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

This product may inhibit mental or 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 effect 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 q4h, 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 of 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 patients with hepatic insufficiency.
Since dihydrocodeine is metabolized by the li