General: Considerable caution should be exercised in patients with hypertension, diabetes
mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic
hypertrophy. The elderly (60 years and older) are more likely to exhibit adverse reactions.
Usage in Ambulatory Patients: Dihydrocodeine may impair the mental and/or physical abilities
required for the performance of potentially hazardous tasks such as driving a car or operating
machinery.
Respiratory Depression: Respiratory depression is the most dangerous acute reaction produced
by opioid agonist preparations, although it is rarely severe with usual doses. Opioids decrease the
respiratory tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory
depression occurs most frequently in elderly or debilitated patients, usually after large initial doses
in non-tolerant patients, or when opioids are given in conjunction with other agents that depress
respiration. This combination product should be used with caution in patients with significant chronic
obstructive pulmonary disease or cor pulmonale and in patients with a substantially decreased
respiratory reserve, hypoxia, hypercapnia, or respiratory depression.
Hypertensive 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
received concurrent therapy with drugs such as phenothiazine or other agents which compromise
vasomotor tone. This product may produce orthostatic hypotension in ambulatory patients. This
combination product should be administered with caution to patients with 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).
There is currently no manufacturer warning information available for this drug.
This product is indicated for the temporary relief of nasal congestion and dry, non-productive cough associated
with upper respiratory tract infections and allergies.
CIII
Description
Each 5 mL (one teaspoonful) for oral administration contains:
Dihydrocodeine Bitartrate ………………… 7.5 mg
(WARNING- May be habit forming)
Phenylephrine Hydrochloride………………. 7.5 mg
Guaifenesin……………………………………. 50 mg
This product contains the following inactive ingredients: Bitter Mask, FD and C Blue #1, FD and C Red #40,
Grape Flavor, Propylene Glycol, Purified Water, Sodium Saccharin, Sucrose.
This product contains ingredients of the following therapeutic classes: Antitussive, Decongestant and
Expectorant.
Dihydrocodeine Bitartrate is an antitussive with the chemical name (Morphinan-6-ol,4,5-epoxy-3-methoxy-
17-methyl-,(5α, 6α)-2,3-dihydroxybutanedioate (1:1) (salt). It has the following structural formula:
Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically it is Benzenemethanol,
3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-(-)-m-Hydroxy-α- [(methylamino)methyl]benzyl alcohol
hydrochloride. Its chemical structure is as follows:
Guaifenesin is an expectorant with the chemical name 1,2-Propanediol,3-(2-methoxyphenoxy)-, (±)-. It has the
following structural formula:
