FDA.reportPublic FDA data

Mucus Relief - Guaifenesin 400 mg Tablets

Manufacturer
TWIN MED LLC
Effective date
2026-03-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:51:29

Label at a glance#

ProductMucus Relief
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

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

Dosage and administration

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

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 rid the bronchial passageway of bothersome mucus
  • helps make coughs 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)

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 (1-800-222-1222) immediately.

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

OTHER SAFETY INFORMATION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to heat
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Stearic Acid

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-844-912-4012

SPL UNCLASSIFIED SECTION

Manufactured for:

TwinMed LLC.

11333 Greenstone Ave

Santa Fe Springs, CA 90670

ProCureProducts.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guai 400Guai 400

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN5
359601guaifenesin 400 MG Oral TabletSCD5

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-311-03Mucus Relief300 in 1 BOTTLETABLET3005

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
55681-31155681-311-03

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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
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 MGTWIN MED LLCe31bd69f-97ab-9d99-e053-2995a90a580e2026-03-24WarningsExact identifier
ndc (package): 55681-311-03
ndc (product): 55681-311
ndc11 (package): 55681031103
spl id: 4dc83923-e74d-3466-e063-6294a90a4f7d
spl set id: e31bd69f-97ab-9d99-e053-2995a90a580e

Reported adverse events (FAERS/openFDA)#

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