Diabetic Tussin Cough Drops

Dosage form: lozenge
Ingredients: MENTHOL 5.8mg
Labeler: Health Care Products
NDC Code: 61787-058

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each cough drop)

Menthol 5.8 mg

Purpose

Cough suppressant/Oral anesthetic

Uses

temporarily relieves:

  • coughs as may occur with a cold or inhaled irritants
  • occasional minor irritation and sore throat

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

When using this product
  • do not exceed recommended dosage

Stop use and consult a doctor if
  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

Directions
adults & children 3 years & over:allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.
children under 3 years:ask a doctor

Other Information
  • 6 calories per drop
  • Phenylketonurics: contains phenylalanine 2 mg per drop.
  • product may be useful for diabetics on the advice of a doctor.
  • Dietary Exchange* information:

    1 Drop = FREE Exchange

    10 Drops = 1 Fruit

    * The dietary exchanges are based on the Exchange List for Meal Planning, ©1995 American Diabetes Association and the American Dietetic Association.

Inactive Ingredients

acesulfame potassium eucalyptus oil, flavoring hydrogenated starch hydrolysate, isomalt, sucralose and water. Soybean oil used as a processing aid.

Questions or comments?

Call: 1-800-899-3116, Mon-Thurs. 9:00 am - 5:00 pm EST, Fri. 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.


Rev. 058:05 4/09

Package/Label Principal Display Panel

Diabetic Tussin® brand

COUGH DROPS

COUGH SUPPRESSANT/ORAL ANESTHETIC

MENTHOL EUCALYPTUS

Controls Coughs And Soothes Sore Throats

 

 COMPLETELY SUGAR FREE!

 

25 COUGH DROPS

DIABETIC TUSSIN COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-058
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.8 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
EUCALYPTUS OIL 
ISOMALT 
SUCRALOSE 
WATER 
SOYBEAN OIL 
Product Characteristics
ColorWHITE (colorless to opaque) Scoreno score
ShapeOVALSize23mm
FlavorMENTHOLImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:61787-058-2525 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/03/200104/30/2014
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIOperations
BestSweet Inc002149136MANUFACTURE(61787-058)

Revised: 07/2011
 
Health Care Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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