Poly-Tussin EX Syrup
Rx Only
CIII

DESCRIPTION
Each 5 mL (one teaspoonful) for oral administration contains:
Dihydrocodeine Bitartrate.................. 7.5 mg
(WARNING- May be habit forming)
Phenylephrine HCl............................. 5 mg
Guaifenesin..................................... 50 mg

This product contains the following inactive ingredients:
Purified Water, Propylene Glycol, Citric Acid, Sodium Citrate, Sodium Saccharin, Glycerin, Sorbitol,
Grape Flavor, Bitter Mask.

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)-. 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 HCl is a sympathomimetic, which acts predominately on alpha-receptors and has
little action on beta-receptors. It therefore functions as an oral nasal decongestant with minimal
CNS stimulation.

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.

Usage in Ambulatory Patients: Dihydrocodeine may im