Quick answers
- What is Guaifenesin used for?
- The FDA-approved label (Mucus Relief, Bryant Ranch Prepack, June 2, 2025) says: “USE(S) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Guaifenesin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Guaifenesin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Guaifenesin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Guaifenesin?
- 1 company lists prescription products of Guaifenesin in the FDA NDC Directory, including Bryant Ranch Prepack.
What Guaifenesin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
USE(S) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
— FDA label: Mucus Relief, Bryant Ranch Prepack, effective June 2, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Mucus Relief |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA209215Guardian Drug · September 6, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 636522 |
|---|---|
| SPL set ID of the quoted label | c648e711-e944-4574-83b3-ccce8732384e |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | GUAIFENESIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mucus Relief, Bryant Ranch Prepack, effective June 2, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →