FDA.reportPublic FDA data

Mucus Relief

Manufacturer
Allegiant Health
Effective date
2019-03-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-07-31 05:10:11

Label at a glance#

ProductMucus Relief Immediate Release
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

Dosage and administration

Adults and children 12 years of age and older: t ake 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 of age:  do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400mg

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

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 health 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 children 12 years of age and older: 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 of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to heat
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate dihydrate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Questions or comments?

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369168330177GTIN-13: 0369168330177
EAN-13: 0369168330177
GTIN-12: 369168330177
UPC-A: 369168330177
GTIN storage (14 digits): 00369168330177		370---health-a2z-mucus-relief-1.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

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
69168-37069168-370-01, 69168-370-30, 69168-370-41, 69168-370-17, 69168-370-60, 69168-370-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DICALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52019-03-26full-release2026-05-31 23:59:15

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 Relief Immediate ReleaseGUAIFENESINAllegiant Health221d64a2-b8c7-435a-aae4-fb58fd38108f2019-03-26WarningsExact identifier
ndc (package): 69168-370-60
ndc (package): 69168-370-30
ndc (package): 69168-370-17
ndc (package): 69168-370-01
ndc (package): 69168-370-41
ndc (package): 69168-370-02
ndc (product): 69168-370
ndc11 (package): 69168037017
ndc11 (package): 69168037060
ndc11 (package): 69168037001
ndc11 (package): 69168037041
ndc11 (package): 69168037002
ndc11 (package): 69168037030
spl id: d968aa38-9d60-4ca2-adf3-68cf19534a6b
spl set id: 221d64a2-b8c7-435a-aae4-fb58fd38108f

Reported adverse events (FAERS/openFDA)#

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