Diabetic Tussin Dm Maximum Strength
FDA Label NDC 61787-064

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Health Care Products for the product Diabetic Tussin Dm Maximum Strength (NDC 61787-064). 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 active ingredients (in each 5 ml), purposes, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 5 Ml)

Dextromethorphan hydrobromide 10 mg

Guaifenesin 200 mg

Purposes

Cough Suppressant

Expectorant

Uses

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

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 under 12 years of age

    ask a doctor

Other Information

  • Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
  • store at room temperature 20-25°C (68-77°F)
  • keep tightly closed

Inactive Ingredients

Acesulfame K, artificial cherry & vanilla flavors, aspartame, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, and purified water. Citric acid may be used to adjust pH.

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 #064:03 12/11

Package Principal Display Panel

Image Of Carton (237 mL)

Image Of Carton (237 mL)

NDC 61787-064-08

Diabetic Tussin®

DM MAXIMUM STRENGTH

Cough Suppressant & Expectorant

RELIEVES COUGHS

SOOTHES THROAT

RELIEVES CHEST CONGESTION

Liquid

No Sodium, Dye, Sorbitol, Fructose

SAFE FOR DIABETICS

SUGAR & ALCOHOL FREE!

GLUTEN FREE

8 FL OZ (237 mL)

* Please review the disclaimer below.