Methylin™ methylphenidate HCI oral solution, is a mild central nervous system (CNS) stimulant, available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl ?-phenyl-2-piperidineacetate hydrochloride, and its structural formula is

Methylphenidate Hydrochloride
C₁₄H₁₉NO₂•HCI    MW = 269.77

Methylphenidate hydrochloride USP is a white, odorless, fine 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.

Each mL of Methylin™ Oral Solution (methylphenidate hcl oral solution 5 mg/5 ml and 10 mg/5 ml) 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP.

Each mL of Methylin™ Oral Solution (methylphenidate hcl oral solution 5 mg/5 ml and 10 mg/5 ml) 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP.

In addition, Methylin™ Oral Solution (methylphenidate hcl oral solution 5 mg/5 ml and 10 mg/5 ml) also contains the following inactive ingredients: citric acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified water.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: uncontrolled movements (motor tics or tremor), verbal tics (e.g., Tourette's syndrome), weight loss, fast/pounding/irregular heartbeat, mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, abnormal thoughts), difficulty urinating.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, chest pain, jaw/left arm pain, fainting, seizures, vision changes, weakness on one side of the body, slurred speech, confusion.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain mental/mood conditions (e.g., agitation, psychosis), heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, severe anxiety/tension, glaucoma, motor tics.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family history of sudden death, family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), high blood pressure (hypertension), heart disease (e.g., heart failure, recent heart attack, abnormal heart rhythm), overactive thyroid (hyperthyroidism), seizures, verbal tics (diagnosis or family history of Tourette's syndrome).

This drug may make you dizzy, lightheaded, (rarely) drowsy, or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Though uncommon, depression itself can lead to thoughts or attempts of suicide. If you are being treated for depression, tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes. Keep all medical appointments so your doctor can monitor your progress closely.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Children younger than 6 years may be at greater risk for the side effects of this medication.

This drug may affect your child's growth rate, weight, and final adult height, especially in children younger than 6 years. To reduce the risk, the doctor may recommend temporarily stopping the medication from time to time. Check your child's weight and height, and consult your doctor or pharmacist for more details.

Methylphenidate should be used during pregnancy only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if methylphenidate passes into breast milk. Consult your doctor before breast-feeding.