CEPACOL SENSATIONS  COOLING - benzocaine and menthol lozenge 
Reckitt Benckiser LLC

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.

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Drug Facts

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

Uses

temporary relief of occasional

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

Other information

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 - 20 Lozenges Carton

NDC 63824-761-20

1 LOZENGE EVERY 2
hours

new!

Cēpacol®
Sensations™

COOLING

Benzocaine 4 mg, Menthol 9 mg – Oral Pain Reliever

Relieves Sore Throat Pain
Instant Cooling Comfort

20 Lozenges
ice cool

PRINCIPAL DISPLAY PANEL - 20 Lozenges Carton

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) Menthol4 mg
Inactive Ingredients
Ingredient NameStrength
FD&C blue no. 1 
dextrose 
water 
sodium bicarbonate 
sorbitol 
sucrose 
Product Characteristics
ColorBLUEScore no score
ShapeROUNDSize27mm
FlavorImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63824-761-2020 LOZENGE in 1 BLISTER PACKNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/01/201207/02/2012

Labeler - Reckitt Benckiser LLC (094405024)

Revised: 07/2012 Reckitt Benckiser LLC