FDA.reportPublic FDA data

Mucus Relief

Manufacturer
Richmond Pharmaceuticals, Inc. | Advance Pharmaceutical Inc.
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:48

Label at a glance#

ProductMucus Relief
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus and make cough more productive

Dosage and administration

adults and children 12 years of age and over: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. children under 12 years: do not use

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus and make cough more productive

Warnings

WARNINGS SECTION

ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accompanied by excessive phlegm (mucus)

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.

IN CASE OF PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

stop use and ask a doctor

OTC - STOP USE SECTION

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness

Directions:

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years: do not use

OTHER  INFORMATION

OTHER SAFETY INFORMATION

  • store at 15°-30°C (59°-86°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, magnesium stearate, maltodextrin,  microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions or Comments

OTC - QUESTIONS SECTION

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Guaifenesin 400 mg...Expectorant
NDC- 54738-981-30... 30 CAPLETS

IMG_4690IMG_4690

NDC- 54738-981-60... 60 CAPLETS

IMG_4691IMG_4691

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN2
359601guaifenesin 400 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130054738981308GTIN-13: 0054738981308
EAN-13: 0054738981308
GTIN-12: 054738981308
UPC-A: 054738981308
GTIN storage (14 digits): 00054738981308		IMG_4690.jpg
BarcodeEAN-130054738981605GTIN-13: 0054738981605
EAN-13: 0054738981605
GTIN-12: 054738981605
UPC-A: 054738981605
GTIN storage (14 digits): 00054738981605		IMG_4691.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-981-30Mucus Relief30 in 1 BOTTLETABLET302
54738-981-60Mucus Relief60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-981MUCUS RELIEF (GUAIFENESIN 400 MG) TABLET [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20171030_26924bee-32cc-4499-beb0-2650ff8eb1da.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-981-30EA - Each54738-981ed28af0a-7872-42d0-bcfb-ef0fc05623a712018-05-09
54738-981-60EA - Each54738-9817be0902c-a6f6-42ba-a4df-c834b96f056f12017-11-06

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54738-98154738-981-30, 54738-981-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MALTODEXTRIN7CVR7L4A2DIACT
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
GUAIFENESIN495W7451VQACTIB

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
Mucus ReliefGUAIFENESIN 400 MGRichmond Pharmaceuticals, Inc.26924bee-32cc-4499-beb0-2650ff8eb1da2017-10-30WarningsExact identifier
ndc (package): 54738-981-30
ndc (package): 54738-981-60
ndc (product): 54738-981
ndc11 (package): 54738098130
ndc11 (package): 54738098160
spl id: 5cc3bf1b-4684-6a53-e053-2a91aa0abfa6
spl set id: 26924bee-32cc-4499-beb0-2650ff8eb1da

Reported adverse events (FAERS/openFDA)#

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