Mucosa Guifenesin Tablet
FDA Label NDC 54257-776

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Magno-humphries, Inc. for the product Mucosa Guifenesin (NDC 54257-776). 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 tablet), purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

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

Warnings

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.

If Pregnant Or Breast-Feeding,

ask a health 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 children 12 years of age and older: Take one tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
 Children under 12 years of age: Do not use

Other Information

  • store at controlled room temperature 15° to 30°C (59° to 86°F)

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, microcrystalline cellulose, silicon dioxide, stearic acid.

Questions?

call toll-free 1-800-935-6737

Package Labeling:

Label10 (Label10)

Label10 (Label10)

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