FDA.reportPublic FDA data

Mucinex® Fast-Max

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:57:10

Label at a glance#

ProductMucinex Fast-Max Severe Congestion and Cough
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: 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 nasal congestion due to a cold

Dosage and administration

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 at 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
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • 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
    • nasal congestion due to a cold

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

  • 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)

OTC - WHEN USING SECTION

When using this product do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, methacrylic acid-ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Principal Display Panel - 20 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
NDC 63824-193-21

Mucinex®
FAST-MAX ®

SEVERE CONGESTION
& COUGH

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

✓ Controls Cough

✓ Relieves Nasal & Chest Congestion

✓ Thins & Loosens Mucus

Actual Size

20 CAPLETS
FOR AGES 12+

Principal Display Panel - 20 Caplet Blister Pack Carton
Principal Display Panel - 20 Caplet Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372652dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN12
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD12
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral TabletSY12

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-193-20Mucinex Fast-MaxSevere Congestion and Cough10 in 1 BLISTER PACKTABLET, COATED1012
63824-193-20Mucinex Fast-MaxSevere Congestion and Cough2 in 1 CARTONTABLET, COATED212
63824-193-21Mucinex Fast-MaxSevere Congestion and Cough2 in 1 CARTONTABLET, COATED212
63824-193-21Mucinex Fast-MaxSevere Congestion and Cough10 in 1 BLISTER PACKTABLET, COATED1012
63824-193-30Mucinex Fast-MaxSevere Congestion and Cough3 in 1 CARTONTABLET, COATED312
63824-193-30Mucinex Fast-MaxSevere Congestion and Cough10 in 1 BLISTER PACKTABLET, COATED1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-193-20EA - Each63824-193ce7e2c2e-b0c4-44d2-9cf8-7f3b1991e1c312013-11-04
63824-193-30EA - Each63824-193f55e9eef-3a6b-42c7-9cfe-b7dd61da2d6212014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYH5
GuaifenesinACTIVE INGREDIENT495W7451VQ5
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ5
DextromethorphanACTIVE MOIETY7355X3ROTS5
GuaifenesinACTIVE MOIETY495W7451VQ5
PhenylephrineACTIVE MOIETY1WS297W6MV5
aluminum oxideINACTIVE INGREDIENTLMI26O69335
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH485
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQK5
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOA5
micaINACTIVE INGREDIENTV8A1AW08805
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5P5
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H5
polyvinyl alcoholINACTIVE INGREDIENT532B59J9905
povidone K29/32INACTIVE INGREDIENT390RMW2PEQ5
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QO5
talcINACTIVE INGREDIENT7SEV7J4R1U5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP5

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-19363824-193-20, 63824-193-30, 63824-193-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C RED NO. 40WZB9127XOAIACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE K30U725QWY32XIACT
SODIUM BICARBONATE8MDF5V39QOIACT
GUAIFENESIN495W7451VQACTIB
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 44 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C red no. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
4 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C blue no. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C blue no. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C blue no. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
4 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
4 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
4 equally ranked IID candidates
FD&C blue no. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC3ff4c4ea-7628-4d2b-a6e9-d994c25baef42026-05-12WarningsExact identifier
ndc (package): 63824-193-30
ndc (package): 63824-193-20
ndc (package): 63824-193-21
ndc (product): 63824-193
ndc11 (package): 63824019321
ndc11 (package): 63824019320
ndc11 (package): 63824019330
spl id: 51a49920-1f2b-2b23-e063-6294a90ace67
spl set id: 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4

Reported adverse events (FAERS/openFDA)#

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