Diabetic Tussin Expectorant
FDA Label NDC 61787-514

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 Expectorant (NDC 61787-514). 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 ingredient (in each 10 ml), purpose, uses, 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., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 10 Ml)

Guaifenesin 200 mg

Purpose

Expectorant

Uses

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

Ask A Doctor Before Use If You Have:

  • a cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough such 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

    10 mL - 20 mL (2 - 4 teaspoons)

    Children under 12 years

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

Questions Or Comments?

Call 1-800-579-8327, serious side effects associated with use of this product may be reported to this number.

Rev #0514:00 04/19

Package/Label Principal Display Panel

SUGAR & ALCOHOL FREE!

Specifically Formulated for Diabetics

Diabetic Tussin®

CHEST CONGESTION

Guaifenesin (Expectorant)

Thins & Loosens Mucus

4 FL OZ (118 mL)

* Please review the disclaimer below.