CEPACOL  EXTRA STRENGTH SORE THROAT AND COUGH- benzocaine and dextromethorphan hydrobromide lozenge 
Reckitt Benckiser 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 and Cough

Drug Facts

Active ingredients (in each lozenge) Purposes
Benzocaine 7.5 mg Oral pain reliever
Dextromethorphan hydrobromide 5 mg Cough suppressant

Uses

temporarily relieves

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.

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 occurs with too much 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

Other information

Inactive ingredients

FD&C blue no. 1, 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 63824-744-16

READ ALL INFORMATION

TAKE
EVERY
4
hours

Cēpacol®
EXTRA STRENGTH*

#1
DOCTOR
RECOMMENDED

SORE THROAT & COUGH
Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant

16 Lozenges mixed berry

*based on amount of benzocaine per adult dose.

Principal Display Panel - 16 Lozenge Blister Pack Carton
CEPACOL   EXTRA STRENGTH SORE THROAT AND COUGH
benzocaine and dextromethorphan hydrobromide lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-744
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
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
Color RED Score no score
Shape ROUND Size 18mm
Flavor BERRY Imprint Code S
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-744-16 2 in 1 CARTON 05/05/2014
1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:63824-744-94 1 in 1 CARTON 05/05/2014
2 4 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 05/05/2014
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 6/2016
Document Id: 40c3b05f-7d7b-4d58-9a25-181eceba0740
Set id: c0cc32db-90f0-4106-8538-89821083ece1
Version: 3
Effective Time: 20160622
 
Reckitt Benckiser LLC