FDA.reportPublic FDA data

Guaifenesin 200mg

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:05

Label at a glance#

ProductGuaifenesin 200mg
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

GUAIFENESIN 200 MG TABLETS

MarlexPharmaceuticals, Inc.

----------

Drug Fact

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Guaifenesin 200 mg Tablets

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, come back or is accompanied by fever, rash, or persistent headache. There 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

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Suppliedsection listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count200 mg
300071610-434-18

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20200619JH

PRINCIPAL DISPLAY PANEL - 200 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-434 - Guaifenesin 200 mg Tablets
Bottle Label 200 mgBottle Label 200 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197741guaiFENesin 200 MG Oral TabletPSN2
197741guaifenesin 200 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
71610-434-18Guaifenesin 200mg3000 in 1 BOTTLETABLET30002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-434GUAIFENESIN 200MG (GUAIFENESIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 1 package rows20250112_45ac210a-8c54-4469-8e10-e6fe52b89cb5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-434-18EA - Each71610-4348afbd3cb-1fb0-497c-a18c-6f4d916de84c12020-08-06
10135-681-01EA - Each10135-6816b0ba7f5-7ae3-46b9-8304-555b4f8e6a9e12019-04-11

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71610-43471610-434-18
10135-681

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
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
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 200mgGUAIFENESINAphena Pharma Solutions - Tennessee, LLC45ac210a-8c54-4469-8e10-e6fe52b89cb52025-01-09WarningsExact identifier
ndc (package): 71610-434-18
ndc (product): 71610-434
ndc11 (package): 71610043418
spl id: 2b4b8161-b037-f244-e063-6294a90ae372
spl set id: 45ac210a-8c54-4469-8e10-e6fe52b89cb5

Reported adverse events (FAERS/openFDA)#

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