FDA.reportPublic FDA data

Guaifenesin Tablets 400 mg

Manufacturer
APNAR PHARMA LP | INVAHEALTH INC | APNAR PHARMA LLP
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:15

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure12 sections

Boxed warning

Caution: do not use if imprinted seal under cap is broken or missing.

Storage and handling

Other Information Store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

BOXED WARNING SECTION

Caution: do not use if imprinted seal under cap is broken or missing.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (per tablet)

Guaifenesin USP 400 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Use

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

WARNINGS SECTION

Warnings

Ask 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)

Stop use and ask a doctor if

  • Symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition

If pregnant or breast-feeding, ask a healthcare 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 Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to under 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

STORAGE AND HANDLING SECTION

Other Information

Store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Maltodextrin, Povidone, Silicon dioxide and Stearic acid

OTC - QUESTIONS SECTION

Questions or concerns?

  • 1-855-642-2594

SPL UNCLASSIFIED SECTION

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Made in USA

Rev.: 05/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 24689-144-01

Guaifenesin Tablets 400 mg

Expectorant

100 Tablets

Guaifenesin Tablets 400 mg - Label - 100sGuaifenesin Tablets 400 mg - Label - 100s

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24689-144-01Guaifenesin100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-144GUAIFENESIN TABLET [APNAR PHARMA LP]2Current NDC, Legacy NDC, 1 package rows20231022_e5004c10-3877-c199-e053-2a95a90aa8ac.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-144-01EA - Each24689-144e334d3b3-54dd-4f72-bd99-7aa84cd61e0912023-02-06

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
24689-14424689-144-01

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
MALTODEXTRIN7CVR7L4A2DIACT
GUAIFENESIN495W7451VQACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT

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
GuaifenesinGUAIFENESINAPNAR PHARMA LPe5004c10-3877-c199-e053-2a95a90aa8ac2023-10-21Boxed warning, WarningsExact identifier
ndc (package): 24689-144-01
ndc (product): 24689-144
ndc11 (package): 24689014401
spl id: 0835c630-aaf2-b231-e063-6394a90a46c7
spl set id: e5004c10-3877-c199-e053-2a95a90aa8ac

Reported adverse events (FAERS/openFDA)#

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