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Cepacol Extra Strength Sore Throat sugar free cherry

Dosage form: lozenge
Ingredients: Benzocaine 15mg, Menthol, Unspecified Form 3.6mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-722

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.

Cēpacol®
Extra Strength* Sore Throat sugar free cherry

Drug Facts

Active ingredients (in each lozenge)Purposes
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

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 red no. 33, FD&C red no. 40, 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

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

NDC 63824-722-16
READ ALL INFORMATION

sugar free
Cēpacol®
EXTRA STRENGTH*

1 LOZENGE
EVERY
2
hours

#1
DOCTOR
RECOMMENDED

SORE THROAT

Benzocaine 15 mg • Menthol 3.6 mg | Oral Pain Reliever

  • Relieves Sore Throat Pain
  • Fast Acting
  • Maximum Numbing

16 Lozenges
cherry

*based on amount of benzocaine per dose.

CEPACOL   EXTRA STRENGTH SORE THROAT SUGAR FREE CHERRY
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-722
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine15 mg
Menthol, Unspecified Form (Menthol, Unspecified Form) Menthol, Unspecified Form3.6 mg
Inactive Ingredients
Ingredient NameStrength
D&C Red No. 33 
FD&C Red No. 40 
isomalt 
maltitol 
propylene glycol 
water 
sodium bicarbonate 
sucralose 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint CodeS
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-722-162 BLISTER PACK in 1 CARTON
18 LOZENGE in 1 BLISTER PACK
2NDC:63824-722-8324 CARTON in 1 CARTON
2NDC:63824-722-822 BLISTER PACK in 1 CARTON
28 LOZENGE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/15/2013
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 11/2016
 
Reckitt Benckiser LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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