Mucinex® Fast-Max® Cold & Flu
- Manufacturer
- Reckitt Benckiser LLC
- Effective date
- 2026-10-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-10-22 02:02:14
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 caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
OTC - PURPOSE SECTION
Purposes
Acetaminophen 325 mg..............Pain reliever/fever reducer
Dextromethorphan HBr 10 mg....Cough suppressant
INDICATIONS & USAGE SECTION
Uses
■ temporarily relieves these common cold and flu
symptoms:
■ 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
■ sore throat
■ headache
■ temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
■ more than 12 caplets in 24 hours, which is the
maximum daily amount for this product
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks daily while using this
product
Allergy alert: Acetaminophen may cause severe
skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek
medical help right away.
Sore throat warning: If sore throat is severe,
persists for more than 2 days, is accompanied or
followed by fever, headache, rash, nausea, or
vomiting, consult a doctor promptly.
Do not use
■ with any other drug containing acetaminophen
(prescription or nonprescription). If you are not
sure whether a drug contains acetaminophen,
ask a doctor or pharmacist.
■ 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
■ liver disease
■ persistent or chronic cough such as occurs with
smoking, asthma, or emphysema
■ cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
When using this product do not use more than
directed
Stop use and ask a doctor if
■ pain or cough gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
■ cough comes back or occurs with rash or headache
that lasts. These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
SPL UNCLASSIFIED SECTION
Overdose warning: Taking more than the
recommended dose (overdose) may cause liver
damage. In case of overdose, get medical help or
contact a Poison Control Center right away. Quick
medical attention is critical for adults as well as for
children even if you do not notice any signs or
symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
■
do not take more than directed (see Overdose
warning)
■ do not take more than 12 caplets in any 24-hour
period
■ adults and children 12 years of age and over:
take 2 caplets every 4 hours
■ children under 12 years of age: do not use
OTHER SAFETY INFORMATION
Other information
■ store at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
croscarmellose sodium, FD&C red no. 40 aluminum
lake, FD&C yellow no. 6 aluminum lake,
microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol, povidone, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions? 1-866-MUCINEX (1-866-682-4639)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code | 72854-161 label.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Mucinex Fast-Max Cold and Flu
- Acetaminophen, Dextromethorphan Hydrobromide
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- FD&C YELLOW NO. 6 ALUMINUM LAKE
- TITANIUM DIOXIDE
- FD&C RED NO. 40 ALUMINUM LAKE
- TALC
- POLYVINYL ALCOHOL
- POVIDONE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- CROSCARMELLOSE SODIUM
- MICROCRYSTALLINE CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72854-161 | 72854-161-10, 72854-161-20, 72854-161-02, 72854-161-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-05-19 | full-release | 2026-06-01 01:58:03 |
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 |
|---|---|---|---|---|---|---|
| 522dbf72-6c3c-de6a-e063-6394a90ac6ec | 31ac6883-ffcd-39de-e063-6294a90a52dd | 2026-05-19 | Warnings | 31ac6883-ffcd-39de-e063-6294a90a52dd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
