WARNINGS
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.
A persistent cough may be a sign of a serious condition. If cough persists for more than one week or tends to recur, or is
accompanied by fever, rash, or persistent headache, patient re-evaluation should be considered.
PRECAUTIONS
General: There are studies which demonstrate that carbetapentane has antitussive activity which may suppress or modify
cough. Before prescribing medication to suppress or modify cough, identify and provide therapy for the underlying cause of
the cough and take caution that modification of cough does not increase the risk of clinical or physiologic complications.
Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure,
diabetes mellitus, and prostatic hypertrophy.
Pregnancy Category C:
Animal reproduction studies have not been conducted with this product. It is not known whether this product can cause fetal
harm when administered to a pregnant woman or affect reproductive capacity. Give to pregnant women only if clearly needed.
Nursing Mothers:
It is not known if the drugs in this product are excreted in human milk. Since many drugs may be excreted into human milk
and because of the potential for serious side effects in the nursing infant, this product should only be given to nursing mothers
if clearly needed.
Pediatric use:
Safety and effectiveness in pediatric patients below the age of six have not been established. Product not intended for
administration for children 6 years of age and under.
Geriatric use:
The elderly (60 years and older) are more likely to have adverse reactions to sympathomimetics. Overdosage of
sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death.
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