MUCINEX FAST-MAX SEVERE COLD

Manufacturer: Reckitt Benckiser LLC
Effective date: 2014-09-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:35:03

Label at a glance#

ProductMucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength

Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride

Label structure13 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose and sneezing (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 (NIGHT TIME only) temporarily reduces fever

Dosage and administration

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 with product dose as follows or as directed by a doctor adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

Storage and handling

dosing cup provided each 20 mL contains: sodium 12 mg store between 20-25°C (68-77°F) do not refrigerate

Contacts and useful links#

PhoneLabel contact1-866-682-4639

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)	Purposes
Mucinex FAST-MAX DAY TIME Severe Cold
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)	Purposes
Mucinex FAST-MAX NIGHT TIME Cold & Flu
Acetaminophen 650 mg	Pain reliever/fever reducer
Diphenhydramine HCl 25 mg	Antihistamine/cough suppressant
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- runny nose and sneezing (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 (NIGHT TIME only)
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 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

SPL UNCLASSIFIED SECTION

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

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 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
heart disease
diabetes
high blood pressure
thyroid disease
glaucoma (NIGHT TIME only)
trouble urinating due to an enlarged prostate gland
breathing problems 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 6 doses in any 24-hour period
measure only with dosing cup provided with product
dose as follows or as directed by a doctor
adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

dosing cup provided
each 20 mL contains: sodium 12 mg
store between 20-25°C (68-77°F)
do not refrigerate

Inactive ingredients (Mucinex FAST-MAX DAY TIME Severe Cold)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate¹, xanthan gum

1 may contain this ingredient

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

INACTIVE INGREDIENT SECTION

2 may contain this ingredient

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH*

NDC 63824-526-22

Mucinex®
FAST-MAX ^®

DAY TIME
Severe Cold

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

Relieves Aches,
Fever & Sore Throat
Controls Cough
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus

AGE 12+
TWO – 6 fl oz (180 mL) bottles

Mucinex®
FAST-MAX ^®

NIGHT TIME
Cold & Flu

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

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

TOTAL – 12 fl oz (360 mL)
AGE 12+

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type
1424850	Acetaminophen/Dextromethorphan/diphenhydrAMINE/guaiFENesin/Phenylephrine (Pack)	{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 / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack	GPCK Active
1116572	Acetaminophen/Dextromethorphan/guaiFENesin/Phenylephrine (Oral Liquid)	acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD Active
1375932	Acetaminophen/diphenhydrAMINE/Phenylephrine (Oral Liquid)	acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63824-526-22	2023-09-07	C162847	48780-1	9d75b9d0-1c24-f424-e053-dadaa90a57ce	Mucinex® Fast-Max ® Day Time Severe Cold and Mucinex® Fast-Max ® Night Time Cold and Flu Maximum Strength
63824-526-22	2020-01-31	C162847	48780-1	9d75b9d0-1c24-f424-e053-dadaa90a57ce	Mucinex® Fast-Max ® Day Time Severe Cold and Mucinex® Fast-Max ® Night Time Cold and Flu Maximum Strength

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-526-22	ML - Milliliter	63824-526	306f820d-c42c-4c07-bcb5-b4ec8d296da6	1	2014-04-03
63824-020-66	ML - Milliliter	63824-020	de9e6654-c55e-4964-9fd5-8d838013492a	1	2013-11-04
63824-500-64	ML - Milliliter	63824-500	3ab3e9fc-3066-4d28-8760-56cfa448294e	1	2020-05-08
63824-500-66	ML - Milliliter	63824-500	8925fa43-01b4-4b2c-8dfb-c1e9eab63178	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	2
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	2
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	2
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	2
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	2
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	2
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	2
Guaifenesin	ACTIVE MOIETY	495W7451VQ	2
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	2
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	2
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	2
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	2
sorbitol	INACTIVE INGREDIENT	506T60A25R	2
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	2
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	2
water	INACTIVE INGREDIENT	059QF0KO0R	2
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

Mucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength
Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride
MUCINEX FAST-MAX SEVERE COLD
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Acetaminophen
Dextromethorphan Hydrobromide
Dextromethorphan
Guaifenesin
Phenylephrine Hydrochloride
Phenylephrine
anhydrous citric acid
edetate disodium
FD&C blue no. 1
FD&C red no. 40
glycerin
propylene glycol
propyl gallate
water
sodium benzoate
sorbitol
sucralose
trisodium citrate dihydrate
xanthan gum
MUCINEX FAST-MAX NIGHT TIME COLD AND FLU
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
Diphenhydramine Hydrochloride
Diphenhydramine

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63824-526	63824-526-22
63824-020	63824-020-66
63824-500	63824-500-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Acetaminophen	362O9ITL9D	ACTIB
Dextromethorphan Hydrobromide	9D2RTI9KYH	ACTIB
Guaifenesin	495W7451VQ	ACTIB
Phenylephrine Hydrochloride	04JA59TNSJ	ACTIB
anhydrous citric acid	XF417D3PSL	IACT
edetate disodium	7FLD91C86K	IACT
FD&C blue no. 1	H3R47K3TBD	IACT
FD&C red no. 40	WZB9127XOA	IACT
glycerin	PDC6A3C0OX	IACT
propylene glycol	6DC9Q167V3	IACT
propyl gallate	8D4SNN7V92	IACT
water	059QF0KO0R	IACT
sodium benzoate	OJ245FE5EU	IACT
sorbitol	506T60A25R	IACT
sucralose	96K6UQ3ZD4	IACT
trisodium citrate dihydrate	B22547B95K	IACT
xanthan gum	TTV12P4NEE	IACT
Acetaminophen	362O9ITL9D	ACTIB
Diphenhydramine Hydrochloride	TC2D6JAD40	ACTIB
Phenylephrine Hydrochloride	04JA59TNSJ	ACTIB
anhydrous citric acid	XF417D3PSL	IACT
edetate disodium	7FLD91C86K	IACT
FD&C blue no. 1	H3R47K3TBD	IACT
FD&C red no. 40	WZB9127XOA	IACT
glycerin	PDC6A3C0OX	IACT
propylene glycol	6DC9Q167V3	IACT
propyl gallate	8D4SNN7V92	IACT
water	059QF0KO0R	IACT
sodium benzoate	OJ245FE5EU	IACT
sorbitol	506T60A25R	IACT
sucralose	96K6UQ3ZD4	IACT
trisodium citrate dihydrate	B22547B95K	IACT
xanthan gum	TTV12P4NEE	IACT

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 10 · 545 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propyl gallate	PROPYL GALLATE	8D4SNN7V92	TABLET / ORAL		7 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE, LIQUID FILLED / ORAL		360 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		414 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, SOLUTION / INTRA-ARTICULAR		25 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION, SOLUTION / INTRAMUSCULAR		1188 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / RECTAL		773 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / TOPICAL	4.35 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / INTRAVENOUS		41 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / RESPIRATORY (INHALATION)		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / SUBCUTANEOUS		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	GRANULE, FOR SUSPENSION / ORAL		4950 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	GEL / TOPICAL		3 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		81 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SUSPENSION / RESPIRATORY (INHALATION)		2 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
trisodium citrate dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	CONCENTRATE / ORAL		104 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
017e05b3-7d1b-321b-e063-6294a90ab2b4			19228ba2-098d-47d0-9029-804b4627f98d	2023-07-27	Warnings	Exact identifier spl set id: 19228ba2-098d-47d0-9029-804b4627f98d

Reported adverse events (FAERS/openFDA)#

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

MUCINEX FAST-MAX SEVERE COLD

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Uses

Warnings

Liver warning

SPL UNCLASSIFIED SECTION

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

Directions

Other information

Inactive ingredients (Mucinex FAST-MAX DAY TIME Severe Cold)

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

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - Kit Carton

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#