CEPACOL  SORE THROAT- benzocaine and menthol, unspecified form lozenge 
Reckitt Benckiser LLC
Reference Label Set Id: 3b47cf40-e6ef-489a-9394-27e32a4f71c9

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®
Sore Throat

Drug Facts

Active ingredients (in each lozenge)Purpose
Benzocaine 15 mgOral pain reliever
Menthol 3.6 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

acesulfame potassium, D&C red #33, FD&C red #40, flavors, glucose, propylene glycol, purified water, sodium bicarbonate, sucrose

Questions or Comments?

Call 1-888-963-3382

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

PRINCIPAL DISPLAY PANEL - 4 Lozenge Carton

NDC 63824-711-94
SAMPLE – NOT TO BE SOLD

Cēpacol®

SORE THROAT

Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Reliever

  • Instant Acting
  • Maximum
    Strength
    Numbing

4 Lozenges
cherry

PRINCIPAL DISPLAY PANEL - 4 Lozenge Carton
CEPACOL   SORE THROAT
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-711
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine15 mg
Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A) Menthol, unspecified form3.6 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium (UNII: 23OV73Q5G9)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
FD&C red no. 40 (UNII: WZB9127XOA)  
dextrose (UNII: IY9XDZ35W2)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sucrose (UNII: C151H8M554)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-711-162 in 1 CARTON
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-711-941 in 1 CARTON
24 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63824-711-9872 in 1 CARTON
38 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 FINALpart35605/28/201204/30/2013
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 4/2015
Document Id: a316010e-e242-46e3-b5d0-e56e0e63c80b
Set id: 78bc8273-4daf-4be9-8686-7d2537382031
Version: 3
Effective Time: 20150414
 
Reckitt Benckiser LLC