DIABETIC TUSSIN SORE THROAT AND COUGH CHERRY- benzocaine and dextromethorphan hbr lozenge

Diabetic Tussin Sore Throat and Cough Cherry by

Drug Labeling and Warnings

Diabetic Tussin Sore Throat and Cough Cherry by is a Otc medication manufactured, distributed, or labeled by MEDTECH PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active ingredients (in each lozenge)

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

Questions?

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

Principal Display Panel

Diabetic Tussin® Sore Throat & Cough Lozenges

Menthol/Benzocaine Oral Pain Relievers Dextromethorphan HBr/Cough Suppressant

Wild cherry 15 lozenges

INGREDIENTS AND APPEARANCE

DIABETIC TUSSIN SORE THROAT AND COUGH CHERRY 
benzocaine and dextromethorphan hbr lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61787-070
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	6 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	22mm
Flavor	CHERRY	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61787-070-15	3 in 1 CARTON	06/20/2024
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/20/2024

Labeler - MEDTECH PRODUCTS INC (114707784)