Phenylephrine and Guaifenesin Drops

Generic name: phenylephrine hydrochloride and guaifenesin
Dosage form: liquid
Drug class:Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION:

Each dropperful (1.0 mL) contains:
Phenylephrine Hydrochloride ..... 1.5 mg
Guaifenesin ..... 20 mg

Inactive Ingredients: Citric Acid, Sodium Citrate, Sodium Saccharin, Sorbitol, Glycerin, Propylene Glycol, Raspberry Flavor, FD&C Red#40, Purified Water, Methylparaben and Propylparaben.

Phenylephrine HCl is a decongestant having the chemical name Benzenemethanol, 3-hydroxy-α-[(methylamino) methyl]-,hydrochloride(R)-

Guaifenesin is an expectorant having the chemical name, 1,2-propanediol, 3-(2 methoxyphenoxy)-

CLINICAL PHARMACOLOGY:

Phenylephrine HCl is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors. Therefore it functions as an oral nasal decongestant with minimal CNS stimulation. Guaifenesin is an expectorant which exerts its action by stimulation of reflexes from the stomach, and acts through the nauseant effect which increases the output from the secretory glands of the respiratory tract.

INDICATIONS AND USAGE:

RE Phenylephrine 1.5 mg/Guaifenesin 20 mg Drops is especially formulated for pediatric patients to provide symptomatic relief during upper respiratory infections. It provides an expectorant action and liquefaction of the bronchial mucus. It is not a substitute for treatment with antibiotics or chemotherapeutic agents, when these are indicated.

CONTRAINDICATIONS:

RE Phenylephrine 1.5 mg/Guaifenesin 20 mg Drops is contraindicated in persons with hypersensitivity to any of the ingredients, severe hypertension or coronary artery disease, as well as patients taking MAO inhibitors.

WARNINGS:

Sympathomimetic amines should be used withcaution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with