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 affects of sympathomimetics.

Information for Patients:
Patients receiving this product should be given the following information:

This product may inhibit mental pr physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Report any adverse experiences occurring during therapy.
Do not adjust the dose of this product without consulting the prescribing professional.
Do not combine this product with alcohol or other central nervous system depressants.
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 this product 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 this product. 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 a pregnant woman 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 the 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 2-4 drops/kg q6h,
have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days,
with dosages decreased as tolerated.

Labor and Delivery:
This product is not recommended for use by women during and immediately before labor
and delivery because oral opioids may cause respiratory depression in the newborn.

Nursing Mothers:
Due to the possible passage of the ingredients into breast milk, this product should not
be given to nursing mothers.

Pediatric Use:
This product is not recommended for use in children under six years of age. Children under two years
may be more susceptible to respiratory arrest, coma, and death. Very young children may be more
susceptible to the effects, especially the vasopressor effects of sympathomimetic amines. Appropriate
studies on the relationship of age to the effects of guaifenesin have not been performed in the pediatric
population. However, no pediatric specific problems have been documented to date.

Geriatric Use:
This product should be given with caution to the elderly.

Hepatic Impairment: This product should be given with caution to patie