Diabetic Tussin Expectorant
FDA Label NDC 76413-335

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Diabetic Tussin Expectorant (NDC 76413-335). 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 5 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 5 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

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 118 Ml Bottle Label

Active Ingredient (In Each 5 Ml)

Guaifenesin 100 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 & children 12 years and over	10 mL - 20 mL (2 - 4 teaspoonfuls)
children 6 years to under 12 years	5 mL - 10 mL (1 - 2 teaspoonfuls)
children 2 years to under 6 years	2.5 mL - 5 mL (½ - 1 teaspoonful)
children under 2 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 1-800-899-3116, 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 #063:05 10/11