Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate.

Structural Formula:

Dextroamphetamine sulfate, USP is a colorless, bubble gum flavored oral solution. Each 5 mL (1 teaspoonful) of dextroamphetamine sulfate oral solution contains 5 mg of dextroamphetamine sulfate. Inactive ingredients consist of anhydrous citric acid, benzoic acid, bubble gum flavor, purified water, sodium citrate anhydrous, sodium saccharin, and sorbitol solution.

Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.

There is neither specific evidence that clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Dextroamphetamine sulfate oral solution is indicated in:

Narcolepsy

Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crisis may result).

Abuse, Misuse, and Addiction

Dextroamphetamine sulfate has a high potential for abuse and misuse. The use of dextroamphetamine sulfate exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dextroamphetamine sulfate can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE and DEPENDENCE). Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing dextroamphetamine sulfate, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give dextroamphetamine sulfate to anyone else. Throughout dextroamphetamine sulfate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Risks to Patients with Serious Cardiac Disease

Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who are treated with CNS stimulants at the recommended ADHD dosages.

Avoid Dextroamphetamine Sulfate Oral Solution use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

Increased Blood Pressure and Heart Rate 

CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.

Psychiatric Adverse Reactions

Exacerbation of Pre-Existing Psychosis: CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder: CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms: CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing dextroamphetamine sulfate.

Long-Term Suppression of Growth in Pediatric Patients: CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients, including dextroamphetamine sulfate. Closely monitor growth (weight and height) in Dextroamphetamine Sulfate Oral Solution-treated pediatric patients treated with CNS stimulants.

Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted (see PRECAUTIONS, PEDIATRIC USE).

Seizures: There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Peripheral Vasculopathy, Including Raynaud’s Phenomenon: Stimulants, including dextroamphetamine sulfate oral solution, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulcerations and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at the therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during dextroamphetamine sulfate oral solution-treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for dextroamphetamine sulfate oral solution-treated patients who develop signs or symptoms of peripheral vasculopathy.

Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort (see DRUG INTERACTIONS).

The coadministration with cytochrome P450 (CYP2D6) inhibitors may also increase the risk with increased exposure to dextroamphetamine sulfate oral solution. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 (see DRUG INTERACTIONS).

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Concomitant use of dextroamphetamine sulfate oral solution with MAOI drugs is contraindicated (see CONTRAINDICATIONS).

Discontinue treatment with dextroamphetamine sulfate oral solution and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of dextroamphetamine sulfate oral solution  with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate dextroamphetamine sulfate oral solution with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

CNS stimulants, including amphetamine sulfate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Assess the family history and clinically evaluate patients for tics or Tourette’s syndrome before initiating dextroamphetamine sulfate. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome with dextroamphetamine sulfate, and discontinue treatment if clinically appropriate.

MAO Inhibitors - MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.

Serotonergic Drugs - The concomitant use of dextroamphetamine sulfate oral solution and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine sulfate oral solution initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate oral solution and the concomitant serotonergic drug(s) (see WARNINGS, PRECAUTIONS). Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort.

CYP2D6 Inhibitors - The concomitant use of dextroamphetamine sulfate oral solution and CYP2D6 inhibitors may increase the exposure of dextroamphetamine sulfate oral solution compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during dextroamphetamine sulfate oral solution initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate oral solution and the CYP2D6 inhibitor (see WARNINGS, OVERDOSAGE). Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.

 Acidifying Agents – Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.

Adrenergic Blockers – Adrenergic blockers are inhibited by amphetamines.

Alkalinizing Agents – Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of amphetamines.

Antidepressants, Tricyclic – Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

Antihistamines – Amphetamines may counteract the sedative effect of antihistamines.

Antihypertensives – Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine – Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.

Ethosuximide – Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol – Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.

Lithium Carbonate – The stimulatory effects of amphetamines may be inhibited by lithium carbonate.

Meperidine – Amphetamines potentiate the analgesic effect of meperidine.

Methenamine Therapy – Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.

Norepinephrine – Amphetamines enhance the adrenergic effect of norepinephrine.

Phenobarbital – Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.

Phenytoin – Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.

Propoxyphene – In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Veratrum Alkaloids – Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and verbal tics and Tourette’s syndrome.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic: Urticaria.

Endocrine: Impotence, changes in libido.

Musculoskeletal: Rhabdomyolysis.

To report SUSPECTED ADVERSE REACTIONS, contact Cranbury Pharmaceuticals, LLC at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Clinical Effects of Overdose

Overdose of CNS stimulants is characterized by the following sympathomimetic effects:

• Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.
• CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur.
• Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.

Overdose Management

Consider the possibility of multiple drug ingestion. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.

Narcolepsy: Usual dose is 5 mg to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate oral solution may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Attention Deficit Disorder with Hyperactivity: Not recommended for pediatric patients under 3 years of age.

In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.

Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Prior to treating patients with dextroamphetamine sulfate 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).
• the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome (see WARNINGS).

Dextroamphetamine Sulfate Oral Solution 5 mg/5 mL is a colorless, bubble gum flavored oral solution. It is available in 16 fluid ounces (473 mL) bottles, NDC 27808-085-01.

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Manufactured by

Tris Pharma, Inc.

Monmouth Junction, NJ 08852

For:

Cranbury Pharmaceuticals, LLC

Monmouth Junction, NJ 08852

LB8255

Rev.10

Revised: 08/2024

Dextroamphetamine Sulfate Oral Solution, CII 5 mg/5 mL

(DEX-troe-am-FET-a-meen SUL-fate)

Rx Only

What is Dextroamphetamine Sulfate Oral Solution?

Dextroamphetamine Sulfate Oral Solution is a central nervous system (CNS) stimulant prescription medicine used for the treatment of:

• a sleep disorder called narcolepsy.
• Attention-Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age.
• Dextroamphetamine Sulfate Oral Solution may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Dextroamphetamine Sulfate Oral Solution is safe and effective in children under 6 years of age.

Dextroamphetamine Sulfate Oral Solution is a federally controlled substance (CII) because it contains dextroamphetamine that can be a target for people who abuse prescription medicines or street drugs.  Keep Dextroamphetamine Sulfate Oral Solution in a safe place to protect it from theft. Never give your Dextroamphetamine Sulfate Oral Solution to anyone else because it may cause death or harm them. Selling or giving away Dextroamphetamine Sulfate Oral Solution may harm others, and is against the law.

 Do not take Dextroamphetamine Sulfate Oral Solution if you or your child:

• are allergic to amphetamine products or any of the ingredients in Dextroamphetamine Sulfate Oral Solution. See the end of this Medication Guide for a complete list of ingredients in Dextroamphetamine Sulfate Oral Solution.
• are taking or have taken within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or the intravenous medicine methylene blue.

Before taking Dextroamphetamine Sulfate Oral Solution, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:

• have heart problems, heart disease, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have seizures or have had an abnormal brain wave test (EEG)
• have circulation problems in fingers and toes
• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
• are pregnant or plan to become pregnant. It is not known if Dextroamphetamine Sulfate Oral Solution will harm the unborn baby. Tell your healthcare provider if you or your child become pregnant during treatment with Dextroamphetamine Sulfate Oral Solution.
• are breastfeeding or plan to breastfeed. Dextroamphetamine Sulfate Oral Solution passes into breast milk. You or your child should not breastfeed during treatment with Dextroamphetamine Sulfate Oral Solution. Talk to your healthcare provider about the best way to feed the baby during treatment with Dextroamphetamine Sulfate Oral Solution.

Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Dextroamphetamine Sulfate Oral Solution and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with Dextroamphetamine Sulfate Oral Solution. Your healthcare provider will decide if Dextroamphetamine Sulfate Oral Solution can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

• selective serotonin reuptake inhibitors (SSRIs)
• medicines used to treat migraine headaches called triptans
• lithium
• tramadol
• buspirone
• serotonin norepinephrine reuptake inhibitors (SNRIs)
• tricyclic antidepressants
• fentanyl
• tryptophan
• St. John’s Wort

Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

Do not start any new medicine during treatment with Dextroamphetamine Sulfate Oral Solution without talking to your healthcare provider first.

How should Dextroamphetamine Sulfate Oral Solution be taken?

•  Take Dextroamphetamine Sulfate Oral Solution exactly as prescribed by your or your child’s healthcare provider.
• Your healthcare provider may change the dose if needed.
•  Dextroamphetamine Sulfate Oral Solution is usually taken two to three times a day. The first dose is usually taken in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.

If you or your child take too much Dextroamphetamine Sulfate Oral Solution, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking Dextroamphetamine Sulfate Oral Solution?

Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how Dextroamphetamine Sulfate Oral Solution affects you.

What are possible side effects of Dextroamphetamine Sulfate Oral Solution?

Dextroamphetamine Sulfate Oral Solution may cause serious side effects, including:

See “What is the most important information I should know about Dextroamphetamine Sulfate Oral Solution?”

• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Dextroamphetamine Sulfate Oral Solution. Your healthcare provider may stop your child’s Dextroamphetamine Sulfate Oral Solution treatment if they are not growing or gaining weight as expected.

• Seizures. Your healthcare provider may stop treatment with Dextroamphetamine Sulfate Oral Solution if you or your child have a seizure.

• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon).
  Signs and symptoms may include:

• fingers or toes may feel numb, cool, painful

• fingers or toes may change color from pale, to blue, to red

Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Dextroamphetamine Sulfate Oral Solution.

•  New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with Dextroamphetamine Sulfate Oral Solution.
•  Serotonin syndrome. This problem may happen when Dextroamphetamine Sulfate Oral Solution is taken with certain other medicines and may be life-threatening. Stop taking Dextroamphetamine Sulfate Oral Solution and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome:

• agitation
• fast heartbeat
• flushing
• seizures
• coma
• sweating
• loss of coordination
• confusion
• dizziness
• tremors, stiff muscles, or muscle twitching
• seeing or hearing things that are not real (hallucination)
• changes in blood pressure
• high body temperature (hypothermia)
• nausea, vomiting, diarrhea

The most common side effects of Dextroamphetamine Sulfate Oral Solution include:

• fast heartbeat
• decreased appetite
• tremors
• headache
• trouble sleeping
• dizziness
• stomach upset
• weight loss
• dry mouth

These are not all of the possible side effects of Dextroamphetamine Sulfate Oral Solution. 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 Dextroamphetamine Sulfate Oral Solution?

• Store Dextroamphetamine Sulfate Oral Solution at room temperature between 68° to 77°F (20° to 25°C). 
• Store Dextroamphetamine Sulfate Oral Solution in a safe place, like a locked cabinet. Protect from light.
• Dispose of remaining, unused, or expired Dextroamphetamine Sulfate Oral Solution by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no takeback program or DEA authorized collector is available, mix Dextroamphetamine Sulfate Oral Solution with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Dextroamphetamine Sulfate Oral Solution in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Keep Dextroamphetamine Sulfate Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of Dextroamphetamine Sulfate Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dextroamphetamine Sulfate Oral Solution for a condition for which it was not prescribed. Do not give Dextroamphetamine Sulfate Oral Solution to other people, even if they have the same symptoms that you or your child have. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about Dextroamphetamine Sulfate Oral Solution that is written for health professionals. 

For more information about Dextroamphetamine Sulfate Oral Solution, please contact Cranbury Pharmaceuticals, LLC at 1-732-940-0358 or go to https://www.cranburypharma.com/products/.

What are the ingredients in Dextroamphetamine Sulfate Oral Solution?

Active ingredient: dextroamphetamine sulfate

Inactive ingredients: anhydrous citric acid, benzoic acid, bubble gum flavor, purified water, sodium citrate anhydrous, sodium saccharin, and sorbitol solution.

Manufactured by:
Tris Pharma, Inc.
Monmouth Junction, NJ 08852

For:
Cranbury Pharmaceuticals, LLC
Monmouth Junction, NJ 08852

LB8256

Rev. 07

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 08/2024

Dispense with Medication Guide available at: https://www.cranburypharma.com/products/

Dextroamphetamine Sulfate Oral Solution CII

5 mg/ 5 mL

16 fl. oz. (473 mL)

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only