Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg Tablet, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
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🏭 Manufacturer & labeler
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🩺 Clinical
The combination of dextroamphetamine and amphetamine (Adderall®, Adderall® XR, Mydayis®) is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age). Adderall® is used to treat ADHD in adults and children 3 years of age and older. Adderall® XR is used to treat ADHD in adults and children 6 years of age and older. Mydayis® is used to treat ADHD in adults and children 13 years of age and older. Dextroamphetamine and amphetamine (Add...
Read the full MedlinePlus article ↗- It helps your brain maintain higher levels of two key signaling chemicals — dopamine and norepinephrine. In people with ADHD, those chemical signals can be inconsistent, making it...
- What exactly is this medication supposed to do for ADHD?
- The most common ones, especially at first, are reduced appetite, trouble falling asleep, and sometimes a stomachache or headache. These often improve after your body adjusts to the...
- What side effects should I actually expect when I first start taking it?
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.237 | $23.70 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.4487 | $44.87 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.5376 | $53.76 / 100 tablets |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00406-8885-01 You're viewing this | 100 TABLET in 1 BOTTLE (0406-8885-01) | 2003-10-07 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION Mixed Salts of a Single Entity Amphetamine Product has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Mixed Salts of a Single Entity Amphetamine Product, 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 Mixed Salts of a Single Entity Amphetamine Product, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout Mixed Salts of a Single Entity Amphetamine Product treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction ( see WARNINGS and DRUG ABUSE AND DEPENDENCE ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Mixed Salts of a Single Entity Amphetamine Product are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV ® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home.
The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive.
The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia. Attention Deficit Hyperactivity Disorder Not recommended for children under 3 years of age.
In children 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 children 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 Mixed Salts of a Single Entity Amphetamine Product 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 before initiating Mixed Salts of a Single Entity Amphetamine Product ( see WARNINGS ).
Narcolepsy Usual dose 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 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.
⛔ Contraindications ▾
CONTRAINDICATIONS In patients known to be hypersensitive to amphetamine, or other components of Mixed Salts of a Single Entity Amphetamine Product. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products ( see ADVERSE REACTIONS ). Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis ( see WARNINGS and DRUG INTERACTIONS ) .
⚠️ Warnings ▾
WARNINGS Abuse, Misuse, and Addiction Mixed Salts of a Single Entity Amphetamine Product has a high potential for abuse and misuse. The use of Mixed Salts of a Single Entity Amphetamine Product exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Mixed Salts of a Single Entity Amphetamine Product can be diverted for non-medical use into illicit channels or distribution ( see DRUG ABUSE AND DEPENDENCE, Abuse ).
Misuse and abuse of CNS stimulants, including Mixed Salts of a Single Entity Amphetamine Product, 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 Mixed Salts of a Single Entity Amphetamine Product, 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 Mixed Salts of a Single Entity Amphetamine Product to anyone else. Throughout Mixed Salts of a Single Entity Amphetamine Product 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 were treated with CNS stimulant treatment at the recommended ADHD dosages.
Avoid Mixed Salts of a Single Entity Amphetamine Product 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). Some patients may have larger increases.
Monitor all Mixed Salts of a Single Entity Amphetamine Product-treated patients for potential tachycardia and hypertension. Psychiatric Adverse Reactions Exacerbation of Preexisting Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting 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 Mixed Salts of a Single Entity Amphetamine Product. Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in Mixed Salts of a Single Entity Amphetamine Product-treated pediatric patients treated with CNS stimulants.
Pediatric patients who are not growing or gaining 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 seizure, in patients with prior EEG abnormalities in absence of seizures, and very rarely, in patients without a history of…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Cardiovascular Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania.
Eye Disorders Vision blurred, mydriasis. 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, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Endocrine Impotence, changes in libido, frequent or prolonged erections.
Skin Alopecia. Musculoskeletal Rhabdomyolysis.
🔄 Drug Interactions ▾
Drug Interactions MAO Inhibitors Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer Mixed Salts of a Single Entity Amphetamine Product concomitantly or within 14 days after discontinuing MAOI ( see CONTRAINDICATIONS and WARNINGS ).
Serotonergic Drugs The concomitant use of Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product initiation or dosage increase. If serotonin syndrome occurs, discontinue Mixed Salts of a Single Entity Amphetamine Product and the concomitant serotonergic drug(s) ( see WARNINGS and PRECAUTIONS ).
CYP2D6 Inhibitors The concomitant use of Mixed Salts of a Single Entity Amphetamine Product and CYP2D6 inhibitors may increase the exposure of Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Mixed Salts of a Single Entity Amphetamine Product and the CYP2D6 inhibitor ( see WARNINGS and OVERDOSAGE ).
Acidifying Agents Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents and urinary acidifying agents.
Adrenergic Blockers Adrenergic blockers are inhibited by amphetamines. Alkalinizing Agents Increase blood levels and potentiate the action of amphetamine. Co-administration of Mixed Salts of a Single Entity Amphetamine Product and gastrointestinal alkalinizing agents should be avoided.
Examples of alkalinizing agents include gastrointestinal alkalinizing agents and urinary alkalinizing agents. Tricyclic Antidepressants May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response.
Antihistamines Amphetamines may counteract the sedative effect of antihistamines. Antihypertensives Amphetamines may antagonize the hypotensive effects of antihypertensives. Chlorpromazine Chlorpromazine blocks dopamine and norepinephrine receptors, 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 receptors, thus inhibiting the central stimulant effects of amphetamines. Lithium Carbonate The anorectic and 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; coadministration of phenobarbital may produce a synergistic anticonvulsant action. Phenytoin Amphetamines may delay intestinal absorption of phenytoin; coadministration of phenytoin may produce a synergistic anticonvulsant action. Propoxyphene In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.
Proton Pump Inhibitors Time to maximum concentration (T max ) of amphetamine is decreased compared to wh…
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Amphetamine, in the enantiomer ratio present in Mixed Salts of a Single Entity Amphetamine Product (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m 2 body surface area basis.
Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 6 times that of a human dose of 30 mg/day [child] on a mg/m 2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity. A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations.
Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy.
Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.
🧒 Pediatric Use ▾
Pediatric Use Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder described under INDICATIONS AND USAGE .
🧓 Geriatric Use ▾
Geriatric Use Mixed Salts of a Single Entity Amphetamine Product have not been studied in the geriatric population.
🆘 Overdosage ▾
OVERDOSAGE 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.
O verdose 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacodynamics Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Pharmacokinetics Mixed Salts of a Single Entity Amphetamine Product contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of Mixed Salts of a Single Entity Amphetamine Product to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine. The mean elimination half-life (t ½ ) for d-amphetamine was shorter than the t ½ of the l-isomer (9.77 to 11 hours vs.
11.5to 13.8 hours). The PK parameters (C max , AUC 0-inf ) of d- and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics. The effect of food on the bioavailability of Mixed Salts of a Single Entity Amphetamine Product has not been studied.
Metabolism and Excretion Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain α or β carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid.
Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility. Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated.
In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made. With normal urine pHs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine and approximately another 30% to 40% of the dose is recoverable in urine as amphetamine itself.
Since amphetamine has a pKa of 9.9, urinary recovery of amphetamine is highly dependent on pH and urine flow rates. Alkaline urine pHs result in less ionization and reduced renal elimination, and acidic pHs and high flow rates result in increased renal elimination with clearances greater than glomerular filtration rates, indicating the involvement of active secretion. Urinary recovery of amphetamine has been reported to range from 1% to 75%, depending on urinary pH, with the remaining fraction of the dose hepatically metabolized.
Consequently, both hepatic and renal dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. In addition, drugs that affect urinary pH are known to alter the elimination of amphetamine, and any decrease in amphetamine’s metabolism that might occur due to drug interactions or genetic polymorphisms is more likely to be clinically significant when renal elimination is decreased ( see PRECAUTIONS ).
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) are supplied as follows: 5 mg: White to cream colored/mottled pillow shaped tablet, debossed with a “5” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8891-01 7.5 mg: White to cream colored/mottled pillow shaped tablet, debossed with a “7.5” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8884-01 10 mg: White to cream colored/mottled pillow shaped tablet, debossed with a “10” and a partial quadrisect on one side and a on the other side.
Bottles of 100….NDC 0406-8892-01 15 mg: White to cream colored/mottled octagon shaped tablet, debossed with a “15” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8885-01 20 mg: White to cream colored/mottled octagon shaped tablet, debossed with a “20” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8893-01 30 mg: White to cream colored/mottled octagon shaped tablet, debossed with a “30” and a partial quadrisect on one side and a on the other side.
Bottles of 100….NDC 0406-8894-01 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and are trademarks of a Mallinckrodt company. © 2025 Mallinckrodt.
DSM-IV is the trademark of its owner. Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA Rev 09/2025 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20D11.pdf or by calling 1-800-778-7898 for alternate delivery options. Mallinckrodt Mallinckrodt Mallinckrodt Mallinckrodt Mallinckrodt Mallinckrodt Mallinckrodt
📋 Description ▾
DESCRIPTION A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. EACH TABLET CONTAINS 5 mg 7.5 mg 10 mg 15 mg 20 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 1.875 mg 2.5 mg 3.75 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate 1.25 mg 1.875 mg 2.5 mg 3.75 mg 5 mg 7.5 mg Dextroamphetamine Sulfate USP 1.25 mg 1.875 mg 2.5 mg 3.75 mg 5 mg 7.5 mg Amphetamine Sulfate USP 1.25 mg 1.875 mg 2.5 mg 3.75 mg 5 mg 7.5 mg Total Amphetamine Base Equivalence 3.13 mg 4.7 mg 6.3 mg 9.4 mg 12.6 mg 18.8 mg Inactive Ingredients: Microcrystalline cellulose, silicon dioxide, povidone, and stearic acid.
Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 30 mg are white to cream colored/mottled tablets, which contain no color additives.
💬 Information for Patients ▾
Information for Patients 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 Mixed Salts of a Single Entity Amphetamine Product, which can lead to overdose and death, and proper disposal of any unused drug ( see WARNINGS , DRUG ABUSE AND DEPENDENCE , OVERDOSAGE ). Advise patients to store Mixed Salts of a Single Entity Amphetamine Product in a safe place, preferably locked, and instruct patients to not give Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product 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 ). Increased Blood Pressure and Heart Rate Advise patients that Mixed Salts of a Single Entity Amphetamine Product can elevate blood pressure and heart rate ( see WARNINGS ).
Psychiatric Adverse Reactions Advise patients that Mixed Salts of a Single Entity Amphetamine Product, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania ( see WARNINGS ). Long-Term Suppression of Growth in Pediatric Patients Advise patients that Mixed Salts of a Single Entity Amphetamine Product may cause slowing of growth including weight loss ( see WARNINGS ). Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] Instruct patients beginning treatment with Mixed Salts of a Single Entity Amphetamine Product 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 color 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 Mixed Salts of a Single Entity Amphetamine Product. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
Serotonin Syndrome Caution patients about the risk of serotonin syndrome with concomitant use of Mixed Salts of a Single Entity Amphetamine Product 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 , WARNINGS , and DRUG INTERACTIONS ).
Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome. 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 Mixed Salts of a Single Entity Amphetamine Product. Instruct the patients to notify their healthcare provider if emergence or worsening of tics or Tourette’s syndrome occurs ( see WARNINGS ).
💬 Medication Guide ▾
MEDICATION GUIDE MEDICATION GUIDE Dextroamphetamine Saccharate Amphetamine Aspartate Dextroamphetamine Sulfate Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), CII (dex” troe am fet' a meen sac cha rate, am fet' a meen a spar' tate, dex” troe am fet' a meen sul' fate, am fet' a meen sul' fate) What is the most important information I should know about Mixed Salts of a Single Entity Amphetamine Product? Mixed Salts of a Single Entity Amphetamine Product may cause serious side effects, including: Abuse, misuse, and addiction.
Mixed Salts of a Single Entity Amphetamine Product has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Mixed Salts of a Single Entity Amphetamine Product, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Mixed Salts of a Single Entity Amphetamine Product or when it is used in ways that are not approved, such as snorting or injection.
Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with Mixed Salts of a Single Entity Amphetamine Product and will monitor you or your child during treatment. Mixed Salts of a Single Entity Amphetamine Product may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Mixed Salts of a Single Entity Amphetamine Product to anyone else.
See “ What is Mixed Salts of a Single Entity Amphetamine Product? ” for more information. Keep Mixed Salts of a Single Entity Amphetamine Product in a safe place and properly dispose of any unused medicine. See “ How should I store Mixed Salts of a Single Entity Amphetamine Product? ” for more information.
Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease : Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with Mixed Salts of a Single Entity Amphetamine Product.
Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Mixed Salts of a Single Entity Amphetamine Product. Increased blood pressure and heart rate.
Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Mixed Salts of a Single Entity Amphetamine Product. Mental (psychiatric) problems, including: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Mixed Salts of a Single Entity Amphetamine Product, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What are Mixed Salts of a Single Entity Amphetamine Product? Mixed Salts of a Single Entity Amphetamine Product are a central nervous system (CNS) stimulant prescription medicine used for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in children 3 to 17 years of age.
Mixed Salts of a Single Entity Amphetamine Product may help increase attention and decrease impulsiveness and hyperactivity i…