Actives
Menthol 5mg in each Lozenge
Keptrils
FDA Label NDC 59240-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Magverz Inc for the product Keptrils (NDC 59240-004). 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 actives, inactives, purpose, uses, directions, warnings, keep out of reach of children, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactives
Honey, Citric Acid, Hyssop,Eucalyptus oil, Long pepper
Purpose
Oral Analgesic
Uses
Sore throat pain
Sore mouth
Minor mouth irritation
Directions
Adults and childrens 6 years older: allow lozene to dissolve slowly in the mouth; may be repeated every two hours as nedded or as directed by doctor or dentist .
Childrens under 6 years of age; do not use.
Warnings
Sore throat warninings : Server or persistent sore throat or sore throat accomapnied by high fever headache,nausea and vomittin may be serious. Consult a doctor promptly. Do not use for more than two days or gice to children under 6 years of age.
Keep Out Of Reach Of Children
Keep this and all drugs out of reach of children
Product Label
Keptril (Kep Honey)
* Please review the disclaimer below.
