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#
Contacts and useful links#
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
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code | 72854-001 front label.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Mucinex 12HR Cold and Fever Multi-Symptom
- Naproxen Sodium, Dextromethorphan Hydrobromide, Guaifenesin
- SODIUM BICARBONATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- NAPROXEN SODIUM
- NAPROXEN
- MICROCRYSTALLINE CELLULOSE
- FD&C RED NO. 40
- HYDROXYETHYL CELLULOSE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- GUAIFENESIN
- CROSCARMELLOSE SODIUM
- SODIUM LAURYL SULFATE
- MAGNESIUM STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72854-001 | 72854-001-16, 72854-001-32, 72854-001-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-02-03 | daily-update | 2026-06-03 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 products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | |
| N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | |
| N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mucinex 12HR Cold and Fever Multi-Symptom | NAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 49f1f415-8017-0974-e063-6294a90a8918 | 2026-06-02 | Warnings | 72854-001-32 72854-001-50 72854-001-16 72854-001 72854000116 72854000150 72854000132 53490589-6b93-42b2-e063-6394a90a3c02 49f1f415-8017-0974-e063-6294a90a8918 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

