FDA.reportPublic FDA data

Maximum Strength Mucinex Fast-Max Day Time Cold and Flu

Manufacturer
RB Health (US) LLC
Effective date
2019-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:08

Label at a glance#

ProductMaximum Strength Mucinex Fast-Max Day Time Cold and Flu and Night Time Cold and Flu
Active ingredientAcetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride
Label structure10 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: cough minor aches and pains headache nasal congestion sore throat sinus congestion and pressure runny nose (NIGHT TIME only) sneezing (NIGHT TIME only) itching of the nose or throat (NIGHT TIME only) itchy, watery eyes due to hay fever (NIGHT TIME only) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome m...

Dosage and administration

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

Storage and handling

store between 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purposes
Mucinex FAST-MAX DAY TIME COLD & FLU
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each caplet)Purposes
Mucinex FAST-MAX NIGHT TIME COLD & FLU
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • minor aches and pains
    • headache
    • nasal congestion
    • sore throat
    • sinus congestion and pressure
    • runny nose (NIGHT TIME only)
    • sneezing (NIGHT TIME only)
    • itching of the nose or throat (NIGHT TIME only)
    • itchy, watery eyes due to hay fever (NIGHT TIME only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
  • controls cough to help you get to sleep
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on the skin (NIGHT TIME only)
  • 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

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (NIGHT TIME only)
  • a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME only)
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (NIGHT TIME only)

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children (NIGHT TIME only)
  • marked drowsiness may occur (NIGHT TIME only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME only)
  • avoid alcoholic drinks (NIGHT TIME only)
  • be careful when driving a motor vehicle or operating machinery (NIGHT TIME only)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

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.

Overdose warning

SPL UNCLASSIFIED SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

(Mucinex FAST-MAX DAY TIME COLD & FLU)

croscarmellose sodium, crospovidone, 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

(Mucinex FAST-MAX NIGHT TIME COLD & FLU)

croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, titanium dioxide

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
NDC 63824-511-30

Mucinex®
FAST-MAX ®

DAY
TIME
COLD & FLU

Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

HEADACHE
BODY PAIN
SORE THROAT
FEVER
CHEST CONGESTION
COUGH
ALL IN
ONE*
NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE

20 CAPLETS

FOR AGES 12+

NIGHT
TIME
COLD & FLU

Acetaminophen - Pain Reliever/Fever Reducer
Diphenhydramine HCl - Antihistamine/
Cough Suppressant
Phenylephrine HCl - Nasal Decongestant

HEADACHE
BODY PAIN
SORE THROAT
FEVER
ITCHY THROAT
COUGH
ALL IN
ONE*
NASAL CONGESTION
SNEEZING
RUNNY NOSE

10 CAPLETS

FOR AGES 12+

TOTAL 30 CAPLETS

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN2
1233575acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletPSN2
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2
1233575acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2
1233575acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletSY2
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY2
1233575APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-511-302021-01-29C16284748780-1ba0f9c33-3f15-a910-e053-dadaa90a0b85Maximum Strength Mucinex® Fast-Max ® Day Time Cold & Flu and Night Time Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-511-30Maximum Strength Mucinex Fast-Max Day Time Cold and Flu and Night Time Cold and Flu1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-511MAXIMUM STRENGTH MUCINEX FAST-MAX DAY TIME COLD AND FLU AND NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]2Legacy NDC, 1 package rows20191219_bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-511-20EA - Each63824-511069a828f-8245-4d5b-a60e-02087618584612021-01-08
63824-511-30EA - Each63824-511835bd8fa-edac-4a39-a047-e4170d7b8f4312020-04-20
63824-511-40EA - Each63824-511942eae50-9927-42aa-bff5-64ebc6ac02b412021-04-08

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
63824-51163824-511-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
Guaifenesin495W7451VQACTIB
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
croscarmellose sodiumM28OL1HH48IACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
FD&C red no. 40WZB9127XOAIACT
FD&C yellow no. 6H77VEI93A8IACT
ALUMINUM OXIDELMI26O6933IACT
Magnesium stearate70097M6I30IACT
microcrystalline celluloseOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
talc7SEV7J4R1UIACT
titanium dioxide15FIX9V2JPIACT
Acetaminophen362O9ITL9DACTIB
Diphenhydramine HydrochlorideTC2D6JAD40ACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
croscarmellose sodiumM28OL1HH48IACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
FD&C blue no. 1H3R47K3TBDIACT
FD&C blue no. 2L06K8R7DQKIACT
ALUMINUM OXIDELMI26O6933IACT
ferric oxide yellowEX438O2MRTIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
micaV8A1AW0880IACT
microcrystalline celluloseOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
sodium bicarbonate8MDF5V39QOIACT
talc7SEV7J4R1UIACT
titanium dioxide15FIX9V2JPIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f46ce111-392c-41c4-8356-c74b9b5b9edabc823ebb-a4c6-4467-a1e7-f3333e4fd5d32019-12-17WarningsExact identifier
spl id: f46ce111-392c-41c4-8356-c74b9b5b9eda
spl set id: bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3

Reported adverse events (FAERS/openFDA)#

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