FDA.reportPublic FDA data

Giltuss EX Expectorant

Manufacturer
Gil Pharmaceutical Corp | Dextrum Laboratories Inc
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:38:37

Label at a glance#

ProductGiltuss EX Expectorant
Active ingredientGUAIFENESIN
Label structure11 sections

Storage and handling

Other information store at room temperature 15°-30°C (59°-86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 10 mL)

Guaifenesin, 400 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifcough lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosing cup
  • keep dosage cup for use with this product
  • ml = milliliters
    adults and children 12 years and over10 mL every 4 hours
    children 6 to under 12 years of age5 mL every 4 hours
    children 4 to under 6 years of age2.5 mL every 4 hours
    children under 4 years of ageConsult a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE DRUG FACTS

INACTIVE INGREDIENT SECTION

Inactive ingredientscitric acid, glycerin, methylparaben. natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

OTC - QUESTIONS SECTION

Questions or comments?Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

SPL UNCLASSIFIED SECTION

Tamper Evident: do not use if safety seal is broken or missing.

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Giltuss® EX EXPECTORANT

ALCOHOL FREE. SUGAR FREE. DYE FREE. NON-DROWSY

RELIEVES

CHEST CONGESTION

LOOSENS AND LIQUIFIES PHLEGM

LIQUIFIES AND REMOVE MUCUS

HELPS TO EXPEL PHLEGM IN CHEST AND THROAT

TUTTI FRUTTI FLAVOR

4FL OZ (118 mL)

58552-14558552-145

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310625guaiFENesin 200 MG in 5 mL Oral SolutionPSN6
310625guaifenesin 40 MG/ML Oral SolutionSCD6
310625guaifenesin 200 MG per 5 ML Oral SolutionSY6
310625guaifenesin 400 MG per 10 ML Oral SolutionSY6

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
58552-145-042022-01-30C16284748780-1d6a99b39-75ec-a426-e053-dadaa90af4c2Giltuss EX Expectorant
58552-145-042022-01-30C16284748780-1d6a99b39-75ec-a426-e053-dadaa90af4c2Giltuss EX Expectorant
58552-145-042022-01-28C16284748780-1d6a99b39-75ec-a426-e053-dadaa90af4c2Giltuss EX Expectorant
58552-145-042022-01-28C16284748780-1d6a99b39-75ec-a426-e053-dadaa90af4c2Giltuss EX Expectorant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-145-04Giltuss EX Expectorant118 mL in 1 BOTTLESOLUTION1186
58552-145-04Giltuss EX Expectorant1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-145-04ML - Milliliter58552-145a6fb953c-838b-4357-98a6-4a92dfce7ad312021-01-08

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-14558552-145-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SUCRALOSE96K6UQ3ZD4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-24full-release2026-06-01 00:29:57

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
Giltuss EX ExpectorantGUAIFENESINGil Pharmaceutical Corpa8c53c14-ba82-2c68-e053-2a95a90a98942025-10-09WarningsExact identifier
ndc (package): 58552-145-04
ndc (product): 58552-145
ndc11 (package): 58552014504
spl id: 40b8ef34-8eeb-c72d-e063-6294a90aff26
spl set id: a8c53c14-ba82-2c68-e053-2a95a90a9894

Reported adverse events (FAERS/openFDA)#

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