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Cepacol SORE THROAT AND COUGH by Reckitt Benckiser LLC

Medically reviewed on December 20, 2017

Dosage form: lozenge
Ingredients: Benzocaine 7.5mg, Dextromethorphan Hydrobromide 5mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-741

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 AND COUGH

Drug Facts

Active ingredients (in each lozenge)Purpose
Benzocaine 7.5 mgOral pain reliever
Dextromethorphan hydrobromide 5 mgCough suppressant

Uses

temporarily relieves

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores
  • cough due to minor throat and bronchial irritation as may occur with the common cold

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 6 years of age.

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that is accompanied by excessive phlegm (mucus)

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 develops
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness

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 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
  • children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
  • children under 6 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

acesulfame potassium, cetylpyridinium chloride, FD&C blue #1, FD&C red #40, flavors, glucose, propylene glycol, purified water, sodium bicarbonate, sucrose

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 Lozenges Carton

NDC 63824-741-16

Cēpacol®

SORE THROAT & COUGH

Benzocaine 7.5 mg
Oral Pain Reliever

Dextromethorphan HBr 5 mg
Cough Suppressant


  • Instant Acting
  • Maximum Strength Numbing

16 Lozenges

mixed berry

CEPACOL   SORE THROAT AND COUGH
benzocaine and dextromethorphan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-741
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine7.5 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide5 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium 
cetylpyridinium chloride 
FD&C blue no. 1 
FD&C red no. 40 
dextrose 
propylene glycol 
water 
sodium bicarbonate 
sucrose 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize18mm
FlavorBERRYImprint CodeS
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-741-162 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 FINALpart35609/19/2011
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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