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. Do not exceed recommended dosage.

General

Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus and prostatic hypertrophy and hyperreactivity to sympathomimetic amines. Antihistamines may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly.

Information for Patients

See PATIENT INFORMATION section.

Drug Interactions

See DRUG INTERACTIONS section.

Pregnancy Category C

Animal reproduction studies have not been conducted with these products. It is also not known whether these products can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to pregnant women only if clearly needed.

Nursing Mothers

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

Pediatric Use

Safety and effectiveness of Rondec Oral Drops in pediatric patients below the age of one month have not been established. Safety and effectiveness of Rondec Syrup in pediatric patients below the age of 18 months have not been established. Safety and effectiveness of Rondec Tablets in pediatric patients below the age of 6years have not been established. Safety and effectiveness of Rondec-TR Tablets in pediatric patients below the age of 12 years have not been established.

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