Medication Guide App

Cepacol Fizzlers

Dosage form: tablet, orally disintegrating
Ingredients: BENZOCAINE 6mg
Labeler: Combe Incorporated
NDC Code: 11509-0025

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Cepacol Fizzlers

Cēpacol® Fizzlers

Active Ingredients (in each lozenge)

Benzocaine 6.0 mg                              

Purpose

Oral anesthetic

Uses

temporarily relieves occasional minor sore throat pain

Warnings

Allergy alert  

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other ‘caine’ anesthetics.

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea or vomiting may be serious.  Consult a doctor promptly.  Do not use for more than 2 days or give to children under 5 years of age.

Stop use and ask a doctor if

symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.

If pregnant or breast feeding

ask a health professional before use.

Keep this and all drugs out of reach of children  

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not exceed recommended dosage

Directions
  • children 5 years of age and older: place tablet on tongue and let dissolve. For best results, do not chew; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: do not use.

Other information   
  • store at room temperature (68-77°F) (20-25°C)  
  • protect contents from humidity

Inactive ingredients  

citric acid, colloidal silicon dioxide, crospovidone, D&C red no.27, FD&C blue no. 1, flavor (corn syrup solids, modified corn starch, natural flavors), magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sucralose

Principal Display Panel

Childrens

Cēpacol

Fizzlers®

Just for Sore throats

Relieces Pain

Fast

Instantly dissolves

on the tongue

12 Grape Flavor Tablets

CEPACOL FIZZLERS 
benzocaine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0025
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE6 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID 
COLLOIDAL SILICON DIOXIDE 
CROSPOVIDONE 
D&C RED NO. 27 
D&C BLUE NO. 1 
MAGNESIUM STEARATE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
SODIUM BICARBONATE 
SUCRALOSE 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize9mm
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0025-12 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
16 TABLET, ORALLY DISINTEGRATING (6 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/01/2009
Labeler - Combe Incorporated (002406502)
Establishment
NameAddressID/FEIOperations
CIMA Labs Inc.173625823MANUFACTURE

Revised: 12/2009
 
Combe Incorporated

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)