Mintuss DR Syrup

Name: Mintuss DR Syrup

MINTUSS™ DR SYRUP

Rx Only

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician.

Hypertensive crisis can occur with concurrent use of phenylephrine and monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy), indomethacin or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued, and therapy to lower blood pressure should be instituted immediately. Fever should be managed by external cooling.

Antihistamines may produce drowsiness or excitation, particularly in children and elderly patients. Do no exceed recommended dosage. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Precautions

General

Because of its antihistamine component, Mintuss™ DR Syrup should be used with caution in patients with a history of bronchial asthma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Mintuss™ DR Syrup should be used judiciously and sparingly in patients with hypertension, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

Information for Patients

Antihistamines may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Patients should be cautioned accordingly.

Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA.)

Drug Interactions

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.) When such combined therapy is contemplated, the dose of one or both agents should be reduced. The use of phenylephrine with other sympathomimetic amines and MAO inhibitors (or for 14 days after stopping MAOI therapy) may produce an additive elevation of blood pressure. MAO inhibitors (or for 14 days after stopping MAOI therapy) may prolong the anticholinergic effects of antihistamines (See WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Mintuss™ DR Syrup to assess the carcinogenic and mutagenic potential, or the affect on fertility have not been performed.

Usage in Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Mintuss™ DR Syrup. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. It should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Mintuss ™ DR Syrup is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from this product, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in the pediatric population, under 6, have not been established.

For the Consumer

Applies to chlorpheniramine / dextromethorphan / phenylephrine: oral liquid, oral solution, oral syrup, oral tablet

What are some side effects that I need to call my doctor about right away?

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.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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