FDA.reportPublic FDA data

Guaifenesin

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:55

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure13 sections

Indications and uses

helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone 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 caplet every 4 hours children under 12 years: do not use

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone 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 cough lasts more then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 caplet every 4 hours
  • children under 12 years: do not use

Other information

SPL UNCLASSIFIED SECTION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, magnesium stearate, maltodextrin, microsrystalline cellulose, providone, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday

SPL UNCLASSIFIED SECTION

Drug Facts continued on back of label

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

Distributed by: Reliable-1 Laboratoreis LLC

Valley Stream, Ny 11580 www.reliable1labs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-061-06

Reliable-1 Laboratories

Guaifenesin 400 mg

Expectorant

60 CAPLETS

pdppdp

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-061-062023-03-29C16284748780-1f386c649-d238-0266-e053-dadaa90a7c1aGuifenisen 400 mg
69618-061-062023-01-30C16284748780-1f386c649-d238-0266-e053-dadaa90a7c1aGuifenisen 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-061-06Guaifenesin60 in 1 BOTTLE, PLASTICTABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-061GUAIFENESIN TABLET [RELIABLE 1 LABORATORIES LLC]5Current NDC, Legacy NDC, 1 package rows20250117_ae469d4f-91c4-cff0-e053-2995a90a0497.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-061-06EA - Each69618-0619467aaf0-ae81-4301-a553-1077f9182d4412021-03-02

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-06169618-061-06

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
GUAIFENESIN495W7451VQACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT

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
GuaifenesinGUAIFENESINReliable 1 Laboratories LLCae469d4f-91c4-cff0-e053-2995a90a04972025-01-15WarningsExact identifier
ndc (package): 69618-061-06
ndc (product): 69618-061
ndc11 (package): 69618006106
spl id: 2bc81e27-90e3-930d-e063-6394a90a699d
spl set id: ae469d4f-91c4-cff0-e053-2995a90a0497

Reported adverse events (FAERS/openFDA)#

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