FDA Label for Cepastat Extra Strength

View Indications, Usage & Precautions

Cepastat Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (Per Lozenge)



Phenol 29 mg


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 oldertake up to 2 lozenges every 2 hours as needed
    children 6 to under 12 yearstake up to 1 lozenge every 2 hours; not more than 10 lozenges in 24 hours
    children under 6 yearsask 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


* Please review the disclaimer below.