Cepastat Sore Throat And Cough

Cepastat Sore Throat And Cough
SPL v3
SPL
SPL Set ID 93f0e60f-4dda-4ec9-b391-e059a0876654
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 mg) Benzocaine (6 mg) Dextromethorphan (5 mg)
Inactive Ingredients
Acesulfame Potassium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Hydrogenated Starch Hydrolysate Isomalt Lecithin, Soybean Sucralose Water

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: oval Color: red Size: 4 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-01

Description

Tamper Evident:  Do not use if blister package with “ CĒPASTAT® ” name has been disturbed or opened. Drug Facts

Purpose

Oral Anesthetic/Analgesic


Medication Information

Purpose

Oral Anesthetic/Analgesic

Description

Tamper Evident:  Do not use if blister package with “ CĒPASTAT® ” name has been disturbed or opened. Drug Facts

Uses

Temporarily relieves

  • occasional minor irritation, pain, sore throat and sore mouth

  • cough due to minor throat and bronchial irritation as may occur with the common cold
Section 42229-5

Tamper Evident: Do not use if blister package withCĒPASTAT®name has been disturbed or opened.

Drug Facts

Warnings

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

Directions
  • Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours.

  • Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours.

  • Children under 6 years of age: consult a doctor.
Do Not Use
  • this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product. 

  • this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Questions?

1-800-552-7932 

Other Information
  • Store between 59ºF and 86ºF (15ºC - 30ºC).

  • Protect from moisture.

  • Check expiration date before using.
Inactive Ingredients

acesulfame potassium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerine, hydrogenated starch hydrolysate, isomalt, soy lecithin, sucralose, water

Principal Display Panel

CĒPASTAT ®  

SORE THROAT & COUGH

Menthol/Benzocaine | Oral Anesthetic/Analgesic

Dextromethorphan HBr 5 mg | Cough Suppressant

FAST ACTING

SORE THROAT & COUGH RELIEF



18 LOZENGES

CHERRY

SUGAR FREE

When Using This Product

do not exceed recommended dosage.

Keep Out of Reach of Children.

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

Active Ingredients (in Each Lozenge)

Benzocaine 6 mg

Stop Use and Ask A Dentist Or Doctor If
  • sore mouth symptoms do not improve in 7 days

  • irritation, pain or redness persists or worsens

  • swelling, rash or fever develops

  • cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.

Structured Label Content

Uses

Temporarily relieves

  • occasional minor irritation, pain, sore throat and sore mouth

  • cough due to minor throat and bronchial irritation as may occur with the common cold
Section 42229-5 (42229-5)

Tamper Evident: Do not use if blister package withCĒPASTAT®name has been disturbed or opened.

Drug Facts

Purpose

Oral Anesthetic/Analgesic

Warnings

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

Directions
  • Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours.

  • Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours.

  • Children under 6 years of age: consult a doctor.
Do Not Use (Do not use)
  • this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product. 

  • this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Questions?

1-800-552-7932 

Other Information (Other information)
  • Store between 59ºF and 86ºF (15ºC - 30ºC).

  • Protect from moisture.

  • Check expiration date before using.
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerine, hydrogenated starch hydrolysate, isomalt, soy lecithin, sucralose, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CĒPASTAT ®  

SORE THROAT & COUGH

Menthol/Benzocaine | Oral Anesthetic/Analgesic

Dextromethorphan HBr 5 mg | Cough Suppressant

FAST ACTING

SORE THROAT & COUGH RELIEF



18 LOZENGES

CHERRY

SUGAR FREE

When Using This Product (When using this product)

do not exceed recommended dosage.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredients (in Each Lozenge) (Active Ingredients (in each lozenge))

Benzocaine 6 mg

Stop Use and Ask A Dentist Or Doctor If (Stop use and ask a dentist or doctor if)
  • sore mouth symptoms do not improve in 7 days

  • irritation, pain or redness persists or worsens

  • swelling, rash or fever develops

  • cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.

Advanced Ingredient Data


Raw Label Data

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