Cepacol Sore Throat Plus Cough description, usages, side effects, indications, overdosage, supplying and lots more!

Cepacol Sore Throat Plus Cough

Combe Incorporated

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Cepacol Sore Throat and Cough



FULL PRESCRIBING INFORMATION

C ēpacol® S ore Throat + Cough Lozenges

Benzocaine 7.5 mg                              

Oral anesthetic

Dextromethorphan hydrobromide 5.0 mg            

Cough suppressant

temporarily

  • relieves occasional minor irritation, pain, sore mouth and sore throat
  • controls cough due to minor throat and bronchial irritation associated with a cold

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 t hroat w arning:  Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult a doctor promptly.  Do not use for more than 2 days or give to children under 6 years of age.

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

  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

ask a health professional before use.

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

Do not exceed recommended dosage.

  • 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, not to exceed 12 lozenges in any 24 hour period, or as directed by a doctor.
  • children under 6 years of age: do not use.
  • store at room temperature (68-77°F) (20-25°C)   
  • protect contents from humidity

blue 1, cetylpyridinium chloride (Ceepryn®), flavor, glucose, potassium acesulfame, propylene glycol, red 40, sodium bicarbonate, sucrose

Maximum Numbing

Cēpacol ®

Sore Throat

+ Cough Relief

Oral Analgesic /   Cough Suppressant Lozenges

Numbs

Relieves Cough

Suppresses Cough

Mixed Berry

18 Lozenges

Cepacol Sore Throat Plus Cough

benzocaine and dextromethorphan hydrobromide LOZENGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11509-0020
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg

Inactive Ingredients

Ingredient Name Strength
D&C Blue No. 1
cetylpyridinium chloride
ANHYDROUS DEXTROSE
ACESULFAME POTASSIUM
propylene glycol
D&C Red No. 40
SODIUM BICARBONATE
SUCROSE

Product Characteristics

Color Size Imprint Code Shape
RED 18 mm C ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 9 in 1 BLISTER PACK
2 NDC:11509-0020-1 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-07-28


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Be sure to consult your doctor before taking any medication!
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