FDA.reportPublic FDA data

Guaifenesin 400mg

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:15:58

Label at a glance#

ProductGuaifenesin 400mg
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

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

Dosage and administration

Do not take more than 6 doses in any 24-hour period. This product is not intended for use in children under 12 years of age Adults & children 12 years and over: 1 to 2 tablets every 4 hours Children under 12 years: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

GUAIFENESIN400MG CAPLETS

MarlexPharmaceuticals, Inc.

----------

Drug Fact

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Guaifenesin 400 mg Caplets

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and 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 too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness.

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

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

  • Do not take more than 6 doses in any 24-hour period.
  • This product is not intended for use in children under 12 years of age
  • Adults & children 12 years and over: 1 to 2 tablets every 4 hours
  • Children under 12 years: do not use

Other Information:

SAFE HANDLING WARNING SECTION

  • Store at 15°C-30°C (59°F-86°F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Maltodextrin, Povidone, Silicon Dioxide, Stearic acid.

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 03/24 AA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0790-30
Guaifenesin
400 mg
30 CAPLETS

790-30790-30

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0790-60
Guaifenesin
400 mg
60 CAPLETS

790-60790-60

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN2
359601guaifenesin 400 MG Oral TabletSCD2

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
10135-790-30Guaifenesin 400mg30 in 1 BOTTLETABLET302
10135-790-60Guaifenesin 400mg60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-790-30EA - Each10135-790f967b329-d3e1-41d9-aa18-46cc65e656f712025-05-14
10135-790-60EA - Each10135-7906c93de7b-57ca-4ea9-994d-2fa40bc8fd0312025-05-14

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10135-79010135-790-30, 10135-790-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
MALTODEXTRIN7CVR7L4A2DIACT
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
Guaifenesin 400mgGUAIFENESINMarlex Pharmaceuticals Inc13f4db4e-687e-9d7b-e063-6294a90ab0882025-11-13WarningsExact identifier
ndc (package): 10135-790-60
ndc (package): 10135-790-30
ndc (product): 10135-790
ndc11 (package): 10135079060
ndc11 (package): 10135079030
spl id: 437e33ae-1e1d-56a8-e063-6294a90abc66
spl set id: 13f4db4e-687e-9d7b-e063-6294a90ab088

Reported adverse events (FAERS/openFDA)#

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