Chloraseptic Sugar Free Lozenges

Chloraseptic Sugar Free Lozenges
SPL v6
SPL
SPL Set ID 34e4234c-ed61-4795-99fe-d281cdb0af88
Route
ORAL
Published
Effective Date 2025-10-23
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 Lecithin, Soybean Sucralose Water

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: oval Color: red Size: 4 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-08-01

Description

Drug Facts

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

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

Drug Facts

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. If a skin reaction occurs, stop use and seek medical help right away.

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: 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.

  • for teething

  • in children under 6 years of age
Questions?

1-800-552-7932 C hloraseptic.com

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

  • Protect from moisture.

  • Check expiration date before using.
Active Ingredients

(in each lozenge)

Benzocaine 6 mg

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

Chloraseptic® T otal   Sugar Free

SORE TH ROAT + COUGH Lozenges

Benzocaine / Menthol / Oral Anesthetic/Analgesic

Dextromethorphan HBr /Cough Suppressant

Wild Cherry | 15 lozenges

When Using This Product

do not exceed recommended dosage.

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • a cough accompanied by excessive phlegm (mucus)
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)

Drug Facts

Purpose

Oral pain reliever

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. If a skin reaction occurs, stop use and seek medical help right away.

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: do not use.
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.

  • for teething

  • in children under 6 years of age
Questions?

1-800-552-7932 C hloraseptic.com

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

  • Protect from moisture.

  • Check expiration date before using.
Active Ingredients

(in each lozenge)

Benzocaine 6 mg

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)

Chloraseptic® T otal   Sugar Free

SORE TH ROAT + COUGH Lozenges

Benzocaine / Menthol / Oral Anesthetic/Analgesic

Dextromethorphan HBr /Cough Suppressant

Wild Cherry | 15 lozenges

When Using This Product (When using this product)

do not exceed recommended dosage.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

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

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • a cough accompanied by excessive phlegm (mucus)
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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