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Cepacol Sore Throat by Reckitt Benckiser LLC

Dosage form: lozenge
Ingredients: Benzocaine 15mg, Menthol 3.6mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-721

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®
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
  • tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
  • store at room temperature 20-25°C (68-77°F)
  • protect contents from humidity

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

PRINCIPAL DISPLAY PANEL- 16 Lozenge Carton

NDC 63824-721-16

NEW FORMULA

Cēpacol®

SORE THROAT

Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Reliever

  • Instant Acting
  • Maximum Strength Numbing

16 Lozenges

SUGAR FREE
cherry

CEPACOL   SORE THROAT
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-721
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine15 mg
Menthol (Menthol) Menthol3.6 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:63824-721-162 BLISTER PACK (BLISTER PACK) in 1 CARTON
18 LOZENGE (LOZENGE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/15/2011
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 12/2011
 
Reckitt Benckiser LLC

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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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