Deconsal CT (Phenylephrine HCl and Pyrilamine Maleate Tannate Chewable Tablets)
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Deconsal CT (Phenylephrine HCl and Pyrilamine Maleate Tannate Chewable Tablets)

Deconsal® CT
(phenylephrine hcl and pyrilamine maleate) Tannate Chewable Tablets

DRUG DESCRIPTION

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets are an antihistamine/nasal decongestant combination for oral administration as a chewable tablet.

Each Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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

Inactive ingredients: Calcium phosphate dibasic, compressible sugar, corn starch, grape flavor, hypromellose, magnesium aluminum silicate, magnesium stearate, microcrystalline cellulose, saccharin sodium, talc, tannic acid, and xanthan gum.

See DOSAGE AND ADMINISTRATION section for further descriptive composition.

What are the possible side effects of this drug?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • severe dizziness, anxiety, restless feeling, or nervousness, confusion, hallucinations, unusual thoughts or behavior;
  • easy bruising or bleeding, fever, chills, body aches, flu symptoms;
  • urinating less than usual or not at all; or
  • nausea, stomach pain,...

Read All Potential Side Effects and See Pictures of Deconsal CT »

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets are indicated for the symptomatic relief of the coryza and nasal congestion associated with the common cold, sinusitis, allergic rhinitis and other upper respiratory tract infections. Appropriate therapy should be provided for the primary disease.

DOSAGE AND ADMINISTRATION

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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.

HOW SUPPLIED

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets are available as grape-flavored, dye-free, mottled brown-colored, round, scored tablet imprinted with CC on one side and the score line on the other

NDC No.: 10122-202-10 - Bottles of 100 Chewable Tablets and NDC No.: 10122-202-02 single tablet sample pouches.

Store at controlled room temperature, 20o-25o C (68o -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 reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The most common effects associated with antihistamines have been drowsiness sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics 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.

Read the Deconsal CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

MAO inhibitors may prolong and intensify the anticholinergic effects of sympathomimetic agents. Thus, concomitant administration of Deconsal® CT Tannate Chewable Tablets and MAO inhibitors should be avoided (see "CONTRAINDICATIONS").

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

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.

PRECAUTIONS

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.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term animal studies have been performed with Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets.

Pregnancy

Teratogenic Effects- Pregnancy Category C

Animal reproduction studies have not been conducted with Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets. It is also not known whether Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Tablets should not be administered to a nursing mother.

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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.

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.

CONTRAINDICATIONS

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see "PRECAUTIONS-DRUG INTERACTIONS").

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic effect of pyrilamine.

Phenylephrine

Phenylephrine is a decongestant which is a potent postsynaptic 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.

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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 reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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 reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Deconsal® CT
(phenylephrine hcl and pyrilamine maleate) Tannate Chewable Tablets

DRUG DESCRIPTION

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets are an antihistamine/nasal decongestant combination for oral administration as a chewable tablet.

Each Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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

Inactive ingredients: Calcium phosphate dibasic, compressible sugar, corn starch, grape flavor, hypromellose, magnesium aluminum silicate, magnesium stearate, microcrystalline cellulose, saccharin sodium, talc, tannic acid, and xanthan gum.

See DOSAGE AND ADMINISTRATION section for further descriptive composition.

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Deconsal® CT
(phenylephrine hcl and pyrilamine maleate) Tannate Chewable Tablets

DRUG DESCRIPTION

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets are an antihistamine/nasal decongestant combination for oral administration as a chewable tablet.

Each Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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

Inactive ingredients: Calcium phosphate dibasic, compressible sugar, corn starch, grape flavor, hypromellose, magnesium aluminum silicate, magnesium stearate, microcrystalline cellulose, saccharin sodium, talc, tannic acid, and xanthan gum.

See DOSAGE AND ADMINISTRATION section for further descriptive composition.

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Deconsal® CT
(phenylephrine hcl and pyrilamine maleate) Tannate Chewable Tablets

DRUG DESCRIPTION

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets are an antihistamine/nasal decongestant combination for oral administration as a chewable tablet.

Each Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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

Inactive ingredients: Calcium phosphate dibasic, compressible sugar, corn starch, grape flavor, hypromellose, magnesium aluminum silicate, magnesium stearate, microcrystalline cellulose, saccharin sodium, talc, tannic acid, and xanthan gum.

See DOSAGE AND ADMINISTRATION section for further descriptive composition.

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Deconsal CT Patient Information Including Side Effects

Brand Names: Aldex D, Deconsal CT Tannate, K-Tan, Pyril Tann-12, Pyrlex PD, Ryna-12, Ryna-12S, Rynesa 12S, Ry-T-12, Viravan-S, Viravan-T, V-Tann

Generic Name: phenylephrine and pyrilamine (Pronunciation: FEN il EFF rin and pir IL a meen)

What is this drug (Deconsal CT)?

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of phenylephrine and pyrilamine is used to treat runny or stuffy nose, sneezing, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Phenylephrine and pyrilamine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of this drug?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • severe dizziness, anxiety, restless feeling, or nervousness, confusion, hallucinations, unusual thoughts or behavior;
  • easy bruising or bleeding, fever, chills, body aches, flu symptoms;
  • urinating less than usual or not at all; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • nausea, stomach pain, constipation, mild loss of appetite;
  • dry mouth;
  • warmth, tingling, or redness under your skin;
  • blurred vision;
  • dizziness, drowsiness;
  • problems with memory or concentration;
  • restless or excitability (especially in children);
  • sleep problems (insomnia); or
  • skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Deconsal CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about this drug?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine.

Side Effects Centers

Deconsal CT Patient Information including How Should I Take

What should I discuss with my health care provider before taking this drug?

Do not use this medication if you are allergic to phenylephrine or pyrilamine, or to other antihistamines, decongestants, diet pills, stimulants, or ADHD medications.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking phenylephrine and pyrilamine, tell your doctor if you are allergic to any drugs, or if you have:

  • heart disease or high blood pressure;
  • diabetes;
  • a thyroid disorder;
  • glaucoma;
  • kidney disease;
  • an enlarged prostate; or
  • problems with urination.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take this drug?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

Side Effects Centers

Deconsal CT Patient Information including If I Miss a Dose

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking this drug?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pyrilamine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

What other drugs will affect this drug?

Before taking phenylephrine and pyrilamine, tell your doctor if you are also taking:

  • a diuretic (water pill);
  • salicylates such as aspirin, Novasal, Doan's Extra Strength, Salflex, Tricosal, and others;
  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;
  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
  • bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with phenylephrine and pyrilamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about phenylephrine and pyrilamine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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