POLY HIST DHC Liquid
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:

CLINICAL PHARMACOLOGY
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
stimulation.

Pyrilamine Maleate is an antihistamine used in suppressing symptoms of allergic rhinitis. However, it
is more prone to cause drowsiness than some other antihistamines.

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.

CONTRAINDICATIONS
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.

WARNINGS
General: Considerable cautio