Mucinex Fast-Max Kickstart Severe Cold & Flu and Night Time Cold & Flu

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:58:17

Label at a glance#

ProductMUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN, TRIPROLIDINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

KICKSTART SEVERE COLD & FLU: temporarily relieves these common cold and flu symptoms: ■ cough ■ nasal congestion ■ minor aches and pains ■ sore throat ■ headache ■ stuffy nose ■ sinus congestion and pressure ■ temporarily reduces fever ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive NIGHT TIME SEVERE COLD & FLU: tempor...

Dosage and administration

KICKSTART SEVERE COLD & FLU ■ do not take more than directed (see Overdose warning) ■ do not take more than 6 doses in any 24-hour period ■ measure only with dosing cup provided ■ do not use dosing cup with other products ■ dose as follows or as directed by a doctor ■ adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours ■ children under 12 years of age: do not use NIGHT TIME SEV...

Storage and handling

KICKSTART SEVERE COLD & FLU ■ each 20 mL contains: sodium 12 mg ■ store at 20-25°C (68-77°F) ■ do not refrigerate NIGHT TIME SEVERE COLD & FLU ■ each 20 mL contains: sodium 16 mg ■ store at 20-25°C (68-77°F) ■ do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

KICKSTART SEVERE COLD & FLU:

Acetaminophen 650mg.................................Pain reliever/fever reducer
Dextromethorphan HBr 20 mg.....................................Cough suppressant
Guaifenesin 400 mg........................................................Expectorant
Phenylephrine HCl 10mg........................................Nasal decongestant

NIGHT TIME SEVERE COLD & FLU:

Acetaminophen 650mg............................ ....Pain reliever/fever reducer
Dextromethorphan HBr 20 mg....................................Cough suppressant
Phenylephrine HCl 10mg................................... . . . .Nasal decongestant
Triprolidine HCl 2.5 mg................................................Antihistamine

Uses

INDICATIONS & USAGE SECTION

KICKSTART SEVERE COLD & FLU:

temporarily relieves these common cold and flu symptoms:

■ cough

■ nasal congestion

■ minor aches and pains

■ sore throat
■ headache

■ stuffy nose

■ sinus congestion and pressure
■ temporarily reduces fever
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial
passageways of bothersome mucus and make coughs more productive

NIGHT TIME SEVERE COLD & FLU:

temporarily relieves these common cold and flu symptoms:

■ cough

■ nasal congestion

■ minor aches and pains

■ sore throat
■ headache

■ sinus congestion and pressure

■ 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

WARNINGS SECTION

KICKSTART SEVERE COLD & FLU:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if
you take:
■ more than 6 doses in 24 hours, which is the maximum daily amount
■ 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

■ heart disease
■ diabetes

■ high blood pressure

■ thyroid disease
■ trouble urinating due to an enlarged prostate gland
■ 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
■ nervousness, dizziness, or sleeplessness occur
■ pain, nasal congestion, 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 fever, rash, or headache that lasts. These could
be signs of a serious condition.

NIGHT TIME SEVERE COLD & FLU:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if
you take:
■ more than 4,000 mg in 24 hours, which is the maximum daily amount
■ 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

■ heart disease
■ diabetes

■ high blood pressure

■ thyroid 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


Stop use and ask a doctor if
■ nervousness, dizziness, or sleeplessness occur
■ pain, nasal congestion, 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 fever,
rash, or headache that lasts

.

These could be signs of a serious condition.

Directions

DOSAGE & ADMINISTRATION SECTION

KICKSTART SEVERE COLD & FLU

■ do not take more than directed (see
Overdose warning)
■ do not take more than 6 doses in any
24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and
over: 20 mL in dosing cup provided
every 4 hours
■ children under 12 years of age: do not use

NIGHT TIME SEVERE COLD & FLU

■ do not take more than directed (see
Overdose warning)
■ do not take more than 4 doses in any
24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and
over: 20 mL in dosing cup provided
every 4 hours
■ children under 12 years of age: do not use

Other Information

STORAGE AND HANDLING SECTION

KICKSTART SEVERE COLD & FLU

■ each 20 mL contains: sodium 12 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

NIGHT TIME SEVERE COLD & FLU

■ each 20 mL contains: sodium 16 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

INACTIVE INGREDIENT SECTION

KICKSTART SEVERE COLD & FLU

ammonium glycyrrhizate, anhydrous citric acid, D&C
yellow no. 10, edetate disodium, FD&C blue
no. 1, flavors, glycerin, propylene glycol,
purified water, sodium benzoate, sodium
citrate, sorbitol, sucralose, xanthan gum

NIGHT TIME SEVERE COLD & FLU

ammonium glycyrrhizate, anhydrous citric acid, ascorbic
acid, edetate disodium, FD&C blue no. 1,
FD&C red no. 40, flavors, glycerin (soy),
propylene glycol, sodium benzoate, sorbitol,
sucralose, triacetin, triethyl citrate, water,
xanthan gum

OTC - QUESTIONS SECTION

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

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.

Purposes

OTC - PURPOSE SECTION

KICKSTART SEVERE COLD & FLU:

Dextromethorphan HBr 20 mg.....................................Cough suppressant
Guaifenesin 400 mg........................................................Expectorant
Phenylephrine HCl 10mg........................................Nasal decongestant

NIGHT TIME SEVERE COLD & FLU:

Dextromethorphan HBr 20 mg....................................Cough suppressant
Phenylephrine HCl 10mg................................... . . . .Nasal decongestant
Triprolidine HCl 2.5 mg................................................Antihistamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back labelback labelLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2637727{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) } PackGPCK3
26377271 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG in 10 mL Oral Solution) PackPSN3
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN3
2173662acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN3
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD3
2173662acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD3
26377271 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG per 10 ML Oral Solution) PackSY3
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY3
2173662acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral SolutionSY3
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY3
2173662acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY3
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY3
2173662APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-138-66MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart180 mL in 1 BOTTLESOLUTION180 mL650 mg in 20mL3
72854-139-26MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart1 in 1 CARTONKIT13
72854-140-66MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart180 mL in 1 BOTTLESOLUTION180 mL10 mg in 20mL3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-139-26ML - Milliliter72854-1398d1680e6-4d7b-444d-9662-cfbda96ce95712024-08-12
72854-138-66ML - Milliliter72854-13812a5d25f-5889-428e-9341-9b72ca0ba5b212024-03-12

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-13972854-139-26
72854-13872854-138-66
72854-14072854-140-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift KickstartACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCIReckitt Benckiser LLCfdb70793-5dd1-0455-e053-6394a90ac6212026-05-19WarningsExact identifier
ndc (package): 72854-139-26
ndc (package): 72854-138-66
ndc (package): 72854-140-66
ndc (product): 72854-139
ndc11 (package): 72854013866
ndc11 (package): 72854014066
ndc11 (package): 72854013926
spl id: 522d77b2-7e4f-6d39-e063-6294a90ac951
spl set id: fdb70793-5dd1-0455-e053-6394a90ac621
Mucinex Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCfdb5c937-c148-eb46-e053-6394a90a8bed2026-05-13WarningsExact identifier
ndc (package): 72854-140-66
ndc (product): 72854-140
ndc11 (package): 72854014066
Mucinex Fast-Max Kickstart Severe Cold and Flu and Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, AND TRIPROLIDINE HCLRB Health (US) LLC4cc490a6-a27a-a25b-e063-6294a90a3a952026-03-11WarningsExact identifier
ndc (package): 72854-138-66
ndc11 (package): 72854013866

Reported adverse events (FAERS/openFDA)#

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