Acetaminophen, Guaifenesin - Reckitt Benckiser LLC
- Manufacturer
- Reckitt Benckiser LLC
- Effective date
- 2026-05-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:57:17
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
(in each caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
INDICATIONS & USAGE SECTION
Uses
■ temporarily relieves these common cold and flu
symptoms:
■ minor aches and pains ■ headache
■ sore throat
■ helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial
passageways of bothersome mucus and make
coughs more productive
■ 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.
Ask a doctor before use if you have
■ liver disease
■ persistent or chronic cough such as occurs
with smoking, asthma, chronic bronchitis, 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.
If pregnant or breast-feeding, ask a health
professional before use.
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, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polyvinyl
alcohol, povidone, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions? 1-866-MUCINEX
(1-866-682-4639)
OTC - PURPOSE SECTION
Acetaminophen 325 mg ........ Pain reliever/
fever reducer
Guaifenesin 200 mg.................... Expectorant
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code | 72854-208 label 1.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72854-208-02 | Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 2 | |
| 72854-208-08 | Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | 4 in 1 CARTON | TABLET, FILM COATED | 4 | 2 | |
| 72854-208-08 | Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 2 | |
| 72854-208-10 | Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 2 | |
| 72854-208-10 | Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 72854-208-20 | Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 2 | |
| 72854-208-20 | Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 2 |
Products#
Every source-derived product name is available through these pages.
- Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough
- Acetaminophen, Guaifenesin
- TITANIUM DIOXIDE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL
- GUAIFENESIN
- POVIDONE, UNSPECIFIED
- CROSCARMELLOSE SODIUM
- ACETAMINOPHEN
- MAGNESIUM STEARATE
- TALC
- FD&C RED NO. 40 ALUMINUM LAKE
- FD&C YELLOW NO. 6 ALUMINUM LAKE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72854-208 | 72854-208-10, 72854-208-20, 72854-208-02, 72854-208-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | 350764de-7801-b24e-e063-6394a90ab3c3 | 2026-05-13 | Warnings | 72854-208-02 72854-208-08 72854-208-20 72854-208-10 72854-208 72854020820 72854020802 72854020808 72854020810 51b4e933-f056-2a27-e063-6394a90a839f 350764de-7801-b24e-e063-6394a90ab3c3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
