FDA.reportPublic FDA data

Mucus Relief

Manufacturer
Allegiant Health
Effective date
2021-04-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:12

Label at a glance#

ProductMucus Relief Immediate Release
Active ingredientGUAIFENESIN
Label structure10 sections

Dosage and administration

Adults and children12 years of age and older: Take 1 caplet every 4 hours with a full of glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under 12 years of age: do not use

Storage and handling

store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F) keep in a dry place and do not expose to heat

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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 accompanied by excessive phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • do not use for more than 7 days

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children12 years of age and older: Take 1 caplet every 4 hours with a full of glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • do not use if imprinted safety seal under cap is broken or missing

Storage

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F)
  • keep in a dry place and do not expose to heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

Questions

OTC - QUESTIONS SECTION

Call 1-888-952-0050

Monday through Friday 9AM - PM EST.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucus Relief
Mucus Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN4
359601guaifenesin 400 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

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

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
69168-916-60Mucus ReliefImmediate Release1 in 1 CARTONTABLET14
69168-916-60Mucus ReliefImmediate Release60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-916MUCUS RELIEF IMMEDIATE RELEASE (MUCUS RELIEF) TABLET [ALLEGIANT HEALTH]4Legacy NDC, 2 package rows20240509_237f7d7a-f394-4795-980c-3d71efe2cccc.zip

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
69168-91669168-916-60

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
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
POVIDONEFZ989GH94EIACT

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
3565bf21-27c7-4f08-a2b3-1d6cb3383733237f7d7a-f394-4795-980c-3d71efe2cccc2021-04-19WarningsExact identifier
spl set id: 237f7d7a-f394-4795-980c-3d71efe2cccc

Reported adverse events (FAERS/openFDA)#

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