Rx Only

DESCRIPTION
Each 5 mL (one teaspoonful) for oral administration contains:

*
(WARNING-May be habit forming)
Dihydrocodeine Bitartrate* 3 mg
Brompheniramine Maleate 4 mg
Phenylephrine Hydrochloride 7.5 mg
(WARNING-May be habit forming)
Dihydrocodeine Bitartrate* 3 mg
Brompheniramine Maleate 4 mg
Phenylephrine Hydrochloride 7.5 mg

ENDACOF-DH Oral Liquid also contains: Sodium benzoate, Citric acid, Saccharin sodium, Propylene glycol, Sorbitol, Flavor and Purified water.

Dihydrocodeine Bitartrate is an antitussive with the chemical name (Morphinan-6-ol 4, 5α-Epoxy-3-methoxy-17-methylmorphinan-5α, 6α )=2,3=dihydroxybutanedioate (1:1) (salt) an odorless, fine white powder is an opioid analgesic. It has the following structural formula:

C18H23NO3•C4H6O6M. W. 451.47

Brompheniramine Maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine, γ-(4-bromophenyl)-N, N-dimethyl-, (±)-,(Z)-2-butenedicate (1:1), with the following structure:

C16H19BrN2-C4H4O4M. W. 435.31

Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically it is (-)-m-Hydroxy-α-[(methylamino) methyl]benzyl alcohol hydrochloride. Its chemical structure is as follows:

C9H13NO2-HClM. W. 203.67

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. Brompheniramine Maleate is an alkylamine type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect. 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.

INDICATIONS AND USAGE
ENDACOF-DH Oral 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 opiods 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 illeus. 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 caution sh