CEPACOL  EXTRA STRENGTH SORE THROAT AND COUGH- benzocaine and dextromethorphan hydrobromide lozenge 
RB Health (US) 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 & Cough

Drug Facts

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

Uses

For the temporary relief of occasional

Warnings

Methemoglobinemia warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. 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 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, swelling, 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.
  • for teething
  • in children under 6 years of age

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 condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of 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 of age 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 as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor or dentist
children 6 to under 12 years of age take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist
children under 6 years of age do not use

Other information

Inactive ingredients

FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, purified water, sucralose

Questions?

1-866-682-4639
You may also report side effects to this phone number.

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

NDC 63824-744-16
READ ALL WARNINGS

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
3 NDC:63824-744-36 3 in 1 CARTON 05/01/2019
3 12 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 - RB Health (US) LLC (081049410)

Revised: 12/2018
Document Id: a61ce3b6-b6d6-4687-bb19-559cf000b244
Set id: c0cc32db-90f0-4106-8538-89821083ece1
Version: 4
Effective Time: 20181214
 
RB Health (US) LLC