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. Information for Patient/ Caregivers Patients receiving Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be given the following information: 1. Patients should be advised that Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.2. Patients should be advised to report adverse experiences occurring during therapy.3. Patients should be advised not to adjust the dose of Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid without consulting the prescribing professional.4. Patients should not combine Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid with alcohol or other central nervous system stimulants.5. Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of opioids and other drug use during pregnancy on themselves and their unborn child. Patients should be advised that Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid. It is also not known whether this combination product can cause fetal harm when administered to pregnant women or can affect reproduction capacity in males and females. This combination product should be given to pregnant women only if clearly needed, especially during the first trimester. Nonteratogenic Effects Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7-1.0 mg/kg q6h, phenobarbital 2 mg/kg q6h, and paregoric 24 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of ther