Mucinex 12HR Cold & Fever Multi-Symptom

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-06-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-04 05:10:12

Label at a glance#

ProductMucinex 12HR Cold and Fever Multi-Symptom
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, NAPROXEN SODIUM, GUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Active ingredients (in each extended-release tablet) >> Purposes

Dextromethorphan HBr 30 mg >> Cough Suppressant

Guaifenesin 600 mg >> Expectorant

Naproxen Sodium 110 mg (NSAID*) >> Pain Reliever/Fever Reducer

*nonsteroidal anti-inflammatory drug

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a
Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
■ do not crush, chew, or break extended-release tablet
■ do not take more than directed
■ take each dose with a full glass of water
■ adults and children 12 years and older: take 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

OTHER SAFETY INFORMATION

Other information
■ each extended-release tablet contains: sodium 26 mg
■ store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients:

croscarmellose sodium, FD&C red no. 40, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium bicarbonate, sodium lauryl sulfate

OTC - QUESTIONS SECTION

Questions? 1-866-MUCINEX (1-866-682-4639)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72854-001-16

Mucinex®

12HR COLD & FEVER

MULTI-SYMPTOM

Naproxen Sodium 110 mg (NSAID) >> Pain Reliever/Fever Reducer

Dextromethorphan HBr 30 mg >> Cough Suppressant

Guaifenesin 600 mg >> Expectorant

Extended-Release Tablets

12 HOUR

Fever, Headache & Body Pain
Cough + Chest Congestion
Thins & Loosens Mucus

16 EXTENDED-RELEASE TABLET

full carton labelfull carton label

back labelback label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.mucinex.com/pages/product-faqs72854-001 front label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-00172854-001-16, 72854-001-32, 72854-001-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-03daily-update2026-06-03 18:04:09

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217338-001112785062036-10-11Drug product2026-04-07
N217338-001122572182036-10-11Drug product2026-04-07
N217338-001123701892036-10-11Drug product2026-04-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22c2088c7a36db…
2026-09-14 22:38:342026-08N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-2284e616aacf4f…
2026-08-18 06:07:402026-07N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N217338-001112785062036-10-11Drug product2026-04-07c2088c7a36db…
2026-10-15 13:18:302026-09N217338-001122572182036-10-11Drug product2026-04-07c2088c7a36db…
2026-10-15 13:18:302026-09N217338-001123701892036-10-11Drug product2026-04-07c2088c7a36db…
2026-09-14 22:38:342026-08N217338-001112785062036-10-11Drug product2026-04-0784e616aacf4f…
2026-09-14 22:38:342026-08N217338-001122572182036-10-11Drug product2026-04-0784e616aacf4f…
2026-09-14 22:38:342026-08N217338-001123701892036-10-11Drug product2026-04-0784e616aacf4f…
2026-08-18 06:07:402026-07N217338-001112785062036-10-11Drug product2026-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217338-001122572182036-10-11Drug product2026-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217338-001123701892036-10-11Drug product2026-04-07caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001112785062036-10-11Drug product2026-04-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001122572182036-10-11Drug product2026-04-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001123701892036-10-11Drug product2026-04-07a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex 12HR Cold and Fever Multi-SymptomNAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC49f1f415-8017-0974-e063-6294a90a89182026-06-02WarningsExact identifier
ndc (package): 72854-001-32
ndc (package): 72854-001-50
ndc (package): 72854-001-16
ndc (product): 72854-001
ndc11 (package): 72854000116
ndc11 (package): 72854000150
ndc11 (package): 72854000132
spl id: 53490589-6b93-42b2-e063-6394a90a3c02
spl set id: 49f1f415-8017-0974-e063-6294a90a8918

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.