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Mucus Relief D
Guaifenesin and Pseudoephedrine HCL · Tablet, Extended Release
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Adrenergic alpha-Agonists [MoA] | MoA | All 85 members |
| Decreased Respiratory Secretion Viscosity [PE] | PE | All 52 members |
| Expectorant [EPC] | EPC | All 48 members |
| Increased Respiratory Secretions [PE] | PE | All 48 members |
| alpha-Adrenergic Agonist [EPC] | EPC | All 85 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | Over-the-counter | — | ||
| 208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 1 | Labeling | Approved | April 23, 2018 | Standard |
| Original application | 1 | Approved | December 29, 2017 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251210). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse(s) ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive ■ temporarily relieves nasal congestion due to: ■ common cold ■ hay fever ■ upper respiratory allergies ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ temporarily relieves sinus congestion and pressure
Purpose
openFDA Drug LabelingPurpose Expectorant and Nasal Decongestant
Dosage and Administration
openFDA Drug LabelingDirections ■ do not crush, chew, or break tablet ■ take with a full glass of water ■ this product can be administered without regard for timing of meals ■ children under 12 years of age: do not use For 600 mg/60 mg ■ adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours For 1200 mg/120 mg ■ adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
Warnings
openFDA Drug LabelingWarnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough accompanied by too much phlegm (mucus) When using this product ■ do not use more than directed Stop use and ask doctor if ■ you get nervous, dizzy, or sleepless ■ symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. Pregnancy/Breastfeeding 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 (1-800-222-1222).
Do Not Use
openFDA Drug LabelingDo not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough accompanied by too much phlegm (mucus)
Stop Use
openFDA Drug LabelingStop use and ask doctor if ■ you get nervous, dizzy, or sleepless ■ symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.
Active Ingredient
openFDA Drug LabelingActive ingredients (in each extended-release tablet) Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: GUAIFENESIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 69842-211-24 | 69842-211 | CVS Health Corp | 4 BLISTER PACK in 1 CARTON (69842-211-24) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 8, 2019 |
| 69842-211-28 | 69842-211 | CVS Health Corp | 2 BLISTER PACK in 1 CARTON (69842-211-28) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 31, 2020 |
| 11822-7399-4 | 11822-7399 | Rite Aid Corporation | 4 BLISTER PACK in 1 CARTON (11822-7399-4) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | January 15, 2020 |
| 11822-7399-6 | 11822-7399 | Rite Aid Corporation | 2 BLISTER PACK in 1 CARTON (11822-7399-6) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 31, 2020 |
| 49035-261-12 | 49035-261 | Wal-mart Stores, Inc. | 2 BLISTER PACK in 1 CARTON (49035-261-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 3, 2020 |
| 0363-1604-15 | 0363-1604 | Walgreens Company | 1 BLISTER PACK in 1 CARTON (0363-1604-15) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 30, 2020 |
| 0363-1604-20 | 0363-1604 | Walgreens Company | 2 BLISTER PACK in 1 CARTON (0363-1604-20) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 13, 2019 |
| 0363-1604-37 | 0363-1604 | Walgreens Company | 2 BLISTER PACK in 1 CARTON (0363-1604-37) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 30, 2020 |
| 0363-1604-40 | 0363-1604 | Walgreens Company | 4 BLISTER PACK in 1 CARTON (0363-1604-40) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 13, 2019 |
| 0363-7064-24 | 0363-7064 | Walgreens Company | 4 BLISTER PACK in 1 CARTON (0363-7064-24) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 10, 2019 |
| 0363-7064-30 | 0363-7064 | Walgreens Company | 2 BLISTER PACK in 1 CARTON (0363-7064-30) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 30, 2020 |
| 69842-211 | 69842-211 | CVS Health Corp | — | July 8, 2019 |
| 11822-7399 | 11822-7399 | Rite Aid Corporation | — | January 15, 2020 |
| 49035-261 | 49035-261 | Wal-mart Stores, Inc. | — | April 3, 2020 |
| 0363-1604 | 0363-1604 | Walgreens Company | — | August 13, 2019 |
| 0363-7064 | 0363-7064 | Walgreens Company | — | July 10, 2019 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.