FDA.reportPublic FDA data

maximum strength mucus relief severe congestion and cough

Manufacturer
SuperValu Inc.,
Effective date
2017-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:26

Label at a glance#

Productmaximum strength mucus relief severe congestion and cough
Active ingredientdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Label structure9 sections

Indications and uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • 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

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 • mL = milliliter • 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

• each 20 mL contains: sodium 8 mg • store at room temperature • do not refrigerate • dosing cup provided

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients
(in each 20 mL)		Purposes

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

Phenylephrine HCl 10 mg

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • 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

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 you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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 a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with rash or persistent headache. 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 1-800-222-1222

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
  • mL = milliliter
  • 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

  • each 20 mL contains: sodium 8 mg
  • store at room temperature
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-866-932-7948

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUALINE®

NDC 41163-738-06

Compare toMucinex® Fast- Max™ Maximum strength Severe Congestion & Cough active ingredients*

maximum strength‡

severe congestion and cough


dextromethorphan HBr (cough suppressant)
guaifenesin (expectorant)
phenylephrine HCl (nasal decongestant)

  • controls cough
  • relieves nasal and chest congestion
  • thins and loosens mucus

6 FL OZ (180 mL)


for ages 12+

Tamper evident: do not use if printed seal under cap is broken or missing.

‡Maximum Strength per 4 hour dose.

DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA

877-932-7948, supervaluprivatebrands.com

‡Maximum Strength per 4 hour dose.

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ®

Fast -Max® Maximum Strength Severe Congestion & Cough.

Equaline maximum strength mucus relief severe congestion and cough 6 FL OZ (180 mL)
Equaline maximum strength mucus relief severe congestion and cough 6 FL OZ (180 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN1
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY1
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-738-06maximum strength mucus relief severe congestion and cough180 mL in 1 BOTTLELIQUID1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-738MAXIMUM STRENGTH MUCUS RELIEF SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SUPERVALU INC.,]1Current NDC, Legacy NDC, 1 package rows20170907_3bb76952-15d8-4a36-a392-60f62b845f09.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-73841163-738-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
dextromethorphan hydrobromide9D2RTI9KYHACTIB
guaifenesin495W7451VQACTIB
phenylephrine hydrochloride04JA59TNSJACTIB
anhydrous citric acidXF417D3PSLIACT
edetate disodium7FLD91C86KIACT
FD&C Blue NO. 1H3R47K3TBDIACT
FD&C Red NO. 40WZB9127XOAIACT
POTASSIUM CITRATEEE90ONI6FFIACT
propylene glycol6DC9Q167V3IACT
propyl gallate8D4SNN7V92IACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
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 relief severe congestion and coughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESuperValu Inc.,3bb76952-15d8-4a36-a392-60f62b845f092017-09-01WarningsExact identifier
ndc (package): 41163-738-06
ndc (product): 41163-738
ndc11 (package): 41163073806
spl id: 3bb76952-15d8-4a36-a392-60f62b845f09
spl set id: 3bb76952-15d8-4a36-a392-60f62b845f09

Reported adverse events (FAERS/openFDA)#

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