FDA.reportPublic FDA data

Maximum Strength Mucus Relief

Manufacturer
Hyvee Inc | Guardian Drug Company
Effective date
2026-03-23
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 01:51:05

Label at a glance#

ProductMaximum Strength Mucus Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

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: 20 mL 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°C (59-86°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


USE(S)

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, chronic 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 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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: 20 mL 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°C (59-86°F)
  • do not refrigerate
  • dosing cup provided

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HyVee®

 

*COMPARE TO the Active Ingredients in Maximum Strength MUCINEX® FAST MAX DM MAX


Maximum Strength
Mucus Relief 

Cough Suppressant / Expectorant


 

Controls Cough 

Relieves Chest Congestion    

Thins and loosens Mucus


6 FL OZ (177 mL)

CHERRY FLAVOR

 

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN2
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD2
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY2
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130075450824605GTIN-13: 0075450824605
EAN-13: 0075450824605
GTIN-12: 075450824605
UPC-A: 075450824605
GTIN storage (14 digits): 00075450824605		628-6-hv-front.jpg
QR code linkQR Codehyvee.info/S78UDT628-6-hv-front.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-630-58Maximum Strength Mucus Relief177 mL in 1 BOTTLELIQUID1772

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
42507-63042507-630-58

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
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESINHyvee Inc44eafc83-8e7b-89b8-e063-6394a90ab0bc2026-03-23WarningsExact identifier
ndc (package): 42507-630-58
ndc (product): 42507-630
ndc11 (package): 42507063058
spl id: a3288413-3c43-4d8c-b4a9-e7a68da90d44
spl set id: 44eafc83-8e7b-89b8-e063-6394a90ab0bc

Reported adverse events (FAERS/openFDA)#

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