FDA.reportPublic FDA data

Mucus Relief

Manufacturer
Safrel Pharmaceuticals, LLC
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:16:20

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

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

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)

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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

  • 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

  • each tablet contains: sodium 1.24 mg VERY LOW SODIUM
  • 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
  • read all product information before using
  • 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, microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions or Comments

OTC - QUESTIONS SECTION

Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrelpharma.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 ct

200 ct200 ct300 ct

300 ct300 ct500 ct

500 ct500 ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71309-008-022025-06-27C16284748780-1d6a99b39-e2f7-a426-e053-dadaa90af4c2Mucus Relief Guaifenesin 400 mg Caplets
71309-008-032025-06-27C16284748780-1d6a99b39-e2f7-a426-e053-dadaa90af4c2Mucus Relief Guaifenesin 400 mg Caplets
71309-008-052025-06-27C16284748780-1d6a99b39-e2f7-a426-e053-dadaa90af4c2Mucus Relief Guaifenesin 400 mg Caplets
71309-008-022025-01-30C16284748780-1d6a99b39-e2f7-a426-e053-dadaa90af4c2Mucus Relief Guaifenesin 400 mg Caplets
71309-008-032025-01-30C16284748780-1d6a99b39-e2f7-a426-e053-dadaa90af4c2Mucus Relief Guaifenesin 400 mg Caplets
71309-008-052025-01-30C16284748780-1d6a99b39-e2f7-a426-e053-dadaa90af4c2Mucus Relief Guaifenesin 400 mg Caplets
71309-008-022022-02-27C16284748780-1d6a99b39-e2f7-a426-e053-dadaa90af4c2Mucus Relief Guaifenesin 400 mg Caplets
71309-008-022022-01-28C16284748780-1d6a99b39-e2f7-a426-e053-dadaa90af4c2Mucus Relief Guaifenesin 400 mg Caplets

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-008MUCUS RELIEF (GUAIFENESIN 400 MG) TABLET [SAFREL PHARMACEUTICALS, LLC]4Legacy NDC20240101_b0c66e35-b348-4ff5-e053-2a95a90a5b57.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71309-00871309-008-02, 71309-008-03, 71309-008-05

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
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT
MALTODEXTRIN7CVR7L4A2DIACT
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT

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
38874088-70c7-6f5d-e063-6394a90a3940b0c66e35-b348-4ff5-e053-2a95a90a5b572025-06-27WarningsExact identifier
spl set id: b0c66e35-b348-4ff5-e053-2a95a90a5b57

Reported adverse events (FAERS/openFDA)#

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