FDA.reportPublic FDA data

Mucinex Fast-Max

Manufacturer
RB Health (US) LLC
Effective date
2019-10-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:00:46

Label at a glance#

ProductMucinex Fast-Max Congestion and Headache
Active ingredientAcetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
Label structure10 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: nasal congestion cough headache minor aches and pains sinus congestion and pressure temporarily reduces fever temporarily promotes nasal and/or sinus drainage

Dosage and administration

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

Storage and handling

store at 20-25°C (68-77°F) avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each liquid gel)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • headache
    • minor aches and pains
    • sinus congestion and pressure
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 liquid gels 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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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, or emphysema
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not use more than directed

OTC - STOP USE SECTION

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 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 liquid gels in any 24-hour period
  • adults and children 12 years of age and older: take 2 liquid gels 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)
  • avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, water

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
Made in China

PRINCIPAL DISPLAY PANEL - 16 Liquid Gel Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH
NDC 63824-599-16

Mucinex®
FAST-MAX®

CONGESTION &
HEADACHE

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant

  • Relieves Headache & Fever
  • Controls Cough
  • Relieves Nasal Congestion

16
LIQUID GELS
(Liquid Filled Capsules)
DAY TIME
FOR AGES 12+

PRINCIPAL DISPLAY PANEL - 16 Liquid Gel Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 16 Liquid Gel Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN4
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD4
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
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4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
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105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-599-162022-01-28C16284748780-1d6a99b39-84fe-a426-e053-dadaa90af4c2Mucinex® Fast-Max ® Congestion & Headache

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-599-16Mucinex Fast-Max Congestion and Headache2 in 1 CARTONCAPSULE, LIQUID FILLED24
63824-599-16Mucinex Fast-Max Congestion and Headache8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-599MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RB HEALTH (US) LLC]4Legacy NDC, 2 package rows20191010_3d59587e-8f28-40d5-9b1b-2aebd50a148f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-599-16EA - Each63824-5994824e138-9aaa-48f2-a727-d0600fcbe46e12017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
Dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYH1
Phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
DextromethorphanACTIVE MOIETY7355X3ROTS1
PhenylephrineACTIVE MOIETY1WS297W6MV1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOA1
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A81
gelatinINACTIVE INGREDIENT2G86QN327L1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
lecithin, soybeanINACTIVE INGREDIENT1DI56QDM621
mineral oilINACTIVE INGREDIENTT5L8T28FGP1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A1
povidonesINACTIVE INGREDIENTFZ989GH94E1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
sorbitolINACTIVE INGREDIENT506T60A25R1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
waterINACTIVE INGREDIENT059QF0KO0R1

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
63824-59963824-599-16

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
Acetaminophen362O9ITL9DACTIB
Dextromethorphan hydrobromide9D2RTI9KYHACTIB
Phenylephrine hydrochloride04JA59TNSJACTIB
FD&C red no. 40WZB9127XOAIACT
FD&C yellow no. 6H77VEI93A8IACT
gelatin, unspecified2G86QN327LIACT
glycerinPDC6A3C0OXIACT
lecithin, soybean1DI56QDM62IACT
mineral oilT5L8T28FGPIACT
polyethylene glycol, unspecified3WJQ0SDW1AIACT
povidone, unspecifiedFZ989GH94EIACT
propylene glycol6DC9Q167V3IACT
shellac46N107B71OIACT
sorbitol506T60A25RIACT
titanium dioxide15FIX9V2JPIACT
water059QF0KO0RIACT

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 7 · 413 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, COATED PELLETS / ORAL65 mgExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
gelatinGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSUSPENSION / RECTAL46.18 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
lecithin, soybeanSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii candidate
7 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8ELIXIR / ORAL5.4 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii candidate
34 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESYSTEM / TOPICAL41 mgExact identifier — unii candidate
30 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
lecithin, soybeanSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii candidate
30 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EINJECTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, DELAYED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, EXTENDED RELEASE / ORAL1229 mgExact identifier — unii candidate
44 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
34 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
0f3010aa-8e70-4465-a1bf-6c0bbfbe70203d59587e-8f28-40d5-9b1b-2aebd50a148f2019-10-07WarningsExact identifier
spl id: 0f3010aa-8e70-4465-a1bf-6c0bbfbe7020
spl set id: 3d59587e-8f28-40d5-9b1b-2aebd50a148f

Reported adverse events (FAERS/openFDA)#

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