Mucus Relief Tablet
FDA Label NDC 50804-371

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Good Sense for the product Mucus Relief (NDC 50804-371). 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(s), purpose, use(s), ask a doctor before use if, when using this product, stop use and ask a doctor if, pregnancy/breastfeeding, 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 Ingredient(s)

→ Purpose

→ Use(s)

→ Ask A Doctor Before Use If

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Pregnancy/breastfeeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Storage

→ Inactive Ingredients

→ Questions

→ Principal Display Panel

Active Ingredient(S)

Guaifenesin 400 mg

Purpose

Expectorant

Use(S)

helps loosen phlegm (mucus)and thin bronchial secretions to make
coughs more productive to rid the bronchial passageway of bothersome mucus

Ask A Doctor Before Use If

you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough accompanied by excessive phlegm (mucus)

When Using This Product

do not exceed recommended dosage

do not use for more than 7 days

Stop Use And Ask A Doctor If

cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

Pregnancy/Breastfeeding

ask a healthcare professional before use.

Keep Out Of Reach Of Children

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children12 years of age and older: Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under12 years of age: do not use