COMMON USES: This medicine is a stimulant combination used to treat attention-deficit hyperactivity disorder (ADHD). This medicine may also be used to treat other conditions as determined by your doctor.
HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine may be taken on an empty stomach or with food. Take this medicine in the morning soon after you wake up or as directed by your doctor. Avoid taking this medicine in the afternoon to decrease trouble sleeping at night, unless your doctor tells you differently. SWALLOW WHOLE. Do not break, chew, or crush before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. DO NOT crush or chew the medicine before swallowing. DO NOT store the mixture for future use. CERTAIN FOODS AND MEDICINES can affect the amount of acid in your stomach and intestines. This can increase or decrease (depending on the medicine) the absorption of this medicine. DO NOT TAKE ANTACIDS (eg, calcium carbonate) or certain alkalinizing agents (eg, sodium bicarbonate) with this medicine without first talking with your doctor. They may increase the risk of side effects of this medicine. Tell your doctor if you take any of these products: fruit juice, ascorbic acid (vitamin C), ammonium chloride, sodium acid phosphate, ulcer medicines (eg, H2 blockers, such as famotidine and ranitidine; proton pump inhibitors / PPIs, such as omeprazole and lansoprazole), methenamine, or acetazolamide. STORE THIS MEDICINE at room temperature, 77 degrees F (25 degrees C), in a tightly-closed container, away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as you remember if it is in the morning. If it is past noon, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.
CAUTIONS: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or to similar medicines, or are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may cause serious side effects or may be habit-forming. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval. When used for an extended period of time, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. Laboratory and/or medical tests, including blood pressure, pulse, and heart tests, may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS. Make sure laboratory personnel and your doctors know you take this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. This medicine may cause drowsiness, dizziness, or blurred vision. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE MAY CAUSE increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period. AVOID LARGE AMOUNTS OF caffeine-containing foods and beverages (eg, coffee, tea, cocoa, cola drinks, chocolate). SERIOUS EFFECTS, INCLUDING HEART ATTACK, STROKE, AND SUDDEN DEATH, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious problem, talk with your doctor about other therapies to treat your condition. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes medicines containing a decongestant. This medicine may affect growth rate and weight gain in CHILDREN AND TEENAGERS in some cases. They may need regular growth and weight checks while they take this medicine. FOR WOMEN: This medicine may cause harm to the fetus. IF YOU THINK YOU MAY BE PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.
POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include constipation; diarrhea; dizziness; dry mouth; headache; loss of appetite; nausea; nervousness; restlessness; stomach pain or upset; trouble sleeping; unpleasant taste; vomiting; weakness; or weight loss. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blurred vision or other vision problems; change in sexual ability or desire; chest, jaw, or arm pain; confusion; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; new or worsening mental, mood, or behavior problems (eg, abnormal thoughts, aggression, agitation, anxiety, delusions, depression, hostility); one-sided weakness; painful or frequent urination; red, swollen, peeling, or blistered skin; seizures; severe or persistent headache; severe stomach pain; severe weight loss; shortness of breath; sudden, severe nausea or vomiting; slurred speech; uncontrolled muscle movement; unusual sweating; or unusual weakness or tiredness. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately.
ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.