Rondec® Syrup is a sugar-free, alcohol-free, bubblegum-flavored syrup for oral administration for adults and pediatric patients 2 years and older.

Each teaspoonful (5mL) contains:

Chlorpheniramine maleate . . . . . . . . . . . . . . . 4.0 mg
Phenylephrine hydrochloride . . . . . . . . . . . . 12.5 mg

Inactive ingredients: D&C Red No. 33, Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Saccharin, Sorbitol.

Chlorpheniramine maleate is an antihistamine with the chemical name: 2-Pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-,(Z)-2-butenedioate (1:1). Its chemical structure is as follows:

C₁₆H₁₉ClN₂ •C₄H₄O₄       M.W. 390.86

Phenylephrine hydrochloride is a mydriatic and a decongestant with the chemical name: (-)-m-Hydroxy-a-[(methylamino)methyl]benzyl alcohol hydrochloride. Its chemical structure is as follows:

C₉H₁₃NO₂•HCI     M.W. 203.67

Last updated on RxList: 4/9/2009

Symptomatic relief of seasonal and perennial allergic rhinitis and vasomotor rhinitis. Rondec® Syrup is an immediate dosage form allowing titration of dose 4-6 times per day.

Adults and Children 12 years of age and older: 1 teaspoonful (5mL) every 4 to 6 hours, not to exceed 6 teaspoonsful in 24 hours. Children 6 to under 12 years of age: 1/2 teaspoonful every 4 to 6 hours, not to exceed 3 teaspoonsful in 24 hours. Children 2 to under 6 years of age: 1/4 teaspoonful every 4 to 6 hours, not to exceed 1.5 teaspoonsful in 24 hours. Not recommended for use in children under 2 years of age.

In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.

Rondec® Syrup is a sugar-free, alcohol-free, bubble gum-flavored syrup available in bottles of 16 fluid ounces (473 mL), NDC 68188-061-16; bottles of 4 fluid ounces (118 mL), NDC 68188-061-04; and bottles of 20 mL, NDC 68188-061-20.

Storage Requirements

Store at Controlled Room Temperature between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Avoid exposure to heat. Keep tightly closed.

Dispense in USP tight, light-resistant container with child resistant closure.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Manufactured for: Alliant Pharmaceuticals, Inc., Alpharetta, GA 30022 USA. Rev. 09/05.

Last updated on RxList: 4/9/2009

Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and dysuria and, rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy. Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmia, respiratory difficulties, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, pallor and dysuria.

Antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol, and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa and mecamylamines. Effects of sympathomimetics are increased with MAO inhibitors and beta-adrenergic blockers.

Last updated on RxList: 4/9/2009

Do not exceed recommended dosage.

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure or prostatic hypertrophy. (See CONTRAINDICATIONS) Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur.

General

Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus and prostatic hypertrophy.

Use in Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Rondec® Syrup. It is not known whether this product can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether the drugs in Rondec® Syrup are excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious side effects in nursing infants, a decision should be made whether to discontinue nursing or discontinue the use of this product, taking into account the importance of the drug to the mother.

Last updated on RxList: 4/9/2009

No information is available as to specific results of an overdose of Rondec® Syrup. The signs, symptoms and treatment described below are those of H₁ antihistamine and ephedrine overdose.

Symptoms

Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, predominate symptoms are excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.

Should sympathomimetic symptoms predominate, central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmia, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea and abdominal cramps.

Treatment

(a) Evacuate stomach as condition warrants. Activated charcoal may be useful. (b) Maintain a nonstimulating environment. (c) Monitor cardiovascular status. (d) Do not give stimulants. (e) Reduce fever with cool sponging. (f) Use sedatives or anticonvulsants to control CNS excitation and convulsions. (g) Physostigmine may reverse anticholinergic symptoms. (h) Ammonium chloride may acidify the urine to increase urinary excretion of phenylephrine. (i) Further care is symptomatic and supportive.

Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines are contraindicated in patients with narrow angle glaucoma, urinary retention, peptic ulcer, and during an asthma attack.

Last updated on RxList: 4/9/2009

Antihistaminic and decongestant actions

Chlorpheniramine maleate possesses H₁ antihistaminic activity and mild anticholinergic and sedative effects. Peak plasma concentration is reached in 5 hours. Urinary excretion is the major route of elimination. The liver is assumed to be the major site of metabolic transformation.

Phenylephrine hydrochloride is an oral sympathomimetic amine that acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, phenylephrine has less pressor effect in normotensive adults. Serum half-life for phenylephrine is 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. About one-half of the administered dose is excreted in the urine.

Last updated on RxList: 4/9/2009

Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience moderate to severe drowsiness.Patients sensitive to sympathomimetic amines may notice mild CNS stimulation. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Patients should be warned accordingly.

Last updated on RxList: 4/9/2009

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.

ANTIHISTAMINES/DECONGESTANTS - ORAL

USES: This combination medication is used to temporarily treat runny/stuffy nose and other symptoms (e.g., ear congestion, watery/itchy eyes, itchy throat) caused by allergies, hay fever, the common cold, or other breathing illnesses (e.g., sinusitis). Decongestants help to relieve stuffy nose and ear congestion symptoms. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

Do not use this medication in children younger than 2 years unless directed by the doctor. 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: If you are taking the over-the-counter product, read all directions on the product package before taking this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, take it as directed.

Take this medication by mouth with or without food with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication may be taken with food or milk if stomach upset occurs.

If you are using the liquid form, use a medication measuring device to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose.

If you are using sustained-release tablets or capsules, swallow the medication whole. Do not crush, chew, or break the tablets or capsules. Doing so can destroy the long action of the drug and may increase side effects.

If you are using chewable tablets, chew each tablet thoroughly before swallowing.

If you are using a product made to dissolve in the mouth (tablets/strips), dry your hands before handling the medication. Place each dose on the tongue and allow to dissolve completely, then swallow it with saliva or with water.

Dosage is based on the product you are taking and your age, medical condition, and response to treatment. Do not increase your dose or take this medication more often than directed without your doctor's approval. Improper use (abuse) of this medication may result in serious harm (e.g., hallucinations, seizure, death).

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 worsen or do not improve after 7 days, if you also have fever/chills, or if you think you may have a serious medical problem, seek immediate medical attention.

SIDE EFFECTS: Drowsiness, dizziness, dry mouth/nose/throat/eyes, blurred vision, fast heartbeat, trouble sleeping, restlessness, irritability, headache, upset stomach, shaking, or constipation 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 prescribed 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, mental/mood changes (e.g., confusion, hallucinations), ringing in the ears, difficulty urinating, weakness.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizure.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of tongue/lips/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.

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 product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel problems (e.g., low blood flow to the brain/legs/hands), breathing problems (e.g., asthma, emphysema), diabetes, glaucoma, heart disease (e.g., angina, fast/irregular heartbeat, heart failure), high blood pressure, kidney problems, liver disease, seizure disorder, stomach/intestinal problems (e.g., ulcers, blockage), overactive thyroid (hyperthyroidism), trouble urinating (e.g., due to enlarged prostate, urinary retention).

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit alcoholic beverages while using this medication.

Liquid products, chewable tablets, or dissolving tablets/strips may contain sugar or aspartame. Liquid products may also contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

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

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

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

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

This medication may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: If you are taking this product under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist 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.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other antihistamines, blood pressure medications (especially reserpine, guanethidine, methyldopa, beta blockers such as atenolol, or calcium channel blockers such as nifedipine), other decongestants (taken by mouth or applied in the nose), digoxin, tricyclic antidepressants (e.g., amitriptyline, desipramine).

The decongestant in this product may worsen the serious side effects of some medications for migraine headaches (e.g., sumatriptan, naratriptan, zolmitriptan, ergotamine). If you are taking any of these migraine medications, tell your doctor before starting this decongestant product.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

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

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: irregular heartbeat, hallucinations, hot/dry skin, fainting, seizures.

NOTES: If your doctor has prescribed this medication, do not share it with others.

Keep all regular medical and laboratory appointments.

Do not take this product for several days before allergy testing because test results can be affected.

MISSED DOSE: If you are taking this product on a regular schedule and 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) or as directed on the package label, away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. 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.