Cepacol description, usages, side effects, indications, overdosage, supplying and lots more!

Cepacol

Reckitt Benckiser LLC

  • 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
Cēpacol Extra Strength* Sore Throat mixed berry

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

  • 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, 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

Made in England

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

NDC 63824-743-16

Cēpacol®
EXTRA STRENGTH*

TAKE
EVERY
4
hours

SORE THROAT & COUGH

Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant

  • Relieves Sore Throat Pain
  • Fast Acting
  • Maximum Numbing

16
Lozenges
mixed berry

*based on amount of benzocaine per adult dose.

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

Cepacol

BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE LOZENGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-743
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
ACESULFAME POTASSIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
DEXTROSE
propylene glycol
water
SODIUM BICARBONATE
SUCROSE

Product Characteristics

Color Size Imprint Code Shape
RED 18 mm S ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:63824-743-16 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-07-15


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Be sure to consult your doctor before taking any medication!
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