FDA.reportPublic FDA data

Mucinex Fast-Max Day Time Severe Congestion and Cough Maximum Strength

Manufacturer
RB Health (US) LLC
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:17:11

Label at a glance#

ProductMucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength
Active ingredientDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Acetaminophen, Diphenhydramine Hydrochloride
Label structure12 sections

Indications and uses

temporarily relieves (DAY TIME only) : 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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only) temporaril...

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 older: 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)
Mucinex FAST-MAX DAY TIME Severe Congestion & Cough		Purposes
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)
Mucinex FAST-MAX NIGHT TIME Cold & Flu		Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning (NIGHT TIME only)

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 that contain acetaminophen
  • 3 or more alcoholic drinks daily while using this product

SPL UNCLASSIFIED SECTION

Sore throat warning (NIGHT TIME only): 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. (NIGHT TIME only)
  • with any other drug 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.
  • for children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease (NIGHT TIME only)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 (DAY TIME only)
  • cough that occurs with too much phlegm (mucus) (DAY TIME only)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not use more than directed. In addition, for NIGHT TIME only:

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

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 a fever (DAY TIME only)
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days (NIGHT TIME only)
  • fever gets worse, or lasts more than 3 days (NIGHT TIME only)
  • redness or swelling is present (NIGHT TIME only)
  • new symptoms occur (NIGHT TIME only)
  • 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.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. (NIGHT TIME only)

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 older: 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 (Mucinex FAST-MAX DAY TIME Severe Congestion & Cough)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C Blue #2 aluminum lake, FD&C Red #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

Inactive ingredients (Mucinex FAST-MAX NIGHT TIME Cold & Flu)

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, crospovidone, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

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: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH*

NDC 63824-555-30

Mucinex®
FAST-MAX ®

DAY
TIME

Severe Congestion
& Cough

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

✓ Controls Cough
✓ Relieves Nasal &
Chest Congestion
✓ Thins & Loosens Mucus

AGES 12+

20 CAPLETS

NIGHT
TIME
Cold & Flu

Acetaminophen • Pain Reliever/Fever Reducer
Diphenhydramine HCl • Antihistamine
Phenylephrine HCl • Nasal Decongestant

✓ Relieves Aches,
Fever & Sore Throat
✓ Relieves Nasal Congestion
✓ Relieves Runny Nose
& Sneezing

10 CAPLETS

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-555-30EA - Each63824-55589d84a61-1c13-47dd-af20-b1faf2a6b9b412015-07-20
63824-193-20EA - Each63824-193ce7e2c2e-b0c4-44d2-9cf8-7f3b1991e1c312013-11-04
63824-193-30EA - Each63824-193f55e9eef-3a6b-42c7-9cfe-b7dd61da2d6212014-04-03
63824-550-20EA - Each63824-550bcddd54b-f72d-4eb7-ae4d-778fcaa60ed012013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH1
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD401
GuaifenesinACTIVE INGREDIENT495W7451VQ1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
DextromethorphanACTIVE MOIETY7355X3ROTS1
DiphenhydramineACTIVE MOIETY8GTS82S83M1
GuaifenesinACTIVE MOIETY495W7451VQ1
PhenylephrineACTIVE MOIETY1WS297W6MV1
aluminum oxideINACTIVE INGREDIENTLMI26O69331
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH481
crospovidoneINACTIVE INGREDIENT68401960MK1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQK1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA1
hypromellosesINACTIVE INGREDIENT3NXW29V3WO1
magnesium stearateINACTIVE INGREDIENT70097M6I301
micaINACTIVE INGREDIENTV8A1AW08801
polydextroseINACTIVE INGREDIENTVH2XOU12IE1
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5P1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H1
polyvinyl alcoholINACTIVE INGREDIENT532B59J9901
povidone K29/32INACTIVE INGREDIENT390RMW2PEQ1
povidonesINACTIVE INGREDIENTFZ989GH94E1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QO1
starch, cornINACTIVE INGREDIENTO8232NY3SJ1
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
talcINACTIVE INGREDIENT7SEV7J4R1U1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
triacetinINACTIVE INGREDIENTXHX3C3X6731

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-55563824-555-30
63824-193
63824-550

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
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
Guaifenesin495W7451VQACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
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
talc7SEV7J4R1UIACT
titanium dioxide15FIX9V2JPIACT
Acetaminophen362O9ITL9DACTIB
Diphenhydramine HydrochlorideTC2D6JAD40ACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
starch, cornO8232NY3SJIACT
croscarmellose sodiumM28OL1HH48IACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
FD&C Blue No. 1H3R47K3TBDIACT
aluminum oxideLMI26O6933IACT
hypromellose, unspecified3NXW29V3WOIACT
magnesium stearate70097M6I30IACT
microcrystalline celluloseOP1R32D61UIACT
polydextroseVH2XOU12IEIACT
polyethylene glycol, unspecified3WJQ0SDW1AIACT
povidone, unspecifiedFZ989GH94EIACT
silicon dioxideETJ7Z6XBU4IACT
stearic acid4ELV7Z65APIACT
titanium dioxide15FIX9V2JPIACT
triacetinXHX3C3X673IACT

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C Blue No. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
triacetinTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
starch, cornSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii+route+dosage form
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii+route+dosage form
povidonesPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
stearic acidSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii+route+dosage form
polydextrosePOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route
3 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route+dosage form
polydextrosePOLYDEXTROSEVH2XOU12IETABLET, EXTENDED RELEASE / ORAL22 mgExact identifier — unii+route
3 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
polydextrosePOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route
3 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 · 2 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 (product): 63824-193
06c1d4d2-2b64-fb90-e063-6394a90ace3f815f0ec8-d89d-4e74-8328-5e3b30fbe3ec2023-10-02WarningsExact identifier
spl set id: 815f0ec8-d89d-4e74-8328-5e3b30fbe3ec

Reported adverse events (FAERS/openFDA)#

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