CEPACOL SENSATIONS  COOLING- benzocaine and menthol lozenge 
Reckitt Benckiser LLC
Reference Label Set Id: 06f48907-8469-4f2f-a8f3-3fb3a89fcbc1

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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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

PRINCIPAL DISPLAY PANEL - 4 Lozenge Carton
CEPACOL SENSATIONS   COOLING
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-761
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine4 mg
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form9 mg
Inactive Ingredients
Ingredient NameStrength
FD&C blue no. 1 (UNII: H3R47K3TBD)  
dextrose (UNII: IY9XDZ35W2)  
water (UNII: 059QF0KO0R)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sorbitol (UNII: 506T60A25R)  
sucrose (UNII: C151H8M554)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize18mm
FlavorImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-761-041 in 1 CARTON
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-761-941 in 1 CARTON
24 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63824-761-202 in 1 CARTON
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/10/201208/31/2016
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 1/2016
Document Id: 7201aacf-f4f5-4e40-b9a5-c8e4152949df
Set id: f78eb9d3-ae6d-417e-9271-c5a9510c4e5d
Version: 4
Effective Time: 20160108
 
Reckitt Benckiser LLC