Guaifenesin is an over-the-counter medicine (Expectorant). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Brand names
- Mucus Relief, Mucinex, Maximum Strength Mucus Relief, Mucus Relief Extended Release, Mucus Relief Extended Release Maximum Strength, Mucus Relief Maximum Strength, Chest Congestion Relief, Mucus Relief ER, Childrens Giltuss EX Expectorant, Geri-Tussin, Giltuss EX Expectorant, Mucus And Chest Congestion
- Drug class
- Expectorant
- Taken
- Oral
- Label
- Reckitt Benckiser LLC, revised May 27, 2026 · full label on DailyMed
Purpose
Expectorant
What it is used for
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Active ingredient
Guaifenesin 1200 mg
Do not use
for children under 12 years of age
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 too much phlegm (mucus)
Stop use and ask a doctor if
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Warnings
Do not use for children under 12 years of age 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 too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. 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.
Pregnancy or breastfeeding
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.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Guaifenesin in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0808-2023
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Guaifenesin
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 47f5323c-ee3a-400d-b133-31d9c286fafd.