Diabetic Tussin DM

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Health Care Products
NDC Code: 61787-062

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 ingredients (in each 5 mL)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Purposes

Cough Suppressant

Expectorant

Uses
  • temporarily relieves cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Warnings

Do not use

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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • a cough that occurs with too much phlegm (mucus)
  • a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

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 right away.

Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours
adults & children 12 years & over 10 mL (2 teaspoonfuls)
children 6 years to under 12 years5 mL (1 teaspoonful)
children 2 years to under 6 years2.5 mL (½ teaspoonful)
children under 2 yearsask a doctor

Other information

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Storage
  • store at room temperature 20-25ºC (68-77ºF)
  • keep tightly closed

Inactive ingredients

Acesulfame potassium, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Questions and 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.

Package Principal Display Panel

NDC 61787-062-04

Diabetic Tussin® DM

Cough Suppressant / Expectorant

Relieves Coughs

Soothes Throat

Relieves Chest Congestion

Liquid

No Sodium, Dye, Codeine, Sorbitol, Fructose

Sugar & Alcohol Free!

Safe for Diabetics

4 Fl. Oz. (118 mL)

DIABETIC TUSSIN DM 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-062
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CHERRY 
VANILLA 
ASPARTAME 
HYPROMELLOSE 
MENTHOL 
METHYLPARABEN 
POTASSIUM SORBATE 
WATER 
ANHYDROUS CITRIC ACID 
Packaging
#Item CodePackage Description
1NDC:61787-062-041 BOTTLE (BOTTLE) in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/1997
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIOperations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE

Revised: 09/2010
 
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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