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    HomeMedication GuideGuaifenesin Safety
    Expectorant

    Guaifenesin: What to Know Before You Take It

    Also sold as Mucinex

    What Guaifenesin Is Used For

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

    Warnings

    Warnings Do not use ■ for children under 12 years of age

    Most-Reported Side Effects

    Based on 199,480 reports in the FDA Adverse Event Reporting System (FAERS). Reports do not prove the drug caused the effect.

    drug ineffective21,981fatigue18,567nausea15,440headache15,235pain14,521diarrhoea13,706off label use13,306dyspnoea12,592arthralgia10,981dizziness10,137vomiting8,964asthenia8,507

    Explore full Guaifenesin safety data in our free FDA Safety Explorer

    FDA Recalls (showing 12 of 17)

    Class IIICompletedJan 7, 2025

    Superpotent; sodium benzoate preservative

    Recalling firm: PAI Holdings, LLC. dba Pharmaceutical Associates Inc

    Class IITerminatedNov 14, 2024

    CGMP Deviations: Released product should have been rejected.

    Recalling firm: LNK International, Inc.

    Class IIIOngoingSep 25, 2024

    Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

    Recalling firm: Denison Pharmaceuticals, LLC

    Class IIIOngoingSep 25, 2024

    Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

    Recalling firm: Denison Pharmaceuticals, LLC

    Class ITerminatedApr 20, 2023

    Product mix-up: incorrect product was found inside the G-Supress DX product carton.

    Recalling firm: Novis PR, LLC dba Kramer Novis

    Class IIITerminatedOct 11, 2022

    Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

    Recalling firm: LNK International, Inc.

    Class IITerminatedAug 24, 2021

    Microbial Contamination of Non-Sterile Products

    Recalling firm: Efficient Laboratories, Inc.

    Class IITerminatedAug 24, 2021

    Microbial Contamination of Non-Sterile Products

    Recalling firm: Efficient Laboratories, Inc.

    Class IITerminatedAug 24, 2021

    Microbial Contamination of Non-Sterile Products

    Recalling firm: Efficient Laboratories, Inc.

    Class IITerminatedAug 24, 2021

    Microbial Contamination of Non-Sterile Products

    Recalling firm: Efficient Laboratories, Inc.

    Class IITerminatedJun 16, 2020

    Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

    Recalling firm: Glaxosmithkline Consumer Healthcare Holdings

    Class IITerminatedJun 21, 2019

    CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

    Recalling firm: Pharma-Natural Inc.

    This information is educational — not medical advice.

    This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.

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