Rx Only
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:

CLINICAL PHARMACOLOGY
Dihydrocodeine is a semisynthetic narcotic analgesic/antitussive related to codeine, with multiple actions
qualitatively similar to those of codeine: the most prominent of these involve the central nervous system
and organs with smooth muscle components.

Phenylephrine hydrochloride affects its vasoconstrictor activity by releasing noradrenaline from sympathetic
nerve endings, and from direct stimulation of α-adrenoreceptos in blood vessels.

Guaifenesin is an expectorant, which increases respiratory tract fluid secretions and helps to loosen phlegm
and bronchial secretions. By reducing the viscosity of secretions, guaifenesin increases the efficiency of the
cough reflex and of ciliary action in removing accumulated secretions from the trachea and bronchi.

INDICATIONS AND USAGE
This product is indicated for the temporary relief of nasal congestion and dry, non-productive cough associated
with upper respiratory tract infections and allergies.

CONTRAINDICATIONS
This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine,
or any of the active or inactive components listed above, or in any situation where opioids are contraindicated
including significant respiratory depression (in unmonitored settings or in the absence of resuscitation
equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus. Sympathomimetic agents
are contraindicated in patients with severe hypertension, severe coronary artery disease, patients with narrow
angle glaucoma, bronchial asthma, urinary retention, peptic ulcer, and during an asthmatic attack. This product
is contraindicated in women who are pregnant.

WARNINGS
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.