Rx ONLY

DESCRIPTION
This product contains ingredients in the following therapeutic classes: Antitussive, Decongestant and Antihistamine.

Coldcough™ PD is sugar free and alcohol free.

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

*
(WARNING-May be habit forming)
Dihydrocodeine Bitartrate* 3.0 mg
Chlorpheniramine Maleate 2.0 mg
Phenylephrine Hydrochloride 7.5 mg

Inactive Ingredients: Sodium benzoate, Citric acid, Sodium saccharin, Sorbitol, Propylene glycol, D&C Red No. 33, FD&C Blue No. 1, Grape flavor, Purified water.

Dihydrocodeine Bitartrate is a semi-synthetic narcotic/analgesic, its structure is as follows:

C18H23NO3 • C4H6O6M.W. 451.47

Morphinan-6-ol, 4,5-epoxy-3-methoxy-17-methyl-,(5α,6α)-2,3-dihydroxybutanedioate (1:1) (salt).

Chlorpheniramine Maleate is an antihistaminic, its structure is as follows:

C16H19ClN2 • C4H4O4M.W. 390.86

2-Pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1).

Phenylephrine Hydrochloride is an orally effective nasal decongestant, its structure is as follows:

C9H13NO2 • HClM.W. 203.67

Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-,hydrochloride (R)-.

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. Chlorpheniramine 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
Coldcough™ PD 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 (and for 14 days after stopping MAOI therapy). 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
Do not exceed r