CONCERTA Methylphenidate hydrochloride 18 mg Tablet, Extended Release, 100-count
Other active recalls for Methylphenidate Hydrochloride (different manufacturers) — 1 · tap to view
🆔 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
- Methylphenidate helps boost two brain chemicals — dopamine and norepinephrine — that play a big role in attention, focus, and impulse control. When those chemicals are more availab...
- What exactly is methylphenidate supposed to do for my ADHD?
- Methylphenidate is a controlled substance, and it does have a real potential for abuse and dependence — that's something the FDA takes seriously enough to put a boxed warning on th...
- The most common ones — decreased appetite, some trouble sleeping, headache, and a slightly faster heartbeat — are annoying but usually manageable and tend to improve over time. For...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Methylphenidate Hydrochloride — tap one for details:
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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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BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
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Cellulose acetate is a plant-derived polymer made by chemically modifying cellulose fibers. In medications, it serves as a film-coating material for tablets and capsules to protect the drug, control release, and improve appearance.
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A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
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Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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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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Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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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.
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Succinic acid is an organic acid derived from natural sources or chemical synthesis. In medications, it functions as a buffer to help maintain the proper pH level and may also serve as a preservative or flavor enhancer in formulations.
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Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
15 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 | $12.329 | $1,232.94 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $12.54 | $1,253.85 / 100 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Methylphenidate Hydrochloride 18 mg 13811-0706-10 | Trigen | 100 tablets | $0.576 | AB | Availability likely | save 95% |
| Methylphenidate Hydrochloride 18 mg 31722-0952-01 | Camber | 100 tablets | $0.576 | AB | Availability likely | save 95% |
| Methylphenidate Hydrochloride 18 mg 50268-0545-12 | AvPAK | 1 tablet | $0.576 | AB | Discontinued | save 95% |
| Methylphenidate Hydrochloride 18 mg 60687-0532-21 | American | 1 tablet | $0.576 | AB | Availability likely | save 95% |
| Methylphenidate Hydrochloride 18 mg 62037-0725-01 | Actavis | 100 tablets | $0.576 | AB | Availability likely | save 95% |
| Methylphenidate Hydrochloride 18 mg 62175-0310-37 | Lannett | 100 tablets | $0.576 | BX | Availability likely | save 95% |
| Methylphenidate Hydrochloride 18 mg 00527-3310-37 | Lannett | 100 tablets | $0.736 | AB | FDA listed | save 94% |
| Methylphenidate Hydrochloride 18 mg 57664-0606-88 | Sun | 100 tablets | $0.736 | — | Discontinued | save 94% |
| Concerta 18 mgthis 50458-0585-01 | Janssen | 100 tablets | $12.329 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 18 mg 51407-0924-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Relexxii 18 mg 68025-0095-10 | Vertical | 100 tablets | — | — | FDA listed | — |
| Methylphenidate Hydrochloride 18 mg 72865-0133-01 | XLCare | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50458-0585-01 You're viewing this | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-585-01) | 2000-08-01 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION CONCERTA 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 CONCERTA, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with a higher dosage or unapproved methods of administration, such as snorting or injection. Before prescribing CONCERTA, assess each patient's risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of CONCERTA, and proper disposal of any unused drug. Throughout CONCERTA 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 Precautions (5.1) and Drug Abuse and Dependence (9.1 , 9.2) ]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning.
CONCERTA 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 CONCERTA, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing CONCERTA, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of CONCERTA, and proper disposal of any unused drug.
Throughout treatment, reassess each patient's risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) and Use in Specific Populations (8.4) ]. CONCERTA is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old.
( 1 ) Limitations of Use The use of CONCERTA is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to initiating CONCERTA treatment assess for ( 2.1 ): the presence of cardiac disease for family history of tics or Tourette' syndrome and clinically evaluate patients for motor or verbal tics or Tourette's syndrome Administer once daily in the morning with or without food. Swallow whole with liquids; do not chew, divide, or crush. ( 2.2 ) Recommended dosage in pediatric patients 6 to 17 years of age new to methylphenidate: starting dosage is18 mg once daily.
May be increased weekly in 18 mg increments. Maximum dosage for pediatric patients ( 2.3 ): 6 to 12 years: 54 mg once daily 13 to 17 years: 72 mg once daily Recommended dosage in adults (up to 65 years of age) new to methylphenidate: starting dosage is 18 mg or 36 mg once daily. May be increased weekly in 18 mg increments, up to 72 mg once daily.
( 2.3 ) Patients currently using immediate-release methylphenidate: starting CONCERTA dosage is based on current dosage regimen. ( 2.4 )
2.1Pretreatment Screening Prior to treating patients with CONCERTA, assess: For the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ]. The family history for tics or Tourette' syndrome and clinically evaluate patients for motor or verbal tics or Tourette's syndrome [see Warnings and Precautions (5.11) ].
2.2Important Administration Instructions Administer CONCERTA orally once daily in the morning with or without food. Swallow CONCERTA whole with liquids. Do not split, crush, or chew the extended-release tablets because doing so will compromise the extended-release characteristics of CONCERTA and may compromise the effectiveness or safety of CONCERTA.
2.3Recommended CONCERTA Dosage in Patients New to Methylphenidate See Table 1 for the recommended once-daily dosage of CONCERTA in patients who were not taking a methylphenidate product. In patients who have not achieved an optimal response at a lower dosage, increase the CONCERTA dosage in 18 mg increments at weekly intervals. However, if a slower titration is recommended for patients who have not achieved an optimal response taking 18 mg of CONCERTA once daily, increase their daily dosage to 27 mg once per day.
Table 1: Recommended CONCERTA Dosage in Patients New to Methylphenidate Patient Population Recommended Starting Dosage Dosage Range Pediatric patients 6 to 12 years of age 18 mg once daily 18 mg to 54 mg once daily Pediatric patients 13 to 17 years of age 18 mg once daily 18 mg to 72 mg once daily (not to exceed 2 mg/kg/day) Adults 18 to 65 years of age 18 or 36 mg once daily 18 mg to 72 mg once daily
2.4Recommended CONCERTA Dosage in Patients Switching from Another Methylphenidate Product See Table 2 for the recommended starting dosage of CONCERTA in patients switching from an immediate-release methylphenidate product administered twice daily or three times daily (total daily dosage of 10 to 60 mg/day). Table 2: Recommended Starting Dosage in Patients Switching from Another Methylphenidate Product Previous Immediate-release Methylphenidate Daily Dosage Recommended CONCERTA Starting Dosage 5 mg twice daily or three times daily 18 mg every morning 10 mg twice daily or three times daily 36 mg every morning 15 mg twice daily or three times daily 54 mg every morning 20 mg twice daily or three times daily 72 mg every morning Only for patients 13–65 years of age.
In patients who have not achieved an optimal response at a lower dosage, increase the CONCERTA dosage in 18 mg increments at weekly intervals. The maximum recommended dosage in pediatric patients 6 to 12 years of age is 54 mg/day, and the maximum recommended dosage in patients 13–65 years old is 72 mg/day.
2.5Dosage Reduction and Discontinuation If paradoxical aggravation of ADHD symptoms or CONCERTA-associated adverse reactions occur, reduce the CONCERTA dosage or, if necessary, discontinue CONCERTA. If ADHD improvement is n…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Extended-Release Tablets: 18 mg: yellow, imprinted with "alza 18" 27 mg: gray, imprinted with "alza 27" 36 mg: white, imprinted with "alza 36" 54 mg: brownish-red, imprinted with "alza 54" Extended-release tablets: 18, 27, 36, and 54 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS CONCERTA is contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of CONCERTA. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with CONCERTA. [see Adverse Reactions (6) ] . Receiving concomitant monoamine oxidase inhibitors (MAOIs), and within 14 days following discontinuation of treatment with a MAO inhibitor because of the risk of a hypertensive crisis [see Drug Interactions (7) ] .
Known hypersensitivity to methylphenidate or other components of CONCERTA ( 4 ) Receiving concomitant monoamine oxidase inhibitors and within 14 days following discontinuation of treatment with a MAO inhibitor ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ). Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse ( 5.3 ). Psychiatric Adverse Reactions : Prior to initiating CONCERTA, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing CONCERTA. ( 5.4 ) Priapism : If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention ( 5.5 ) Peripheral Vasculopathy, including Raynaud's Phenomenon : Carefully assess for digital changes during CONCERTA treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ) Long-Term Suppression of Growth in Pediatric Patients : Closely monitor growth (height and weight) in pediatric patients.
Pediatric patients not growing or gaining height or weight as expected may need to have their CONCERTA treatment interrupted. ( 5.7 ) Risk of Gastrointestinal (GI) Obstruction in Patients with GI Narrowing: Only use in patients able to swallow the extended-release tablet whole, and should not ordinarily be used in patients with pre-existing severe GI narrowing. ( 5.8 ) Acute Angle Closure Glaucoma: CONCERTA-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
( 5.9 ) Increased Intraocular Pressure (IOP) and Glaucoma : Prescribe CONCERTA to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor patients with a history of increased IOP or open angle glaucoma. ( 5.10 ) Motor and Verbal Tics, and Worsening of Tourette's Syndrome : Before initiating CONCERTA, assess the family history and clinically evaluate patients for tics or Tourette's syndrome.
Regularly monitor patients for the emergence or worsening of tics or Tourette's syndrome. Discontinue CONCERTA treatment if clinically appropriate. ( 5.11 )
5.1Abuse, Misuse, and Addiction CONCERTA has a high potential for abuse and misuse. The use of CONCERTA exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction [see Drug Abuse and Dependence (9.1 , 9.2) ] . Misuse and abuse of CNS stimulants, including CONCERTA, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher dosage or unapproved methods of administration, such as snorting or injection.
Before prescribing CONCERTA, 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 CONCERTA in a safe place, preferably locked, and instruct patients to not give CONCERTA to anyone else.
Throughout CONCERTA treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
5.2Risks 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 stimulants at the recommended ADHD dosage. Avoid CONCERTA use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
5.3Increased Blood Pressure and Heart Rate CNS stimulants may cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 beats per minute) [see Adverse Reactions (6) ] . Some patients may have larger increases. Monitor a…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) ] Hypersensitivity Reactions [see Contraindications (4) ] Monoamine Oxidase Inhibitors [see Contraindications (4) , Drug Interactions (7) ] 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) ] Priapism [see Warnings and Precautions (5.5) ] Peripheral Vasculopathy, including Raynaud's Phenomenon [see Warnings and Precautions (5.6) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.7) ] Risks of Gastrointestinal Obstruction in Patients with Gastrointestinal Narrowing [see Warnings and Precautions (5.8) ] Acute Angle Closure Glaucoma [see Warnings and Precautions (5.9) ] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.10) ] Motor and Verbal Tics, and Worsening of Tourette's Syndrome [see Warnings and Precautions (5.11) ] The most common adverse reactions (≥5%) in double-blind clinical trials were: Pediatric patients 6 to 17 years: upper abdominal pain.
( 6.1 ) Adults up to 65 years of age: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, tachycardia, and hyperhidrosis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial 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 clinical trials of another drug and may not reflect the rates observed in clinical practice. The data below is based on a total of 3,906 patients in clinical studies who received CONCERTA. Patients aged 6 up to 65 years old with ADHD were evaluated in 6 controlled clinical studies and 11 open-label clinical studies [see Table 3 ].
Table 3: CONCERTA-treated Patients in Double-Blind and Open-Label Clinical Studies Patient Population N Dosage Range Pediatric patients 6 to 12 years of age 2,216 18 to 54 mg once daily Adolescents 502 18 to 72 mg once daily Adults up to 65 years of age 1,188 18 to 108 mg once daily The most common adverse reactions (≥5%) in double-blind clinical trials were: Pediatric patients: upper abdominal pain [see Table 4 ] . Adults: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, tachycardia, and hyperhidrosis [see Table 5 ] .
The most common adverse reactions associated with CONCERTA discontinuation (≥1%) from the pediatric and adult clinical trials were anxiety, irritability, insomnia, and increased blood pressure . Most Common Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials: Adverse reactions in either the pediatric or adult double-blind adverse reactions tables may be relevant for both patient populations. Adverse Reactions in Pediatric Patients Aged 6 years and Older Table 4 displays adverse reactions reported in 2% or more of CONCERTA-treated pediatric patients ages 6 and older with ADHD in 4 placebo-controlled, double-blind clinical trials.
Table 4: Most Common Adverse Reactions Reported in ≥ 2% of CONCERTA-treated patients in Pediatric Patients 6 Years of Age and Older with ADHD in 4 Placebo-Controlled, Double-Blind Clinical Trials CONCERTA (n=321) Placebo (n=318) Upper abdominal pain 6% 4% Insomnia Initial insomnia (CONCERTA=0.6%) and insomnia (CONCERTA=2.2%) terms were combined into Insomnia. 3% 1% Nasopharyngitis 3% 2% Vomiting 3% 2% Pyrexia 2% 1% Adverse Reactions in Adults Table 5 lists the adverse reactions reported in 2% or more of CONCERTA-treated adults with ADHD in 2 pl…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 6 describes clinically significant drug interactions with CONCERTA. Table 6: Clinically Significant Drug Interactions Monoamine Oxidase Inhibitors Prevention or Management Concomitant use of CNS stimulants, including CONCERTA, with MAOIs or within 14 days after discontinuing an MAOI is contraindicated [ see Contraindications (4) ]. Mechanism and Clinical Effect(s) Concomitant use of MAOIs and CNS stimulants, including CONCERTA, can cause hypertensive crisis.
Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Antihypertensive Drugs Prevention or Management Increase monitoring for blood pressure and adjust the dosage of the antihypertensive drug, as needed. Mechanism and Clinical Effect(s) CONCERTA may decrease effectiveness of drugs used to treat hypertension [see Warnings and Precautions 5.3 ].
Halogenated Anesthetics Prevention or Management Avoid use of CONCERTA in patients being treated with anesthetics on the day of surgery. Mechanism and Clinical Effect(s) Concomitant use of halogenated anesthetics and CONCERTA may increase the risk of sudden blood pressure and heart rate increase during surgery. Risperidone Prevention or Management Monitor for signs of extrapyramidal symptoms.
Mechanism and Clinical Effect(s) The risk of risperidone-associated extrapyramidal symptoms may increase in patients taking concomitant CONCERTA when there is a change in the CONCERTA or risperidone dosage. Antihypertensive drugs : Monitor blood pressure. Adjust dosage of antihypertensive drug as needed.
( 7 ) See additional clinically significant drug interactions, in the DRUG INTERACTIONS section ( 7 ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Caution should be exercised if administered to nursing mothers (8.3) Safety and efficacy has not been established in children less than six years old or elderly patients greater than 65 years of age ( 8.4 and 8.5 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including CONCERTA, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ . Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of central nervous system (CNS) stimulants during pregnancy ( see Clinical Considerations ) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits throughout organogenesis at doses up to 4 and 16 times, respectively, the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 54 times the MRHD given to adults.
A slight decrease in body weight was observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD given to adults). In a pre- and postnatal development study in which rats were treated with oral administration of methylphenidate throughout pregnancy and lactation, a decrease in pup body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD given to adults on a mg/m 2 basis) (see Data ) . The background risk of major birth defects and miscarriage in those with ADHD is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions: CNS stimulants, such as CONCERTA, can cause vasoconstriction and thereby decrease placental perfusion.
No fetal and/or neonatal adverse reactions have been reported with the use of a therapeutic dosage of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine dependent mothers. Data Animal Data: In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses up to 30 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 54 times the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis.
The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times the MRHD given to adults on a mg/m 2 basis). There was no evidence of changes in morphological development in rats, although a reduction in maternal body weight was observed at the highest dose of 30 mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m 2 basis). The no effect level for maternal body weight in rats is 5 mg/day (equal to the MRHD for adults on a mg/m 2 basis); and the no effect level for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a mg/m 2 basis).
When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 30 mg/kg/day, decreases in offspring body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observe…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including CONCERTA, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ . Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of central nervous system (CNS) stimulants during pregnancy ( see Clinical Considerations ) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits throughout organogenesis at doses up to 4 and 16 times, respectively, the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 54 times the MRHD given to adults.
A slight decrease in body weight was observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD given to adults). In a pre- and postnatal development study in which rats were treated with oral administration of methylphenidate throughout pregnancy and lactation, a decrease in pup body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD given to adults on a mg/m 2 basis) (see Data ) . The background risk of major birth defects and miscarriage in those with ADHD is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions: CNS stimulants, such as CONCERTA, can cause vasoconstriction and thereby decrease placental perfusion.
No fetal and/or neonatal adverse reactions have been reported with the use of a therapeutic dosage of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine dependent mothers. Data Animal Data: In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses up to 30 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 54 times the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis.
The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times the MRHD given to adults on a mg/m 2 basis). There was no evidence of changes in morphological development in rats, although a reduction in maternal body weight was observed at the highest dose of 30 mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m 2 basis). The no effect level for maternal body weight in rats is 5 mg/day (equal to the MRHD for adults on a mg/m 2 basis); and the no effect level for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a mg/m 2 basis).
When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 30 mg/kg/day, decreases in offspring body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD of 72 mg/day, given to adults on a mg/m 2 basis). The no effect level for pre- and post-natal development in rats was 12.5 mg/kg/day (2 times the MRHD given to adults on a mg/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of CONCERTA for the treatment of ADHD have been established in pediatric patients 6 years of age and older. The safety and effectiveness of CONCERTA have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage.
Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth (weight and height) should be monitored in pediatric patients during treatment with CNS stimulants, including CONCERTA.
Pediatric patients who are not growing or gaining weight as expected may need to have their CONCERTA treatment interrupted [see Warnings and Precautions (5.7) ] . Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only.
The doses at which these findings were observed are at least 4 times the MRHD of 54 mg/day given to pediatric patients 6 to 12 years of age on a mg/m 2 basis. In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 54 mg/day given to pediatric patients 6 to 12 years of age on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (9 times the MRHD given to pediatric patients 6 to 12 years of age on a mg/m 2 basis).
The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.4 times the MRHD given to pediatric patients 6 to 12 years of age on a mg/m 2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.
🧓 Geriatric Use ▾
8.5Geriatric Use CONCERTA is not indicated for use in patients greater than 65 years of age.
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Clinical 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.
10.2Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of CONCERTA should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Methylphenidate is a central nervous system (CNS) stimulant. The mode of therapeutic action of methylphenidate in the treatment of ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of CONCERTA have not been fully characterized.
12.3Pharmacokinetics Absorption Following oral administration of CONCERTA, plasma methylphenidate concentrations reached an initial maximum concentration at about 1 hour, followed by gradual ascending concentrations over the next 5 to 9 hours, after which a gradual decrease begins. Mean times to reach peak plasma concentrations across all doses of CONCERTA occurred between 6 and 10 hours. CONCERTA once daily minimizes the fluctuations between peak and trough concentrations associated with immediate-release methylphenidate three times daily [ see Figure 1 ].
No clinically significant difference in methylphenidate exposures was observed following the administration of either CONCERTA once daily and immediate-release methylphenidate three times daily in adults. Figure 1. Mean Methylphenidate Plasma Concentrations Following a Single 18 mg CONCERTA dose and Immediate-release Methylphenidate 5 mg Doses (Three Doses Administered Every 4 Hours) The mean single-dose pharmacokinetic parameters in 36 healthy adults following the administration of one 18 mg CONCERTA dose and three 5 mg methylphenidate doses every four hours are summarized in Table 7.
Table 7: Methylphenidate Pharmacokinetic Parameters (Mean ± SD) After CONCERTA and Immediate-release Methylphenidate Dosing in Healthy Adults Parameters CONCERTA (18 mg single dose) (n=36) Immediate-release Methylphenidate (Three 5 mg doses every four hours) (n=35) C max (ng/mL) 3.7 ± 1.0 4.2 ±
1.0T max (h) 6.8 ± 1.8 6.5 ±
1.8AUC inf (ng∙h/mL) 41.8 ± 13.9 38.0 ± 11.0 t ½ (h) 3.5 ± 0.4 3.0 ±
0.5The methylphenidate pharmacokinetics were evaluated in healthy adults following single- and multiple-doses (steady state) of CONCERTA (up to 144 mg/day (up to 2 times the maximum recommended dose)). The mean half-life was about 3.6 hours. No differences in the pharmacokinetics of CONCERTA were noted following single and repeated once-daily CONCERTA dosing, indicating no significant drug accumulation.
The AUC and t 1/2 following repeated once-daily dosing are similar to those following a single 18 to 144 mg dose of CONCERTA. Dose Proportionality Following administration of CONCERTA in single doses of 18, 36, and 54 mg/day to healthy adults, C max and AUC (0–inf) of d-methylphenidate were dose proportional, whereas l-methylphenidate C max and AUC (0–inf) increased disproportionately with respect to dose. Following administration of CONCERTA, plasma concentrations of the l-isomer were approximately 1/40 the plasma concentrations of the d-isomer.
In healthy adults, single and multiple doses (once-daily) CONCERTA doses from 54 to 144 mg/day resulted in linear and dose-proportional increases in C max and AUC inf for total methylphenidate (MPH) and its major metabolite, α-phenyl-piperidine acetic acid (PPAA). There was no time dependency in the pharmacokinetics of methylphenidate. The ratio of metabolite (PPAA) to parent drug (MPH) was constant across doses from 54 to 144 mg/day, both after single dose and upon multiple dosing.
In a multiple-dose study, after patients aged 13 to 16 with ADHD were administered their prescribed CONCERTA dose (18 to 72 mg/day), mean C max and AUC TAU of d- and total methylphenidate increased proportionally with respect to dose. Food Effects: In patients, there were no differences in either the pharma…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Methylphenidate is a central nervous system (CNS) stimulant. The mode of therapeutic action of methylphenidate in the treatment of ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING CONCERTA ® (methylphenidate hydrochloride) extended-release tablets are available in 18 mg, 27 mg, 36 mg, and 54 mg strengths: 18 mg: yellow and imprinted with "alza 18", 100-count bottle (NDC 50458-585-01) 27 mg: gray and imprinted with "alza 27", 100-count bottle (NDC 50458-588-01) 36 mg: white and imprinted with "alza 36", 100-count bottle (NDC 50458-586-01) 54 mg: brownish-red and imprinted with "alza 54", 100-count bottle (NDC 50458-587-01) Storage and Handling Store at 25 °C (77 °F); excursions permitted to 15–30 °C (59–86 °F) [see USP Controlled Room Temperature] .
Protect from humidity.
📦 Storage and Handling ▾
Storage and Handling Store at 25 °C (77 °F); excursions permitted to 15–30 °C (59–86 °F) [see USP Controlled Room Temperature] . Protect from humidity.
📋 Description ▾
11 DESCRIPTION CONCERTA ® is a central nervous system (CNS) stimulant. CONCERTA is available in four strengths. Each extended-release tablet for oral administration contains 18, 27, 36, or 54 mg of methylphenidate hydrochloride, USP.
Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride, its empirical formula is C 14 H 19 NO 2 ∙HCl, and its structural formula is: Methylphenidate hydrochloride, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.
Its molecular weight is 269.77. CONCERTA also contains the following inactive ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin. It is possible that CONCERTA extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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 CONCERTA, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.1 , 9.2) , Overdosage (10) ]. Advise patients to store CONCERTA in a safe place, preferably locked, and instruct patients to not give CONCERTA 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 CONCERTA 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 Advise patients and their caregivers that CONCERTA can cause elevations in blood pressure and heart rate [see Warnings and Precautions (5.3) ].
Psychiatric Risks Advise patients and their caregivers that CONCERTA, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4) ]. Priapism Advise patients, caregivers, and family members of CONCERTA-treated males of the possibility of priapism. Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5) ] .
Peripheral Vasculopathy, including Raynaud's Phenomenon Instruct patients about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms; to report to their health care provider any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes; to call their health care provider immediately with any signs of unexplained wounds appearing on fingers or toes while taking CONCERTA [see Warnings and Precautions (5.6) ] . Long-term Suppression of Growth in Pediatric Patients Advise patients, caregivers, and family members that CONCERTA may cause slowing of growth and weight loss in pediatric patients [see Warnings and Precautions (5.7) ] .
Glaucoma and Increased Intraocular Pressure Advise patients that increased intraocular pressure and glaucoma may occur during CONCERTA treatment [see Warnings and Precautions (5.10) ] . 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 CONCERTA treatment. 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 (5.11) ] .
Administration Instructions Instruct patients to swallow CONCERTA whole with liquids, and not to split, crush, or chew, the extended-release tablets. Advise patients not to be concerned if they occasionally notice a tablet-appearing substance in their stool. Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CONCERTA during pregnancy [see Use in Specific Populations (8.1) ] .
Lactation Advise CONCERTA-treated breastfeeding women to monitor their infants for agitation, poor sleeping patterns, changes in feeding, and reduced weight gain [see Use in Specific Populations (8.2) ] .
💬 Medication Guide ▾
MEDICATION GUIDE CONCERTA ® (kon SER-ta) (methylphenidate hydrochloride) extended-release tablets for oral use, CII This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 02/2026 What is the most important information I should know about CONCERTA?
CONCERTA may cause serious side effects, including: Abuse, misuse, and addiction. CONCERTA has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of CONCERTA, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death.
The risk of overdose and death is increased with higher doses of CONCERTA 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 CONCERTA and will monitor you or your child during treatment. CONCERTA may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
Do not give CONCERTA to anyone else. See " What is CONCERTA? " for more information. Keep CONCERTA in a safe place and properly dispose of any unused medicine.
See " How should I store CONCERTA? " 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 CONCERTA. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
Call your healthcare provider 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 CONCERTA. Increased blood pressure and heart rate. Your healthcare provider should check your or your child's blood pressure and heart rate regularly during treatment with CONCERTA.
Mental (psychiatric) problems, including: new or worse behavior or 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 CONCERTA, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
See " What are the possible side effects of CONCERTA? " for more information about side effects . What is CONCERTA? CONCERTA is a central nervous system (CNS) stimulant prescription medicine used for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 to 65 years of age.
CONCERTA may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. CONCERTA is not recommended for use in children under 6 years of age with ADHD. CONCERTA is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs .
Keep CONCERTA in a safe place to protect it from theft. Never give your CONCERTA to anyone else because it may cause death or harm them. Selling or giving away CONCERTA may harm others and is against the law.
Who should not take CONCERTA? Do not take CONCERTA if you or your child are: allergic to methylphenidate or any of the ingredients in CONCERTA. See the end of this Medication Guide for a complete list of ingredients in CONCERTA. taking, or have stopped taking within the past 14 days, a medicine called a mo…