Tosfedrin FG

Phenylephrine HCl w/guaifenesin long acting tablets are indicated for the symptomatic relief of sinusitis, bronchitis, pharyngitis, and coryza when these conditions are associated with nasal congestion and viscous mucus in the lower respiratory tract.

Adults and children 12 years of age and older: one tablet twice daily (every 12 hours).

Children 6 to under 12 years: one-half (1/2) tablet twice daily (every 12 hours). Phenylpropanolamine HCl w/guaifenesin long acting tablets are not recommended for children under 6 years of age.

Tablets may be broken in half for ease of administration without affecting release of medication but should not be crushed or chewed prior to swallowing.

Phenylephrine HCl w/guaifenesin long acting tablets are contraindicated in individuals with known hypersensitivity to sympathomimetics, severe hypertension, ventricular tachycardia, or in patients receiving monoamine oxidase inhibitors.

WARNINGS

Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy.

PRECAUTIONS

Information for the Patient: Do not crush or chew phenylephrine HCl w/ guaifenesin long acting tablets prior to swallowing.

Drug/Laboratory Test Interactions: Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindole-acetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA).

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with phenylephrine HCl w/guaifenesin long acting tablets. It is also not known whether phenylephrine HCl w/guaifenesin long acting tablets, can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine HCl w/guaifenesin long acting tablets, should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether the drugs in phenylephrine HCl w/guaifenesin long acting tablets, are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the product, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of phenylephrine HCl w/guaifenesin long acting tablets, in children below the age of 6 have not been established.

Possible adverse reactions include nervousness, insomnia, restlessness, headache, nausea, or gastric irritation. These reactions seldom, if ever, require discontinuation of therapy. Urinary retention may occur in patients with prostatic hypertrophy.

Side effects may include:
Anxiety, convulsions, depression, difficulty breathing, difficulty urinating (in men with an enlarged prostate), hallucinations, headache, inability to sleep or difficulty sleeping, increased heart beat, irritability, irritated stomach, nausea, nervousness, paleness, palpitations, restlessness, tremor, weakness, vomiting

The treatment of overdosage should provide symptomatic and supportive care. If the amount ingested is considered dangerous or excessive, induce vomiting with ipecac syrup unless the patient is convulsing, comatose, or has lost the gag reflex, in which case perform gastric lavage using a large-bore tube. If indicated, follow with activated charcoal and a saline cathartic. Since the effects of phenylephrine HCl w/guaifenesin long acting tablet may last up to 12 hours, treatment should be continued for at least that length of time.