Deconsal® DM Tannate Chewable Tablets are an antihistamine/nasal decongestant/antitussive combination for oral administration as a chewable tablet. Each Deconsal® DM Tannate Chewable Tablet in a grape-flavored, dye-free, mottled brown-colored, scored tablet for oral administration contains:

Phenylephrine HCl.................10 mg
Pyrilamine Maleate................16 mg
Dextromethorphan HBr...........15 mg

Inactive ingredients: Citric acid, calcium phosphate dibasic, hypromellose, grape flavor, magnesium aluminum silicate, magnesium stearate, compressible sugar, corn starch, mannitol, sucralose, talc, tannic acid, and xanthan gum.

See DOSAGE AND ADMINISTRATION section for further descriptive composition.

Last updated on RxList: 5/4/2009

Deconsal® DM Tannate Chewable Tablets are indicated for the symptomatic relief of coryza, nasal congestion, and cough associated with the common cold, sinusitis, allergic rhinitis, and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease.

Deconsal® DM Tannate Chewable Tablets: Administer the recommended dose every 12 hours. 12 years and older - 1 to 2 tablets; 6 to 12 years of age - !4 to 1 tablet.

Deconsal® DM Tannate Chewable Tablets are available as grape-flavored, dye-free, mottled brown-colored, scored tablet imprinted with CT on one side and the score line on the other

NDC No.: 10122-203-10 - Bottles of 100 Chewable Tablets and NDC No.: 10122-203-02 single tablet sample pouches.

Store at controlled room temperature, 20°-25° C (68° -77° F). Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure. Protect from moisture.

Manufactured for: Cornerstone BioPharma, Inc. Cary, NC 27518.

Last updated on RxList: 5/4/2009

The most common effects associated with antihistamines have been drowsiness sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines, sympathomimetics, and antitussives have been rare. Other adverse reactions may include:

Dermatologic - urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular - hypotension, hypertension, cardiac arrhythmias, palpitations.

Central Nervous Systems (CNS) - disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria.

Genitourinary - urinary frequency, difficult urination.

Gastrointestinal - epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation. Respiratory - tightness of the chest and wheezing, shortness of breath. Hematologic - hemolytic anemia, thrombocytopenia, agranulocytosis.

MAO inhibitors may prolong and intensify the anticholinergic effects of sympathomimetic agents. Patients may develop hyperpyrexia, hypotension, nausea, myoclonic leg jerks, and coma following coadministration of MAO inhibitors and dextromethorphan. Thus, concomitant administration of Deconsal® DM Tannate Chewable Tablets and MAO inhibitors should be avoided (see "CONTRAINDICATIONS").

Last updated on RxList: 5/4/2009

This product contains an antihistamine that may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Antihistamines should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.

General

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients and therefore should be used with caution. Antihistamines may cause excitation, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, or narrow angle glaucoma.

Dextromethorphan should be used with caution in sedated patients, and in patients confined to the supine position.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term animal studies have been performed with Deconsal® DM Tannate Chewable Tablets.

Pregnancy

Teratogenic Effects- Pregnancy Category C

Animal reproduction studies have not been conducted with Deconsal® DM Tannate Chewable Tablets. It is also not known whether Deconsal® DM Tannate Chewable Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Deconsal® DM Tannate Chewable Tablets should be given to a pregnant woman only if clearly needed.

Labor and Delivery

Administration of phenylephrine to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Deconsal® DM Tannate Tablets should not be administered to a nursing mother.

Last updated on RxList: 5/4/2009

Signs And Symptoms

May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent. Dextromethorphan may produce central excitement and mental confusion. Very high doses of dextromethorphan may produce respiratory depression.

Treatment

Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children, and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.

Deconsal® DM Tannate Chewable Tablets are contraindicated in patients sensitive to any of the ingredients or related compounds. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds).

Deconsal® DM Tannate Chewable Tablets should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see "PRECAUTIONS-DRUG INTERACTIONS").

Last updated on RxList: 5/4/2009

Deconsal® DM Tannate Chewable Tablets combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of pyrilamine and the antitussive effect of dextromethorphan.

Phenylephrine

Phenylephrine is a decongestant which is a potent post synaptic a-receptor agonist with little effect on p receptors of the heart. A direct action at the receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Phenylephrine has no effect on p-adrenergic receptors of the bronchi or peripheral blood vessels. Phenylephrine has a mild stimulant effect.

Pyrilamine

Pyrilamine is an antihistamine, Hi receptor blocking agent belonging to the ethylenediamine class of antihistamines. Hi-blocking drugs inhibit the actions of histamine on smooth muscle, capillary permeability, and can both stimulate and depress the central nervous system. Pyrilamine also possesses anticholinergic and sedative properties.

Dextromethorphan

Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity.

Last updated on RxList: 5/4/2009

Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery, while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase (MAO) inhibitor (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAO inhibitor drug. If patients are uncertain whether a prescription drug contains an MAO inhibitor, they should be instructed to consult a health professional before taking this product.

Last updated on RxList: 5/4/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

GUAIFENESIN/PSEUDOEPHEDRINE SUSTAINED-RELEASE - ORAL

(gweye-FEN-eh-sin/sue-doh-eff-ED-rin)

USES: Guaifenesin/pseudoephedrine is used for the temporary relief of nose/sinus/ear congestion and cough with phlegm caused by the common cold, allergies, or infection. Pseudoephedrine is called a sympathomimetic and works by decreasing the swelling of nose and ear tissues and opening nose passages. Guaifenesin is called an expectorant. It works by making phlegm in the breathing tubes more liquid. This helps the cough to clear phlegm better.

Do not use this medication in children younger than 6 years unless specifically directed by the doctor. Some products are not recommended for use in children younger than 12 years. Consult with the doctor or pharmacist regarding your specific product. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (e.g., saline nose drops/spray, using a humidifier or infant nasal suction bulb).

HOW TO USE: Take this medication by mouth, usually every 12 hours with a full glass of water or as directed by your doctor. If stomach upset occurs, take with food or milk. Sustained-release products should be swallowed whole. Do not crush, chew, or split this medication. Doing so can destroy the long action of the drug and may increase side effects.

Dosage is based on your age, medical condition and response to therapy. If this medication does not require a prescription from your doctor, follow the specific dosing instructions on the packaging to find the correct dose for your age.

If your doctor directs you to take this medication daily, take it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

If your symptoms do not improve after 7 days, if they worsen, or if you develop a fever/chills, contact your doctor. Do not take more medication than is recommended.

SIDE EFFECTS: Mild stomach upset, trouble sleeping, dizziness, lightheadedness, headache, nervousness, fast heartbeat, loss of appetite, shaking, or unusual sweating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This product may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

If your doctor has directed you to use this medication, remember that 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: fast/irregular heartbeat, severe/uncontrolled shaking, difficulty urinating, decreased sexual ability.

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, mental/mood changes (e.g., anxiety, panic, hallucinations).

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, severe dizziness, trouble breathing.

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

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to pseudoephedrine or guaifenesin; or if you have any other allergies. Also tell your doctor if you have had a negative reaction to other sympathomimetics (e.g., ephedrine, phenylephrine).

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe high blood pressure, heart disease (e.g., severe coronary artery disease, angina, heart failure), certain types of fast heart rhythm problems (e.g., atrial fibrillation/flutter, paroxysmal supraventricular tachycardia-PSVT), a certain slow heart rhythm problem (sinus bradycardia), closed-angle glaucoma, difficulty urinating (e.g., due to enlarged prostate).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stroke, high blood pressure, chest pain (angina), heart attack, smoking, long-term breathing problems (e.g., asthma, chronic bronchitis, emphysema), cough with large amounts of phlegm, mental/mood disorders (e.g., anxiety, bipolar disorder, mania), epilepsy/seizure problems, certain blood vessel problems (e.g., Raynaud's disease, peripheral vascular disease), overactive thyroid (hyperthyroidism), low blood flow to the brain (cerebral insufficiency), diabetes, difficulty sleeping.

This drug may make you dizzy or lightheaded; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and lightheadedness.

Caution is advised when using this product in children because they may be more sensitive to its side effects, especially excitation, agitation, and increased blood pressure.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

The pseudoephedrine in this product passes into breast milk. It is not known whether guaifenesin passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

Avoid taking MAO inhibitors within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.

If you are currently using any of these medications, tell your doctor or pharmacist before starting this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other decongestants (taken by mouth or sprayed into the nose), products containing caffeine, some blood pressure medications (e.g., beta blockers, calcium channel blockers, reserpine, guanethidine, methyldopa, mecamylamine), tricyclic antidepressants (e.g., nortriptyline, amitriptyline), digoxin.

Pseudoephedrine may worsen the serious side effects of some medications used for migraine headaches (e.g., sumatriptan, naratriptan, zolmitriptan, ergotamine). Consult your pharmacist or doctor for more details.

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products before using them.

Pseudoephedrine and guaifenesin are available in both prescription and nonprescription products. Check the labels of all your medications carefully to make sure you are not taking more than one product containing these medications.

The guaifenesin in this product can affect the results of certain lab tests (e.g., uric acid levels, 5-hydroxyindoleacetic acid levels, vanillylmandelic acid levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness/fainting, severe weakness, fast irregular heartbeat, slow/shallow breathing, hallucinations, seizures, vomiting.

NOTES: Do not share this medication with others.

Drink plenty of fluids while taking this medication unless your doctor instructs you otherwise. This may help to relieve congestion. This medication is for temporary use only. Do not use for more than 7 days without first consulting your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.