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).
There is currently no manufacturer warning information available for this drug.
POLY HIST DHC Liquid is indicated to control cough and provide for temporary relief from
congestion associated with the upper respiratory tract.
CIII
NDC 50991-521-16
Rx Only
DESCRIPTION:
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:
