FDA.reportPublic FDA data

Mucus Relief

Manufacturer
ARMY AND AIR FORCE EXCHANGE SERVICE | LNK International, Inc.
Effective date
2024-08-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:18:00

Label at a glance#

ProductMucus Relief
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

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

Dosage and administration

take with a full glass of water adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each immediate-release 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 passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

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 overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with a full glass of water
  • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

exchange✓ select™

Mucus Relief
Guaifenesin 400 mg
Expectorant

Relieves Chest Congestion
Thins & Loosens Mucus

4 Hours
of Relief

Immediate
Release

Film Coated
60 Tablets

Actual Size

✓quality
value

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

"SATISFACTION GUARANTEED OR YOUR MONEY BACK"
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.
Hauppauge, NY 11788
1-800-426-9391

50844    ORG011853211

Exchange Select 44-532
Exchange Select 44-532

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-932MUCUS RELIEF (GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]5Legacy NDC20240829_3050af29-6522-4ec2-9230-deba56bffa2f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55301-93255301-932-91

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT

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
d3e7ec1c-6fda-4a83-b76a-ccc019dee7663050af29-6522-4ec2-9230-deba56bffa2f2024-08-27WarningsExact identifier
spl id: d3e7ec1c-6fda-4a83-b76a-ccc019dee766
spl set id: 3050af29-6522-4ec2-9230-deba56bffa2f

Reported adverse events (FAERS/openFDA)#

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