Maximum strength Tussnex FM DM Max

Manufacturer: Guardian Drug Company
Effective date: 2024-12-19
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:45:16

Label at a glance#

ProductMaximum strength Tussnex FM DM Max

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure8 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Dosage and administration

do not take more than 6 doses in any 24 hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Adults & children 12 years & older: 20mL every 4 hours Children under 12 years of age: Do not use

Storage and handling

each 20 mL contains: potassium 20 mg, sodium 20 mg store between 15-30 o C (59-86 o F) do not refrigerate dosing cup provided

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
the intensity of coughing
the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

Do not use

for children under 12 years of age
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

persistent or chronic cough such as occurs with smoking, asthma, chronuc bronchitis or emphysema
cough that occurs with too much phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 6 doses in any 24 hour period
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
Adults & children 12 years & older: 20mL every 4 hours
Children under 12 years of age: Do not use

Other information

STORAGE AND HANDLING SECTION

each 20 mL contains: potassium 20 mg, sodium 20 mg
store between 15-30^oC (59-86^oF)
do not refrigerate
dosing cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, D&C red 33, dextrose, FD&C red 40, flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compare to active ingredients in Mucinex^®Fast-Max^TMDM Max

Maximum strength

Tussnex FM DM Max

Dextromethorphan HBr

Cough suppressant

Guaifenesin

Expectorant

Multi-symptom

Relieves chest congestion

Thins and loosens mucus

Soothes cough

Dosing lasts 4 hours

For ages 12 & over

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1020138	Dextromethorphan/guaiFENesin (Oral Liquid)	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	4
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	4
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	4
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53041-628-58	Maximum strength Tussnex FM DM Max	177 mL in 1 BOTTLE	LIQUID	177		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53041-628	MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]	4	Current NDC, Legacy NDC, 1 package rows	20241222_0bae53e3-9661-4bc6-9fcc-da7fa131b034.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

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

Maximum strength Tussnex FM DM Max
Dextromethorphan HBr, Guaifenesin
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
ANHYDROUS CITRIC ACID
DEXTROSE
D&C RED NO. 33
FD&C RED NO. 40
GLYCERIN
METHYLPARABEN
POTASSIUM SORBATE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SODIUM HYDROXIDE
SORBITOL
SUCRALOSE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53041-628	53041-628-58

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
DEXTROSE	IY9XDZ35W2	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	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 5 · 246 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii+route 36 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii+route 24 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SOLUTION / ORAL	2489 mg/5ml		Exact identifier — unii+route 22 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, CHEWABLE / ORAL		1286 mg	Exact identifier — unii+route 22 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii+route 44 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii+route 24 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 36 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	CONCENTRATE / ORAL	400 mg		Exact identifier — unii+route 22 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii+route 24 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii+route 38 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET / ORAL	183.66 mg		Exact identifier — unii+route 22 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route 36 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		48 mg	Exact identifier — unii+route 44 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SYRUP / ORAL		1 mg	Exact identifier — unii+route 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii+route 36 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii+route 38 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SUSPENSION / ORAL		570 mg	Exact identifier — unii+route 44 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE, LIQUID FILLED / ORAL	0.01 mg		Exact identifier — unii+route 24 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SOLUTION / ORAL		2 mg	Exact identifier — unii+route 24 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	ELIXIR / ORAL		90 mg	Exact identifier — unii+route 44 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET / ORAL	0.24 mg		Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii+route 36 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, EXTENDED RELEASE / ORAL	103.95 mg		Exact identifier — unii+route 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	PASTILLE / ORAL	826 mg		Exact identifier — unii+route 22 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL		1 mg	Exact identifier — unii+route 24 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 2 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
Maximum strength Tussnex FM DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Guardian Drug Company	0bae53e3-9661-4bc6-9fcc-da7fa131b034	2024-12-19	Warnings	Exact identifier ndc (package): 53041-628-58 ndc (product): 53041-628 ndc11 (package): 53041062858 spl id: e39a2556-4a5b-4306-b2d1-b93b75d39b06 spl set id: 0bae53e3-9661-4bc6-9fcc-da7fa131b034

Reported adverse events (FAERS/openFDA)#

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