Tussin Chest
FDA Label NDC 67510-0526

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Tussin Chest (NDC 67510-0526). 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, purpose, uses, warnings, 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 5mL tsp)


Guaifenesin, USP 100mg


Purpose

Expectorant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Warnings


Ask A Doctor Before Use If You Have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic 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 is accompanied by fever, rash, or persistent headache. 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

  • do not take more than 6 doses in any 24-hour period

    • Age
    		Dose
    adults and children 12 years and over
    		2-4 tsp every 4 hours
    children 6 years to under 12 years
    		1-2 tsp every 4 hours
    children 2 years to under 6 years
    		1/2-1 tsp every 4 hours
    under 2 years
    		ask a doctor

Other Information

  • each teaspoon contains:sodium 1mg
  • store at 20-25°C (68-77°F)
  • alcohol-free
  • dosage cup provided

Inactive Ingredients

cherry flavor, citric acid, FD and C red no. 40, glycerin, high fructose corn syrup, sucrose, sucralose, menthol, propylene glycol, purified water, xanthan gum, polysorbate, saccharin sodium, sodium benzoate

Package Label

Tussin Chest

Image Of Carton Label (Tussinchest.carton)

Image Of Carton Label (Tussinchest.carton)

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