No information available.

Administer with care in patients with cardiac or peripheral vascular diseases or hypertension. Until the patients response has been determined, he should be cautioned against engaging in operations which require alertness, such as driving an automobile, operating machinery, etc. Patients receiving antihistamines should be warned against possible additive effects with CNS depressants such as alcohol, hypnotics, sedatives, tranquilizers, etc. Since hydrocodone may produce drowsiness, persons who perform hazardous tasks requiring mental alertness or physical coordination should be cautioned accordingly.

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with Histinex^® HC Syrup.

Teratogenic Effects. Pregnancy category C.

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

It is not known whether this drug 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 Histinex^® HC Syrup, a decision should be made whether to discontinue nursing or discontinue the drug, taking into the account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients below the age of 6 has not been established.

Clinical studies of Histinex^® HC syrup did not include sufficient numbers of subjects aged 65 and over to determine whetherthey respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Histinex^® HC syrup and observed closely.

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