Hypotensive Effect
Dihydrocodeine, like all opioid analgesics, may cause hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or who receive concurrent therapy with drugs such as phenothiazines or other agents, which compromise vasomotor tone. Coldcough™ PD may produce orthostatic hypotension in ambulatory patients. This combination product should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Dependence
Dihydrocodeine can produce drug dependence of the codeine type and has the potential of being abused. This product should be prescribed and administered with the appropriate degree of caution. (See Drug Abuse and Dependence section).

PRECAUTIONS
General
This combination product should be used with caution in elderly or debilitated patients or those with any of the following conditions: adrenocortical insufficiency (e.g., Addison's disease); asthma; central nervous system depression or coma; chronic obstructive pulmonary disease; decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis); delirium tremens; diabetes; head injury; hypotension; hypertension; increased intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis. The benefits and risks of opioids in patients taking monoamine oxidase inhibitors and in those with a history of drug abuse should be carefully considered. This combination product may aggravate convulsions in patients with convulsive disorders, and, like all opioids, may induce or aggravate seizures in some clinical settings.

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

DRUG INTERACTIONS
General
Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids.

Other Central Nervous System Depressants
Patients receiving other opioid analgesics, sedatives or hypnotics, muscle relaxants, general anesthetics, centrally acting anti-emetics, phenothiazines or other tranquilizers, or alcohol concomitantly with this combination product may exhibit additive depressant effects on the central nervous system. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Concomitant use of hydrocodeine and antihistamines with alcohol and other CNS depressants may have an additive effect.

Monoamine Oxidase Inhibitors
Dihydrocodeine, like all opioids, interact with monoamine oxidase inhibitors causing central nervous system excitation and hypertension. MAO inhibitors and beta-adrenergic blockers increase the effects of sympathomimetics. They may also prolong and intensify the anticholinergic effects of antihistamines.

Information for Patient/Caregivers
Patients receiving Coldcough™ PD should be given the following information:

Patients should be advised that Coldcough™ PD may impair the mental or physical abilites required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Patients should be advised to report adverse experiences occurring during therapy.
Patients sh