FDA.reportPublic FDA data

GILTUSS DIABETIC EX

Manufacturer
Gil Pharmaceutical Corp | Ganules India Limited
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:57:13

Label at a glance#

ProductGILTUSS DIABETIC EX
Active ingredientGUAIFENESIN
Label structure12 sections

Indications and uses

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

Dosage and administration

do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours do not exceed 4 tablets in 24 hours children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient Purpose (in each extended-release bi-layer tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, 600 mg....................................................................Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • Do not use for children under 12 years

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

Cough lasts more than than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of 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 accidental overdose, get medical or professional help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours
  • do not exceed 4 tablets in 24 hours
  • children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • Tamper evident: do not use if the carton is open or if printed seal on bottle is broken or missing
  • Store between 20°-25°C (68° -77°F)
  • SAVE CARTON FOR COMPLETE DRUG FACTS

INACTIVE INGREDIENT SECTION

Inactive ingredients:carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose, sodium starch  glycolate.

Questions or comments?

OTC - QUESTIONS SECTION

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

revised: 08/25

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GILTUSS DIABETIC EX EXPECTORANT / EXPECTORANTE (Guaifenesin 600 mg) - NDC 58552-339-20 - 20 Tabs Bottle label

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN2
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD2
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY2

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
58552-339-07GILTUSS DIABETIC EX7 in 1 BLISTER PACKTABLET72
58552-339-07GILTUSS DIABETIC EX1 in 1 CARTONTABLET12
58552-339-20GILTUSS DIABETIC EX20 in 1 BOTTLETABLET202
58552-339-20GILTUSS DIABETIC EX1 in 1 CARTONTABLET12

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-33958552-339-20, 58552-339-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-10-09monthly-update2026-06-03 17:38:55

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 DIABETIC EXGILTUSS DIABETIC EXGil Pharmaceutical Corpab7915e7-323a-4fe1-887a-a3bd3f0aac982026-05-13WarningsExact identifier
ndc (package): 58552-339-20
ndc (package): 58552-339-07
ndc (product): 58552-339
ndc11 (package): 58552033920
ndc11 (package): 58552033907
spl id: 51b28c77-c6c9-2343-e063-6394a90a4805
spl set id: ab7915e7-323a-4fe1-887a-a3bd3f0aac98

Reported adverse events (FAERS/openFDA)#

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