CEPACOL  EXTRA STRENGTH SORE THROAT HONEY LEMON- benzocaine and menthol lozenge 
Atlantic Biologicals Corps

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 honey lemon

Drug Facts

Active ingredients (in each lozenge)Purposes
Benzocaine 15 mgOral pain reliever
Menthol 2.6 mgOral pain reliever

Uses

Temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Warnings

METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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 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.

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 of age and older: allow one 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 between 20-25°C (68-77°F)
  • protect contents from humidity

Inactive ingredients

D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

Call 1-866-682-4639

You may also report side effects to this phone number.

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

CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE

Label Image
CEPACOL   EXTRA STRENGTH SORE THROAT HONEY LEMON
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0732(NDC:63824-732)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 mg
Inactive Ingredients
Ingredient NameStrength
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
isomalt (UNII: S870P55O2W)  
maltitol (UNII: D65DG142WK)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize18mm
FlavorHONEY (Honey-Lemon) Imprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0732-150 in 1 BOX09/17/2019
11 in 1 POUCH; 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 - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL(17856-0732) , REPACK(17856-0732)

Revised: 9/2019
Document Id: 55067800-bf62-41cb-b89f-762411d225c6
Set id: 08160ced-e19b-443e-ab16-0d3e4ae8a8ab
Version: 3
Effective Time: 20190917
 
Atlantic Biologicals Corps