Bentasil
FDA Label NDC 63104-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cloetta Italia S.r.l. for the product Bentasil (NDC 63104-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 5.8mg

Eucalyptus oil 5.7mg

Purpose

Cough Suppressant,

Oral Anesthetic

Uses

•for the temporary relief of minor sore throat

•for the temporary relief of coughs due to a cold

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

Ask A Doctor Before Use If You Have

•persistent or chronic cough such as occurs with smoking, asthma, or emphysema •cough accompanied by excessive phlegm (mucus)

When Using This Product

•do not exceed recommended dosage

Stop Use And Ask A Doctor If

•cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. •sore mouth does not improve in 7 days or irritation, pain or redness persists or worsens 

Directions

•adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed. 

•children under 5 years: ask a doctor

Other Information

• Phenylketonurics: Contains Phenylalanine (1.3) mg per drop. •3.2 calories per drop

Inactive Ingredients

•aspartame (contains phenylalanine), carnauba wax, citric acid, coconut and or palm kernel oil, flavor, gum arabic, maltitol, sorbitol, xylitol

Product Label

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