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Mucinex
Guaifenesin · Tablet, Extended Release
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Dextromethorphan Hydrobromide | 30 mg/1 | 1094538 | View |
| Guaifenesin | 1200 mg/1 | 359601 | View |
| Guaifenesin | 600 mg/1 | 359601 | View |
| Naproxen Sodium | 110 mg/1 | 849431 | View |
| Naproxen Sodium | 220 mg/1 | 849431 | View |
| Pseudoephedrine Hydrochloride | 120 mg/1 | 1305603 | View |
Forms, 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 |
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Decreased Respiratory Secretion Viscosity [PE] | PE | All 52 members |
| Expectorant [EPC] | EPC | All 48 members |
| Increased Respiratory Secretions [PE] | PE | All 48 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
| Sigma-1 Agonist [EPC] | EPC | All 44 members |
| Sigma-1 Receptor Agonists [MoA] | MoA | All 44 members |
| Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] | EPC | All 44 members |
| Uncompetitive NMDA Receptor Antagonists [MoA] | MoA | All 44 members |
| alpha-Adrenergic Agonist [EPC] | EPC | All 85 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 021282-001 | MUCINEX | TABLET, EXTENDED RELEASE | GUAIFENESIN | Over-the-counter | — | RLD | |
| 021282-002 | MUCINEX | TABLET, EXTENDED RELEASE | GUAIFENESIN | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 55 | Labeling | Approved | August 30, 2024 | Standard |
| Supplement | 54 | Labeling | Approved | February 19, 2021 | Standard |
| Supplement | 51 | Manufacturing (CMC) | Approved | April 2, 2020 | N/A |
| Supplement | 49 | Manufacturing (CMC) | Approved | October 27, 2017 | N/A |
| Supplement | 48 | Manufacturing (CMC) | Approved | July 3, 2017 | Standard |
| Supplement | 46 | Manufacturing (CMC) | Approved | October 19, 2015 | Standard |
| Supplement | 45 | Manufacturing (CMC) | Approved | March 9, 2015 | Standard |
| Supplement | 44 | Manufacturing (CMC) | Approved | September 10, 2014 | Standard |
| Supplement | 43 | Manufacturing (CMC) | Approved | May 22, 2014 | Standard |
| Supplement | 37 | Manufacturing (CMC) | Approved | May 12, 2011 | Standard |
| Supplement | 35 | Manufacturing (CMC) | Approved | March 11, 2011 | Standard |
| Supplement | 31 | Manufacturing (CMC) | Approved | November 24, 2009 | N/A |
| Supplement | 29 | Manufacturing (CMC) | Approved | April 3, 2009 | Standard |
| Supplement | 25 | Manufacturing (CMC) | Approved | August 20, 2008 | N/A |
| Supplement | 21 | Manufacturing (CMC) | Approved | September 6, 2007 | N/A |
| Supplement | 16 | Labeling | Approved | November 14, 2006 | Standard |
| Supplement | 11 | Manufacturing (CMC) | Approved | August 23, 2006 | N/A |
| Supplement | 1 | Manufacturing (CMC) | Approved | December 18, 2002 | Standard |
| Original application | 1 | Type 3 - New Dosage Form | Approved | July 12, 2002 | Standard |
Review documents
- 0 · Supplement · September 3, 2024
- 0 · Supplement · September 3, 2024
- 0 · Supplement · August 6, 2021
- 0 · Supplement · February 23, 2021
- 0 · Supplement · February 23, 2021
- 0 · Supplement · August 13, 2020
- 0 · Supplement · September 30, 2019
- 0 · Supplement · September 30, 2019
- 0 · Supplement · September 30, 2019
- 0 · Supplement · September 30, 2019
- 0 · Supplement · September 30, 2019
- 0 · Supplement · June 19, 2018
- 0 · Supplement · July 6, 2017
- 0 · Supplement · July 6, 2017
- 0 · Supplement · March 7, 2014
- 0 · Supplement · March 7, 2014
- 0 · Supplement · April 7, 2009
- 0 · Supplement · August 22, 2008
- 0 · Supplement · September 7, 2007
- 0 · Supplement · September 7, 2007
- 0 · Supplement · November 22, 2006
- 0 · Supplement · September 18, 2006
- 0 · Supplement · December 18, 2002
- 0 · Original application · November 25, 2002
- 0 · Original application · July 12, 2002
- 0 · Original application · July 12, 2002
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260629). 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: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep ■ minor aches and pains due to headache and the common cold ■ temporarily reduces fever
Purpose
openFDA Drug LabelingPurposes (in each extended-release tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*........Pain reliever/fever reducer Pseudoephedrine HCl 120 mg, extended-release..................................Nasal decongestant *nonsteroidal anti-inflammatory drug
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 the timing of meals adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours. children under 12 years of age: do not use
Warnings
openFDA Drug LabelingWarnings Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ for children under 12 years of age ■ right before or after heart surgery ■ 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 ■ the stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ■ you are taking a diuretic ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ you have a cough accompanied by too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ■ under a doctor’s care for any serious condition ■ taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin ■ taking any other drug When using this product ■ take with food or milk if stomach upset occurs Stop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ you have difficulty swallowing ■ it feels like the pill is stuck in your throat ■ redness or swelling is present in the painful area ■ any new symptoms appear ■ 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. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Do Not Use
openFDA Drug LabelingDo not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery ■ 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. ■ in children under 12 years of age
Ask a Doctor
openFDA Drug LabelingAsk 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
openFDA Drug LabelingStop 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.
Active Ingredient
openFDA Drug LabelingActive ingredients (in each extended-release tablet) Dextromethorphan HBr 30 mg Guaifenesin 600 mg Naproxen sodium 110 mg (naproxen 100 mg) (NSAID*) *nonsteroidal anti-inflammatory drug
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Guaifenesin Extended-Release Bi-Layer Tablets 600 mg NDC 63629-7115-1: 30 Tablets in a Bottle NDC 63629-7115-2: 20 Tablets in a Bottle NDC 63629-7115-3: 60 Tablets in a Bottle NDC 63629-7115-4: 40 Tablets in a Bottle NDC 63629-7115-5: 14 Tablets in a Bottle Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
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 |
|---|---|---|---|---|
| 50090-0818-0 | 50090-0818 | A-S Medication Solutions | 2 BLISTER PACK in 1 CARTON (50090-0818-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 28, 2014 |
| 50090-1340-0 | 50090-1340 | A-S Medication Solutions | 1 BLISTER PACK in 1 CARTON (50090-1340-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 28, 2014 |
| 50090-2301-1 | 50090-2301 | A-S Medication Solutions | 2 BLISTER PACK in 1 CARTON (50090-2301-1) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 5, 2025 |
| 50090-2380-0 | 50090-2380 | A-S Medication Solutions | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-2380-0) | April 27, 2016 |
| 50090-6078-0 | 50090-6078 | A-S Medication Solutions | 480 TABLET, EXTENDED RELEASE in 1 CASE (50090-6078-0) | September 16, 2022 |
| 17856-0008-2 | 17856-0008 | ATLANTIC BIOLOGICAS CORP. | 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (17856-0008-2) | June 5, 2024 |
| 68084-572-01 | 68084-572 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-572-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-572-11) | February 19, 2016 |
| 67544-149-53 | 67544-149 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-53) | July 9, 2012 |
| 67544-149-70 | 67544-149 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-70) | August 22, 2012 |
| 67544-149-80 | 67544-149 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-80) | July 12, 2012 |
| 63629-7115-1 | 63629-7115 | Bryant Ranch Prepack | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-1) | April 2, 2024 |
| 63629-7115-2 | 63629-7115 | Bryant Ranch Prepack | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-2) | October 17, 2016 |
| 63629-7115-3 | 63629-7115 | Bryant Ranch Prepack | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-3) | April 2, 2024 |
| 63629-7115-4 | 63629-7115 | Bryant Ranch Prepack | 40 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-4) | February 4, 2019 |
| 63629-7115-5 | 63629-7115 | Bryant Ranch Prepack | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-5) | April 2, 2024 |
| 63629-7115-6 | 63629-7115 | Bryant Ranch Prepack | 6 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-6) | April 2, 2024 |
| 63629-7115-7 | 63629-7115 | Bryant Ranch Prepack | 10 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-7) | April 2, 2024 |
| 63629-7886-1 | 63629-7886 | Bryant Ranch Prepack | 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (63629-7886-1) | June 13, 2019 |
| 63629-7886-2 | 63629-7886 | Bryant Ranch Prepack | 40 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (63629-7886-2) | April 3, 2024 |
| 55154-4680-0 | 55154-4680 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-4680-0) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | January 1, 2016 |
| 63187-954-20 | 63187-954 | Proficient Rx LP | 20 TABLET, EXTENDED RELEASE in 1 CARTON (63187-954-20) | August 1, 2019 |
| 63187-954-40 | 63187-954 | Proficient Rx LP | 40 TABLET, EXTENDED RELEASE in 1 CARTON (63187-954-40) | January 1, 2018 |
| 63824-008-15 | 63824-008 | Reckitt Benckiser LLC | 5 BLISTER PACK in 1 CARTON (63824-008-15) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2012 |
| 63824-008-27 | 63824-008 | Reckitt Benckiser LLC | 4 BLISTER PACK in 1 CARTON (63824-008-27) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2012 |
| 63824-008-32 | 63824-008 | Reckitt Benckiser LLC | 1 BLISTER PACK in 1 CARTON (63824-008-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2012 |
| 63824-008-34 | 63824-008 | Reckitt Benckiser LLC | 2 BLISTER PACK in 1 CARTON (63824-008-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2012 |
| 63824-008-36 | 63824-008 | Reckitt Benckiser LLC | 1 BLISTER PACK in 1 CARTON (63824-008-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2012 |
| 63824-008-50 | 63824-008 | Reckitt Benckiser LLC | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-008-50) | July 3, 2012 |
| 63824-008-69 | 63824-008 | Reckitt Benckiser LLC | 3 BLISTER PACK in 1 CARTON (63824-008-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2012 |
| 63824-008-72 | 63824-008 | Reckitt Benckiser LLC | 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-72) | July 3, 2012 |
| 63824-008-74 | 63824-008 | Reckitt Benckiser LLC | 24 POUCH in 1 CARTON (63824-008-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-73) | July 3, 2012 |
| 63824-008-80 | 63824-008 | Reckitt Benckiser LLC | 4 BLISTER PACK in 1 CARTON (63824-008-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2012 |
| 63824-008-86 | 63824-008 | Reckitt Benckiser LLC | 4 BLISTER PACK in 1 CARTON (63824-008-86) / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2012 |
| 63824-008-92 | 63824-008 | Reckitt Benckiser LLC | 6 BLISTER PACK in 1 CARTON (63824-008-92) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2012 |
| 63824-023-02 | 63824-023 | Reckitt Benckiser LLC | 1 POUCH in 1 CARTON (63824-023-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCH | July 1, 2021 |
| 63824-023-07 | 63824-023 | Reckitt Benckiser LLC | 1 BLISTER PACK in 1 CARTON (63824-023-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 11, 2015 |
| 63824-023-35 | 63824-023 | Reckitt Benckiser LLC | 1 BLISTER PACK in 1 CARTON (63824-023-35) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 26, 2012 |
| 63824-023-36 | 63824-023 | Reckitt Benckiser LLC | 2 BLISTER PACK in 1 CARTON (63824-023-36) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 26, 2012 |
| 63824-023-46 | 63824-023 | Reckitt Benckiser LLC | 3 BLISTER PACK in 1 CARTON (63824-023-46) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 26, 2012 |
| 63824-023-48 | 63824-023 | Reckitt Benckiser LLC | 4 BLISTER PACK in 1 CARTON (63824-023-48) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 26, 2012 |
| 63824-023-56 | 63824-023 | Reckitt Benckiser LLC | 4 BLISTER PACK in 1 CARTON (63824-023-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2021 |
| 72854-001-16 | 72854-001 | Reckitt Benckiser LLC | 2 BLISTER PACK in 1 CARTON (72854-001-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 1, 2026 |
| 72854-001-32 | 72854-001 | Reckitt Benckiser LLC | 4 BLISTER PACK in 1 CARTON (72854-001-32) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 1, 2026 |
| 72854-001-50 | 72854-001 | Reckitt Benckiser LLC | 5 BLISTER PACK in 1 CARTON (72854-001-50) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 1, 2026 |
| 72854-223-20 | 72854-223 | Reckitt Benckiser LLC | 2 BLISTER PACK in 1 CARTON (72854-223-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2026 |
| 50090-0818 | 50090-0818 | A-S Medication Solutions | — | July 3, 2012 |
| 50090-1340 | 50090-1340 | A-S Medication Solutions | — | July 3, 2012 |
| 50090-2301 | 50090-2301 | A-S Medication Solutions | — | June 26, 2012 |
| 50090-2380 | 50090-2380 | A-S Medication Solutions | — | July 3, 2012 |
| 50090-6078 | 50090-6078 | A-S Medication Solutions | — | July 3, 2012 |
| 17856-0008 | 17856-0008 | ATLANTIC BIOLOGICAS CORP. | — | July 3, 2012 |
| 68084-572 | 68084-572 | American Health Packaging | — | February 19, 2016 |
| 67544-149 | 67544-149 | Aphena Pharma Solutions - Tennessee, LLC | — | July 3, 2012 |
| 63629-7115 | 63629-7115 | Bryant Ranch Prepack | — | July 3, 2012 |
| 63629-7886 | 63629-7886 | Bryant Ranch Prepack | — | July 3, 2012 |
| 55154-4680 | 55154-4680 | Cardinal Health 107, LLC | — | January 1, 2016 |
| 63187-954 | 63187-954 | Proficient Rx LP | — | July 3, 2012 |
| 63824-008 | 63824-008 | Reckitt Benckiser LLC | — | July 3, 2012 |
| 63824-023 | 63824-023 | Reckitt Benckiser LLC | — | June 26, 2012 |
| 72854-001 | 72854-001 | Reckitt Benckiser LLC | — | June 1, 2026 |
| 72854-223 | 72854-223 | Reckitt Benckiser LLC | — | July 1, 2026 |
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.