Cepacol Sore Throat and Cough

Drug Labeling and Warnings

Drug Details [pdf]

SORE THROAT AND COUGH- benzocaine and dextromethorphan hydrobromide lozenge 
Rugby Laboratories

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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Cepacol Sore Throat and Cough

Rugby® Sore Throat & Cough Lozenges

Active Ingredients (in each lozenge)

Benzocaine 7.5 mg                              

Purpose

Oral pain reliever

Active Ingredients (in each lozenge)

Dextromethorphan hydrobromide 5 mg            

Purpose

Cough suppressant

Uses

temporarily relieves these symptoms:

• occasional minor irritation, sore mouth and sore throat
• pain associated with cander sores
• cough due to minor throat and bronchial irritation as may occur with 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 this product if

you are 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 MAIO, ask a doctor or pharmacist before taking the product.

Ask a doctor before use if you have

• cough that is accompanied by excessive phlegm (mucus)
  
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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 presistent 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 reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

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 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

• store at room temperature (68-77°F) (20-25°C)   
  
• protect from moisture

Inactive ingredients

acesulfame pottasium, corn syrup, FD&C Blue 1, FD&C Red 40, natural and artificial flavors (medium chain triglycerides), proplylene glycol, sucrose, and water, soybean oil and  corn starch used as processing aids.

Principal Display Panel

Rugby ®

Sore Throat & Cough Lozenges

Oral Pain Reliver/Cough Suppressant Lozenges

Temporary relieves:

• Minor sore throat and mouth irritation

• Cough due to minor throat and bronchial irritation

Mixed Berry Flavor

18 Lozenges

SORE THROAT AND COUGH 
benzocaine and dextromethorphan hydrobromide lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1045
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)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	18mm
Flavor	BERRY	Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1045-21	1 in 1 CARTON	11/04/2014	06/30/2017
1		18 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	11/04/2014	06/30/2017

Labeler - Rugby Laboratories (079246066)

Revised: 10/2019

Document Id: 951b0171-8b55-967d-e053-2a95a90a17e1

34390-5

Set id: aeb7f1b6-edf1-45b7-9bc8-903b3b29b52d

Version: 8

Effective Time: 20191017