Product Description.:
133
capsule , clear , yellow , oval oblong
White ink
Each softgel (soft gelatin capsule), for oral administration, contains 100 mg benzonatate. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, methylparaben, propylparaben and purified water.
INDICATIONS
Benzonatate is indicated for the symptomatic relief of cough.
DOSAGE AND ADMINISTRATION
Adults and children over 10 years of age: Usual dose is one 100 mg softgel t.i.d. as required. If necessary, up to 6 softgels daily may be given.
HOW SUPPLIED
Each yellow softgel contains 100 mg of benzonatate and is available in bottles of 100's and 500's.
The softgels should be protected from light, moisture and humidity, and stored at controlled room temperature 15?-30?C (59?-86?F). Dispense in a tight, light-resistant container as defined in USP/NF.
WARNINGS
Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the softgel instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate in combination with other prescribed drugs.
PRECAUTIONS
Benzonatate is chemically related to anesthetic agents of the para-aminobenzoic acid class (e.g., procaine tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.