsules 60 mg:
• White to off-white powder filled in aqua blue opaque cap and aqua blue opaque body imprinted with 'RM51' on cap and '60 mg' on body in black ink, bottles of 100 CRC, NDC 57664-051-88 Lisdexamfetamine dimesylate capsules 70 mg:
• White to off-white powder filled in blue opaque cap and orange opaque body imprinted with 'RM52' on cap and '70 mg' on body in black ink, bottles of 100 CRC, NDC 57664-052-88 Lisdexamfetamine Dimesylate Chewable Tablets:
• Lisdexamfetamine dimesylate chewable tablets 10 mg:
• White to off-white round shaped tablet debossed with ‘10’ on one side and ‘S83’ on the other side, bottles of 100 CRC, NDC 57664-083-88 Lisdexamfetamine dimesylate chewable tablets 20 mg:
• White to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S84’ on the other side, bottles of 100 CRC, NDC 57664-084-88 Lisdexamfetamine dimesylate chewable tablets 30 mg:
• White to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S85’ on the other side, bottles of 100 CRC, NDC 57664-085-88 Lisdexamfetamine dimesylate chewable tablets 40 mg:
• White to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S86’ on the other side, bottles of 100 CRC, NDC 57664-086-88 Lisdexamfetamine dimesylate chewable tablets 50 mg:
• White to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S87’ on the other side, bottles of 100 CRC, NDC 57664-087-88 Lisdexamfetamine dimesylate chewable tablets 60 mg:
• White to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S88’ on the other side, bottles of 100 CRC, NDC 57664-088-88
• 16.2 Storage and Handling Dispense in a tight, light-resistant container as defined in the USP.
• Store at room temperature 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature] .

Quoted from the official label, section “How Supplied”.

What is in it

• Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets, a CNS stimulants, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S )-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15 H 25 N 3 O
• (CH 4 O 3 S) 2 , which corresponds to a molecular weight of 455.60. The chemical structure is:
• Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules:
• Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients:
• black iron oxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells also contain one or more of the following:
• FD&C Red #3, D&C Red #28, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, and yellow iron oxide. Information for Lisdexamfetamine Dimesylate Chewable Tablets:
• Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients:
• colloidal silicon dioxide, corn maltodextrin, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, propylene glycol, sucralose, strawberry flavor. Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

159 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Lisdexamfetamine Dimesylate