Cepacol Sensations Cooling

Dosage form: lozenge
Ingredients: Benzocaine 4mg, Menthol 9mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-761

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® Sensations™
Cooling

Drug Facts

Active ingredient (in each lozenge)Purpose
Benzocaine 4 mgOral pain reliever
Menthol 9 mgOral pain reliever

Uses

temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

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
  • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

Do not use in a child under 5 years of age.

Stop use and ask a doctor or dentist if
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not exceed recommended dosage.

Directions
  • adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; 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 20-25°C (68-77°F)
  • protect contents from humidity

Inactive ingredients

FD&C blue #1, flavors, glucose, purified water, sodium bicarbonate, sorbitol, sucrose

Questions?

Call 1-888-963-3382 You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 4 Lozenge Carton

NDC 63824-761-04

new!

Cēpacol®
Sensations

COOLING

Benzocaine 4 mg, Menthol 9 mg – Oral Pain Reliever

Relieves Sore Throat Pain
Instant Cooling Comfort

4 Lozenges

ice cool

CEPACOL SENSATIONS   COOLING
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-761
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine4 mg
Menthol (Menthol) Menthol9 mg
Inactive Ingredients
Ingredient NameStrength
FD&C blue no. 1 
dextrose 
water 
sodium bicarbonate 
sorbitol 
sucrose 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize18mm
FlavorImprint CodeS
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-761-041 BLISTER PACK in 1 CARTON
14 LOZENGE in 1 BLISTER PACK
2NDC:63824-761-941 BLISTER PACK in 1 CARTON
24 LOZENGE in 1 BLISTER PACK
3NDC:63824-761-202 BLISTER PACK in 1 CARTON
310 LOZENGE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/10/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 07/2012
 
Reckitt Benckiser LLC

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.

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