CEPACOL  EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge 
RB Health (US) 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®
Extra Strength Sore Throat cherry

Drug Facts

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

Uses

For the temporary relief of occasional

Warnings

Methemoglobinemia warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or 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, swelling, nausea, or vomiting, consult a doctor promptly.

Do not use

  • for teething
  • in children 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 out of 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 no. 33, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

1-866-682-4639
You may also report side effects to this phone number.

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

NDC 63824-713-16
READ ALL WARNINGS

Cēpacol®
EXTRA STRENGTH

#1
DOCTOR
RECOMMENDED

SORE THROAT
Benzocaine 15 mg • Menthol 3.6 mg | Oral Pain Relievers

16 Lozenges cherry
*based on amount of benzocaine per dose

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton
CEPACOL   EXTRA STRENGTH SORE THROAT CHERRY
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-713
Route of AdministrationORAL
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
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
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-713-162 in 1 CARTON07/15/2013
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-713-941 in 1 CARTON07/15/2013
24 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63824-713-041 in 1 CARTON07/15/2013
34 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 FINALpart35607/15/2013
Labeler - RB Health (US) LLC (081049410)

Revised: 5/2019
Document Id: b7cc8a99-499b-4dd4-86c8-0865bda9e181
Set id: 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0
Version: 5
Effective Time: 20190508
 
RB Health (US) LLC