MUCINEX® FAST-MAX® Liquid Gels - Day Night Cold & Flu

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-11 03:02:13

Label at a glance#

ProductMUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose Day:
Acetaminophen 325 mg...Pain reliever/fever reducer

Dextromethorphan HBr 10 mg.......Cough suppressant

Purpose Night:

Acetaminophen 325 mg...Pain reliever/fever reducer
Dextromethorphan HBr 10 mg.......Cough suppressant
Doxylamine succinate 6.25 mg............. Antihistamine

OTC - ACTIVE INGREDIENT SECTION

Day:

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Night:

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg

INDICATIONS & USAGE SECTION

Day:

■ 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

Night:

■ temporarily relieves these common cold and flu
symptoms:
■ cough ■ minor aches and pains
■ sore throat ■ headache ■ runny nose
■ sneezing
■ itching of the nose or throat
■ itchy, watery eyes due to hay fever
■ temporarily reduces fever
■ controls cough to help you get to sleep

WARNINGS SECTION

Day:


Liver warning: This product contains
acetaminophen. Severe liver damage may occur if
you take:
■ more than 12 capsules 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.

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.

Night:


Severe liver damage may occur if you take:
■ more than 12 capsules 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 ■ glaucoma
■ trouble urinating due to an enlarged prostate
gland
■ a breathing problem such as emphysema or
chronic bronchitis
■ 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
■ taking sedatives or tranquilizers


When using this product
■ do not use more than directed
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may
increase drowsiness
■ avoid alcoholic drinks
■ use caution when driving a motor vehicle or
operating machinery

DOSAGE & ADMINISTRATION SECTION

Day:


Directions
■ do not take more than directed (see Overdose
warning)
■ do not take more than 12 capsules in any 24-hour
period
■ adults and children 12 years of age and over: take 2
capsules every 4 hours
■ children under 12 years of age: do not use

Night:

Directions
■ do not take more than directed (see Overdose
warning)
■ do not take more than 12 capsules in any 24-hour
period
■ adults and children 12 years of age and over: take 2
capsules 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)
■ avoid excessive heat

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


If pregnant or breast-feeding, ask a health
professional before use.


Keep out of reach of children.


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.

INACTIVE INGREDIENT SECTION

Day:


FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin,
hypromellose, isopropyl alcohol, lecithin (sunflower),
light mineral oil, mannitol, polyethylene glycol 400,
povidone, propylene glycol, purified water, 1,4-sorbitan,
sorbitol, titanium dioxide

Night:


D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin,
hypromellose, isopropyl alcohol, lecithin (sunflower),
light mineral oil, mannitol, polyethylene glycol 400,
povidone, propylene glycol, purified water, 1,4-sorbitan,
sorbitol, titanium dioxide

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelcarton label

back labelback label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363824999029GTIN-13: 0363824999029
EAN-13: 0363824999029
GTIN-12: 363824999029
UPC-A: 363824999029
GTIN storage (14 digits): 00363824999029
72854-168 front label.jpg
Data codeData Matrix332157472854-168 back label.jpg

DailyMed Product Concepts#

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Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-16872854-168-10, 72854-168-24, 72854-168-48
72854-17172854-171-08
72854-003

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-05-18full-release2026-06-01 01:57:52
22026-04-01monthly-update2026-06-03 18:00:27

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
ndc (package): 72854-168-24
ndc (package): 72854-168-48
ndc (package): 72854-171-08
ndc (package): 72854-168-10
ndc (product): 72854-168
ndc11 (package): 72854016824
ndc11 (package): 72854016810
ndc11 (package): 72854016848
ndc11 (package): 72854017108
spl id: 5b106355-7a63-8c52-e063-6394a90a7659
spl set id: 3856c1e4-814f-85c4-e063-6394a90ab8a8
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
ndc (package): 72854-171-08
ndc (product): 72854-171
ndc11 (package): 72854017108

Reported adverse events (FAERS/openFDA)#

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