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mucus D
guaifenesin and pseudoephedrine hydrochloride · Tablet, Multilayer, 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 |
|---|---|---|---|---|---|---|---|
| 214407-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | Over-the-counter | — | ||
| 214407-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | February 1, 2022 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260409). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome 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 LabelingPurposes Expectorant Nasal Decongestant
Dosage and Administration
openFDA Drug LabelingDirections • do not crush, chew, or break extended-release tablet • take with a full glass of water • this product can be administered without regard for timing of meals • adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours • children under 12 years of age: do not use
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 you have • 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 a 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. 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 (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 you have • 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 a 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 bi-layer tablet) Guaifenesin 1200 mg Pseudoephedrine HCl 120 mg
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 |
|---|---|---|---|---|
| 51316-345-62 | 51316-345 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4 BLISTER PACK in 1 CARTON (51316-345-62) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | April 4, 2025 |
| 51316-878-68 | 51316-878 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2 BLISTER PACK in 1 CARTON (51316-878-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | April 4, 2025 |
| 51316-878-89 | 51316-878 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1 BLISTER PACK in 1 CARTON (51316-878-89) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | April 4, 2025 |
| 30142-739-68 | 30142-739 | Kroger Company | 2 BLISTER PACK in 1 CARTON (30142-739-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | November 4, 2025 |
| 30142-739-89 | 30142-739 | Kroger Company | 1 BLISTER PACK in 1 CARTON (30142-739-89) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | January 26, 2026 |
| 0113-8307-68 | 0113-8307 | L. Perrigo Company | 2 BLISTER PACK in 1 CARTON (0113-8307-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | October 3, 2025 |
| 0113-8911-62 | 0113-8911 | L. Perrigo Company | 4 BLISTER PACK in 1 CARTON (0113-8911-62) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | October 3, 2025 |
| 79481-0119-0 | 79481-0119 | Meijer, Inc. | 4 BLISTER PACK in 1 CARTON (79481-0119-0) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | August 22, 2023 |
| 79481-0709-1 | 79481-0709 | Meijer, Inc. | 1 BLISTER PACK in 1 CARTON (79481-0709-1) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | January 7, 2025 |
| 51316-345 | 51316-345 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | April 4, 2025 |
| 51316-878 | 51316-878 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | April 4, 2025 |
| 30142-739 | 30142-739 | Kroger Company | — | November 4, 2025 |
| 0113-8307 | 0113-8307 | L. Perrigo Company | — | October 3, 2025 |
| 0113-8911 | 0113-8911 | L. Perrigo Company | — | October 3, 2025 |
| 79481-0119 | 79481-0119 | Meijer, Inc. | — | August 22, 2023 |
| 79481-0709 | 79481-0709 | Meijer, Inc. | — | January 7, 2025 |
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 · 10 sections on this page.