Diabetic Tussin Sore Throat And Cough Cherry Lozenge
FDA Label NDC 61787-070

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc for the product Diabetic Tussin Sore Throat And Cough Cherry (NDC 61787-070). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a dentist or doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Purpose

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.

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

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)

When Using This Product

do not exceed recommended dosage.

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.

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.

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.

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

Diabetic Tussin® Sore Throat & Cough Lozengesmenthol/benzocaine Oral Pain Relievers   Dextromethorphan Hbr/cough Suppressantwild Cherry 15 Lozenges (Diabetic Tussin Sore Throat Cherry Lozenge 01)

Diabetic Tussin® Sore Throat & Cough Lozengesmenthol/benzocaine Oral Pain Relievers Dextromethorphan Hbr/cough Suppressantwild Cherry 15 Lozenges (Diabetic Tussin Sore Throat Cherry Lozenge 01)

* Please review the disclaimer below.