CEPACOL  SORE THROAT- 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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Cēpacol®
Sore Throat

Drug Facts

Active ingredients (in each lozenge) Purposes
Benzocaine 15 mg Oral pain reliever
Menthol 3.6 mg Oral 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

D&C Red #33, FD&C Red #40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

Call 1-888-963-3382

You may also report side effects to this phone number.

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

Made in England

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

NDC 63824-712-16

NEW FORMULA!

Cēpacol®

SORE THROAT

Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Reliever

16 Lozenges
cherry

Principal Display Panel - 16 Lozenge Carton
CEPACOL   SORE THROAT
benzocaine and menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-712
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 15 mg
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 3.6 mg
Inactive Ingredients
Ingredient Name Strength
D&C red no. 33 (UNII: 9DBA0SBB0L)  
FD&C red no. 40 (UNII: WZB9127XOA)  
isomalt (UNII: S870P55O2W)  
maltitol (UNII: D65DG142WK)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color RED Score no score
Shape ROUND Size 18mm
Flavor CHERRY Imprint Code S
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-712-16 2 in 1 CARTON
1 8 in 1 BLISTER PACK
2 NDC:63824-712-98 72 in 1 CARTON
2 8 in 1 BLISTER PACK
3 NDC:63824-712-94 1 in 1 CARTON
3 4 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 03/15/2013
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 3/2013
Document Id: 2fb17506-fc19-4103-90d8-a9bf0d890645
Set id: 7377f536-5196-4c78-a94c-16e43d899b97
Version: 2
Effective Time: 20130322
 
Reckitt Benckiser LLC