Rescon

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use this medication if you are allergic to dexchlorpheniramine or pseudoephedrine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• a blockage in your stomach or intestines;

• kidney or liver disease;

• high blood pressure, heart disease, coronary artery disease, or recent heart attack;

• enlarged prostate or urination problems;

• glaucoma;

• diabetes;

• epilepsy or other seizure disorder;

• pheochromocytoma (an adrenal gland tumor);

• overactive thyroid; or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether dexchlorpheniramine and pseudoephedrine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

It is not known whether dexchlorpheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Rescon for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Avoid drinking alcohol while taking Rescon.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Use with care in children. Talk with the doctor.
• Different brands of this medicine may be for use in different ages of children. Talk with the doctor before giving Rescon to a child.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
• If you think there has been an overdose, call 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room (ER) right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Rescon or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Rescon. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

calcium phosphate dibasic, lactose monohydrate, magnesium stearate, methylcellulose, microcrystalline cellulose, Povidone, Prosolv SMCC 90, sodium starch glycolate, FD&C Blue #1, D&C Red # 30, D&C Yellow #10.

This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy.

Sympathomimetic amines in overdosage may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage.

Antihistamines should be used with considerable caution in pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. Antihistamines may cause excitability, especially in children.

At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage. Heat prostration can occur with methscopolamine used where the environmental temperature is high.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, use of methscopolamine would be inappropriate and possibly harmful.

This product is comprised of pharmacologically different components (sympathomimetic amine, antihistamine, anticholinergic). Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual. Reaction to an overdose of this product may vary from CNS depression to stimulation. A description of symptoms which are likely to appear after ingestion of an excess of the individual components follows:

∙ Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage and pulmonary edema. It can also cause palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, and hallucination. ∙ Manifestation of antihistamine overdosage may vary from CNS depression to stimulation. Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension. Stimulation is particularly likely in children as are atropine-like signs and symptoms (dry mouth, fixed, dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms). In infants and children particularly, antihistamines, in overdosage may produce convulsion and/or death. ∙ The signs and symptoms of overdosage of anticholinergics are headache, nausea, vomiting, blurred vision, fixed and dilated pupils, hot dry skin, dizziness, dryness of mouth, difficulty in swallowing and CNS stimulation. Treatment of acute overdosage would probably be based upon treating the patient for phenylephrine toxicity which may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness, and insomnia. Other effects may include hyperpyrexia, hypertension, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor, or respiratory depression. Arrhythmias may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather than a depletion of potassium. No organ damage or significant metabolic derangement is associated with overdosage.

General Treatment: Treatment is symptomatic and supportive with possible utilization of the following:

∙ Induction of emesis (syrup of Ipecac recommended); however, precaution against aspiration is necessary, especially in infants and children. ∙ Gastric lavage (isotonic or 0.45% sodium chloride solution) if patient is unable to vomit within three hours of ingestion. ∙ Saline cathartics (milk of magnesia) may be used. ∙ Vasopressors to treat hypotension; however, epinephrine should not be used since it may further lower blood pressure. ∙ For excessive hypertensive effect an α-adrenergic blocker, such as phentolamine, may be administered. ∙ Hyperpyrexia, especially in children, may require treatment by means of external cooling. ∙ Excessive CNS stimulation may be counteracted with parenteral diazepam. ∙ Oxygen and intravenous fluids. ∙ Precaution against the use of stimulants (analeptic agents) is recommended because they may cause seizures. ∙ Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100 - 200 mL of a 2% solution) by rectal infusion. In severe cases of overdosage it is essential to monitor both the heart (by electrocardiograph) and plasma electrolytes, and to give intravenous potassium as indicated. In the event of progression of the curare-like effect to paralysis of the respiratory muscles or apnea, artificial respiration should be instituted and maintained until effective respiratory action returns.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.