Poly-Tussin EX Syrup

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.

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.

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).

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.

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

Poly-Tussin EX is supplied as a clear colorless, alcohol free, gluten free, sugar free,
dye free syrup with a grape flavor in 16 fl oz (473 mL) bottles, NDC 50991-529-16,
and 15 mL professional sample (NDC 50991-529-15)

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONALASSISTANCE
OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Store at controlled room temperature, 15o-30oC (59o-86oF).


(On 16 fl oz Bottle:)
Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
This bottle is not to be dispensed to consumer.

(On 15 mL Bottle:)
Supplied in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Rx only

Distributed for:
Poly Pharmaceuticals
Mobile, AL 36619