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Rx Only
DESCRIPTION
A Strawberry-Flavored, clear, alcohol-free, sugar-free, dye-free, liquid for oral administration.
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Each 5 mL (teaspoonful) contains:
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| Codeine phosphate |
7.5 mg |
| (WARNING: May be habit forming) |
| Phenylephrine hydrochloride |
7.5 mg |
| Diphenhydramine hydrochloride |
12.5 mg |
The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The chemical name is Morphinan-6-ol,7,8-didehydroxy-4,5-eposy-3methoxy-17-methyl-, (5α,6α)-, phosphate (1:1) (salt), hemihydrate.
Phenylephrine hydrochloride is a mydriatic and a decongestant and occurs as bitter crystals. The chemical name is: (-)-m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride.
Diphenhydramine hydrochloride is an antihistaminic. The chemical name is 2-(diphenylmethoxy)-N, N-dimethylethylamine hydrochloride.
Inactive Ingredients: Sodium benzoate, Citric acid, Saccharin sodium, Propylene glycol, Sorbitol, Flavor and Purified water.
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CLINICAL PHARMACOLOGY
Codeine Phosphate
Codeine is a narcotic analgesic and antitussive whose effects are due to central action. It is well absorbed via oral administration. Following absorption, codeine is metabolized primarily by enzymes in the liver into morphine and other metabolites. These are excreted primarily in the urine with negligible amounts in the feces.
Phenylephrine Hydrochloride
Phenylephrine is an alpha-adrenergic receptor agonist, and acts predominantly by a direct action on alpha (α) adrenergic receptors. It causes Constriction of blood vessels in the nasal mucosa, which may relieve nasal congestion, after oral ingestion. In therapeutic doses the drug causes little, if any, central nervous system stimulation, and has no significant stimulant effect on the beta (β) adrenergic receptors of the heart.
Diphenhydramine hydrochloride
is an ethanolamine antihistamine with anticholinergic (drying), anti-inflammatory and sedative effects. It does not prevent the release of histamine, but competitively antagonizes histamine at H1, histamine receptors and thus blocks it in the central nervous system and in the periphery. Its antihistaminic effects thus relieve and block such allergic reactions as increased capillary permeability and dilation, edema formation, "flare" and "itch" response, vasoconstriction and vasodilatation, and gastrointestinal and smooth-muscle constriction.
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