Active Ingredient (Per Lozenge)
Phenol 29 mg
Cepastat
FDA Label NDC 63736-219
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals for the product Cepastat (NDC 63736-219). 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 (per lozenge), purpose, uses, directions, other information, inactive ingredients, questions?, principal display panel - 18 lozenges carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Anesthetic
Uses
temporarily relieves
- minor sore throat pain
- sore mouth
- minor mouth irritation
- pain associated with canker sores
Directions
- dissolve a lozenge slowly in mouth
| adults and children 12 years and older | take up to 2 lozenges every 2 hours as needed |
| children 6 to under 12 years | take up to 1 lozenge every 2 hours; not more than 10 lozenges in 24 hours |
| children under 6 years | ask a doctor |
Other Information
Store at room temperature, below 86°F (30°C). Protect contents from humidity.
Inactive Ingredients
Antifoam Emulsion, Caramel, Eucalyptus Oil, Gum Crystal, Menthol, and Sorbitol.
Questions?
Call 1-800-344-7239 or visit our website at www.insightpharma.com
Principal Display Panel - 18 Lozenges Carton
MENTHOL EUCALYPTUS FLAVOR
CĒPASTAT®
ORAL ANESTHETIC WITH PHENOL
FAST ACTING
SORE THROAT RELIEF
EXTRA STRENGTH*
18 LOZENGES
SUGAR FREE
Principle Display Panel (18 Lozenges carton)
* Please review the disclaimer below.
