Benzonatate 100mg Capsule, USP contain 100 mg or 200 mg of benzonatate, USP.
Also, benzonatate Capsules also contain: D&C Yellow No. 10, gelatin, glycerin, methylparaben sodium and propylparaben sodium.
Therefore,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 or 200 mg capsule three times a day as needed for cough. Therefore, if necessary to control cough, up to 600 mg daily in three divided doses may be given. Also, Benzonatate should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
Benzonatate Capsules, USP are available as:
100 mg (oval, yellow) soft gelatin capsules with imprint “A5”.
NDC 62332-426-31 Bottles of 100
NDC 62332-426-71 Bottles of 500
200 mg (oblong, yellow) soft gelatin capsules with imprint “A6”.
NDC 62332-427-31 Bottles of 100
NDC 62332-427-71 Bottles of 500
Store at 20° to 25°C (68° to 77°F); excurs ions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Furthermore, dispense in tight, light-resistant container as defined in the USP.
Potential Adverse Reactions to benzonatate may include:
Firstly, Hypersens itivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.
GI: constipation, nausea, GI upset.
Dermatologic: pruritus; skin eruptions.
Also, deliberate or accidental overdose has resulted in death, particularly in children.
Usage In Pregnancy
Pregnancy Category C.
Firstly, animal reproduction studies is not done properly with benzonatate. It is also not clear whether benzonatate can cause fetal harm when a pregnant woman takes this drug or can affect reproduction capacity. In addition, a pregnant woman should take this drug only if it is necessary.
Also, It is not clear whether this drug is in human milk.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Also, carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate.
Firstly, safety and effectiveness in children below the age of 10 has not been established. To conclude, accidental ingestion resulting in death has been reported in children below age 10. Also, keep out of reach of children.