POLY HIST DHC- dihydrocodeine bitartrate, phenylephrine hydrochloride and pyrilamine maleate liquid
Poly Pharmaceuticals, Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Each 5 mL (one teaspoonful) for oral administration contains:
Dihydrocodeine Bitartrate*…………………….. 7.5 mg
(*WARNING — May be habit forming)
Phenylephrine HCl……………………………… 5 mg
Pyrilamine Maleate…………………………….. 7.5 mg
POLY HIST DHC Liquid also contains: Citric Acid, Glycerin, Fruit Gum Flavor, Propylene Glycol,
Sorbitol, Purified Water, Sodium Citrate, Sodium Saccharin.
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) 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6α-ol (+)-tartrate (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:
Pyrilamine Maleate is an antihistamine having the chemical name 1,2-Ethanediamine, N-[(4-methoxyphenyl)methyl]-N’,
N’-dimethyl-N-2-pyridinyl-, (Z)-2-butenedioate (1:1) 2-[[2-Dimethylamino)ethyl](p -methoxybenzyl)amino] pyridine
maleate (1:1); Its structural formula is as follows:
Dihydrocodeine Bitartrate Chemical StructurePhenylephrine Hydrochloride Chemical StructurePyrilamine Maleate Chemical Structure
Dihydrocodeine is a semi-synthetic narcotic analgesic 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
Pyrilamine Maleate is an antihistamine used in suppressing symptoms of allergic rhinitis. However, it
is more prone to cause drowsiness than some other antihistamines.
POLY HIST DHC Indications and Usage
POLY HIST DHC Liquid is indicated to control cough and provide for temporary relief from
congestion associated with the upper respiratory tract.
This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine,
codeine, or any of the active and 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. Antihistamines and sympathomimetics are contraindicated in patients receiving
antihypertensive or antidepressant drugs containing monoamine oxidase (MAO) inhibitors.
Antihistamines should not be used to treat lower respiratory tract symptoms or be given to
premature or newborn infants. 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 asthma 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. Antihistamines may
cause excitability, especially in children. At dosages higher than the recommended dose, nervousness,
dizziness, or sleeplessness may occur.
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 rate, tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory
depression occurs most frequently in elderly more 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.
Hypotensive 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
receive concurrent therapy with drugs such as phenothiazines or other agents which compromise
vasomotor tone. POLY HIST DHC Liquid may produce orthostatic hypotension in ambulatory patients.
This combination product should be administered with caution to patients in 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).
General: This combination product should be used with caution in elderly or debilitated patients
or those with any of the following conditions: adrenocortical insufficiency (e.g., Addison’s disease);
asthma; central nervous system depression or coma; chronic obstructive pulmonary disease;
decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or
kyphoscoliosis); delirium tremens; diabetes; head injury; hypotension; hypertension; increased
intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and
toxic psychosis. The benefits and risks of opioids in patients taking monoamine oxidase inhibitors
and in those with a history of drug abuse should be carefully considered. This combination product
may aggravate convulsions in patients with convulsive disorders, and like all opioids, may induce or
aggravate seizures in some clinical settings.
General: Sympathomimetics may reduce the antihypertensive effects of methyldopa,
mecamylamine, reserpine and veratrum alkaloids.
Other Central Nervous System Depressants: Patients receiving other opioid analgesics,
sedatives or hypnotics, muscle relaxants, general anesthetics, centrally acting anti-emetics,
phenothiazines or other tranquilizers, or alcohol concomitantly with this combination product
may exhibit additive depressant effects on the central nervous system. When such combined
therapy is contemplated, the dose of one or both agents should be reduced. Concomitant use
of dihydrocodeine and antihistamines with alcohol and other CNS depressants may have an
Monoamine Oxidase Inhibitors: Dihydrocodeine, like all opioids, interact with monoamine
oxidase inhibitors causing central nervous system excitation and hypertension. MAO inhibitors
and beta-adrenergic blockers increase the effects of sympathomimetics. They may also prolong
and intensify the anticholinergic effects of antihistamines.
Patients receiving POLY HIST DHC Liquid should be given the following information:
1. Patients should be advised that POLY HIST DHC Liquid may impair the mental or
physical abilities required for the performance of potentially hazardous tasks such
as driving a car or operating machinery.
2. Patients should be advised to report adverse experiences occurring during therapy.
3. Patients should be advised not to adjust the dose of POLY HIST DHC Liquid without
consulting the prescribing professional.
4. Patients should not combine POLY HIST DHC Liquid with alcohol or other central
nervous system stimulants.
5. 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 POLY HIST DHC Liquid is a potential drug of abuse. They
should protect if from theft, and it should never be given to anyone other than the individual
for whom it was prescribed.
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