Diabetic Tussin Sore Throat Cherry Lozenge

Diabetic Tussin Sore Throat Cherry Lozenge
SPL v1
SPL
SPL Set ID e9327079-e0fc-4c95-b1d5-bc1b74870c9b
Route
ORAL
Published
Effective Date 2024-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: oval Color: red Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-20

Description

Benzocaine 6 mg......................................................... Oral pain reliever Dextromethorphan HBr 5 mg .…………………………..Cough suppressant Menthol 10 mg……………………………,…….………. Oral pain reliever

Purpose

Benzocaine 6 mg......................................................... Oral pain reliever Dextromethorphan HBr 5 mg .…………………………..Cough suppressant Menthol 10 mg……………………………,…….………. Oral pain reliever


Medication Information

Purpose

Benzocaine 6 mg......................................................... Oral pain reliever

Dextromethorphan HBr 5 mg .…………………………..Cough suppressant

Menthol 10 mg……………………………,…….………. Oral pain reliever

Description

Benzocaine 6 mg......................................................... Oral pain reliever Dextromethorphan HBr 5 mg .…………………………..Cough suppressant Menthol 10 mg……………………………,…….………. Oral pain reliever

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
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 a doctor promptly. Do not use more than 2 days or give 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: Ask a doctor before use.

  • 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?

1-800-579-8327 http://diabetictussin.com

Other Information
  • Store between 15° - 30°C (59° - 86°F)

  • Protect from moisture

  • Check expiration date before using
Inactive Ingredients:

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

Principal Display Panel

Diabetic Tussin® Sore Throat & Cough Lozenges

Menthol/Benzocaine Oral Pain Relievers 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 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 fever, rash, or persistent headache. These could be signs 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
Purpose

Benzocaine 6 mg......................................................... Oral pain reliever

Dextromethorphan HBr 5 mg .…………………………..Cough suppressant

Menthol 10 mg……………………………,…….………. 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 a doctor promptly. Do not use more than 2 days or give 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: Ask a doctor before use.

  • 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?

1-800-579-8327 http://diabetictussin.com

Other Information (Other information)
  • Store between 15° - 30°C (59° - 86°F)

  • 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, glycerin, hydrogenated starch hydrolysate, isomalt, soy lecithin, sucralose, water

Principal Display Panel

Diabetic Tussin® Sore Throat & Cough Lozenges

Menthol/Benzocaine Oral Pain Relievers 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 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 fever, rash, or persistent headache. These could be signs of a serious condition.

Advanced Ingredient Data


Raw Label Data

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