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    HomeMedication GuideGuaifenesin safety
    Expectorant

    Guaifenesin: What to Know Before You Take It

    Also known as Mucinex

    A patient-focused safety profile with information from public regulatory sources.

    Reviewed by the OmniRx Health clinical team•Last reviewed Jul 4, 2026

    In plain language

    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

    Read before you decide

    Risks and precautions

    Risks and warnings

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

    FDA safety data

    Most-reported side effects

    Based on 199,480 FAERS reports. Reports do not prove the drug caused the effect.

    drug ineffective 21,981fatigue 18,567nausea 15,440headache 15,235pain 14,521diarrhoea 13,706off label use 13,306dyspnoea 12,592arthralgia 10,981dizziness 10,137vomiting 8,964asthenia 8,507
    Explore full FDA safety data

    Regulatory record

    FDA recalls (17)

    Class IIICompleted · Jan 7, 2025

    Superpotent; sodium benzoate preservative

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

    Class IITerminated · Nov 14, 2024

    CGMP Deviations: Released product should have been rejected.

    Recalling firm: LNK International, Inc.

    Class IIIOngoing · Sep 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 IIIOngoing · Sep 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 ITerminated · Apr 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 IIITerminated · Oct 11, 2022

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

    Recalling firm: LNK International, Inc.

    Class IITerminated · Aug 24, 2021

    Microbial Contamination of Non-Sterile Products

    Recalling firm: Efficient Laboratories, Inc.

    Class IITerminated · Aug 24, 2021

    Microbial Contamination of Non-Sterile Products

    Recalling firm: Efficient Laboratories, Inc.

    Class IITerminated · Aug 24, 2021

    Microbial Contamination of Non-Sterile Products

    Recalling firm: Efficient Laboratories, Inc.

    Class IITerminated · Aug 24, 2021

    Microbial Contamination of Non-Sterile Products

    Recalling firm: Efficient Laboratories, Inc.

    Class IITerminated · Jun 16, 2020

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

    Recalling firm: Glaxosmithkline Consumer Healthcare Holdings

    Class IITerminated · Jun 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.

    Common questions

    Patient questions

    What is Guaifenesin prescribed for?

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

    What are the key warnings and safety precautions for Guaifenesin?

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

    Does Guaifenesin interact with other medications or foods?

    Guaifenesin has 0 documented drug interaction(s) and 0 food interaction(s) in clinical databases. Always provide your complete medication list to your clinician.

    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.

    Have medication questions?

    A licensed OmniRx provider can review your health history and medication list. Availability and treatment options are determined individually.