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Mucinex

Guaifenesin · Tablet, Extended Release

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Mucinex
Generic name
Guaifenesin
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
A-S Medication Solutions
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
16
Packages
45
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the 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 Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
61

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
021282
Application type
NDA · New Drug Application
Approval date
July 12, 2002
Sponsor
RECKITT BENCKISER
Products on application
2
Submissions recorded
19
Products approved under application 021282.
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 Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes 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
Most recent submissions on application 021282.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20260629 HUMAN OTC DRUG · 20260602 HUMAN OTC DRUG · 20260527 HUMAN OTC DRUG · 20260512

Indications and Usage

openFDA Drug Labeling

Uses ■ 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

Purposes (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 Labeling

Directions 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 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 ■ 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 Labeling

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.

Active Ingredient

openFDA Drug Labeling

Active 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 Labeling

HOW 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 FAERS
202,963
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.