Benzonatate

The selected U.S. label indicates symptomatic relief of cough. It does not establish treatment of the underlying infection, asthma or other cause, a disease-specific pediatric regimen, or a preferred place in a guideline cough algorithm.

The dose section says children over 10 years; the pediatric section says safety/effectiveness below 10 are unestablished. These statements do not resolve dosing at exactly age 10; obtain exact-product pharmacist/prescriber review instead of inferring an age-10 regimen. The selected label supplies no renal/hepatic adjustment table, weight-based infant dose or automatic geriatric dose formula.

Hypersensitivity to benzonatate or related compounds. The precaution identifies para-aminobenzoic-acid-class anesthetic relatives such as procaine and tetracaine; do not convert this into a claim that every local anesthetic class is equivalent.

The selected label has no boxed warning. Its warnings still describe rapid fatal poisoning, severe hypersensitivity and the dangers of chewing capsules.

Potential reactions include sedation, headache, dizziness, confusion, hallucinations, nausea, constipation, GI upset, itching/rash and other sensory complaints. Severe allergy and deliberate/accidental fatal overdose have occurred. Overdose may produce restlessness, tremor, seizures, coma and cardiac arrest. Immediate emergency assessment and professional airway/cardiovascular support are essential; this page does not provide home gastric-emptying, charcoal or seizure-treatment instructions.

The selected label reports adverse CNS effects potentially related to prior sensitivity to related anesthetic agents or interaction with concomitant medicines; confusion/hallucinations have occurred with other prescriptions. It supplies no validated CYP-specific adjustment, exhaustive interaction list or quantified sedative-combination regimen. A medication review is needed rather than assuming no interactions.

Below 10 years safety/effectiveness are unestablished, and accidental ingestion has caused deaths. Preserve the over-10 wording of the dose section and seek review at exactly age 10. The label supplies no dedicated geriatric efficacy or dosing study; consider alertness, medication burden and ability to swallow an intact capsule.

No impairment-specific pharmacokinetic data or renal/hepatic dose-adjustment regimen is provided in the selected label. Individual assessment is required; an absence of a table does not establish safety in advanced disease.

Animal reproduction studies were not conducted; fetal harm and effects on reproductive capacity are unknown. Use in pregnancy only when clearly needed after individualized assessment. Human milk excretion is unknown, and the label advises caution during nursing. No contemporary pregnancy risk estimate, infant dose or breastfeeding safety guarantee is established.

Benzonatate anesthetizes stretch receptors in respiratory passages, lungs and pleura, reducing the cough reflex. At recommended doses the label reports no inhibition of the respiratory center; that statement does not apply to overdose or capsule-induced airway compromise.

Effect onset

Approximately 15–20 minutes.

Effect duration

Approximately 3–8 hours.

Data limits

The selected label supplies no routine plasma half-life, bioavailability percentage, metabolic pathway or renal-clearance estimate. These are not inferred from the duration of cough suppression.

Review the cause/course of cough, symptom response, hypersensitivity, sedation/confusion and ability to swallow whole capsules. Assess co-medications and pregnancy/nursing or significant organ disease individually. The selected label does not prescribe a routine laboratory panel or fixed monitoring interval.

Keep capsules securely out of children’s reach in their labeled container. Swallow intact, follow the 200 mg single/600 mg daily limits and skip rather than double a missed dose. Avoid oral intake if capsule-related mouth/throat numbness develops until it resolves; persistent/worsening numbness needs medical assessment. Any accidental ingestion or overdose needs immediate emergency attention; do not wait for a symptom or attempt home decontamination.

Ingredient / route

Benzonatate 100 mg · oral soft-gel capsule.

Appearance / imprint

Yellow soft gelatin capsule; 105.

Labeler / example NDC

Ascend Laboratories; manufactured by Softgel Healthcare · 67877-573-01, bottle of 100.

U.S. status

Prescription single-ingredient antitussive; selected SPL identifies an ANDA product, no DEA schedule.

100 mg

Yellow soft gel, 105; selected 100- and 500-count bottles.

150 mg

Yellow soft gel, 128; NDC 67877-574-01, 100-count bottle.

200 mg

Yellow soft gel, 106; NDC 67877-575-01, 100-count bottle (also 500-count).

Scope

Other labels/imprints may differ. No liquid, chewable capsule or dose obtained by cutting/opening these capsules is inferred.

Store selected capsules at 20–25°C and protect from light. Retain the labeled dispensed container, securely closed and inaccessible to children. Whole-capsule handling is a safety requirement, not an optional convenience.