FDA.reportPublic FDA data

GILTUSS DIABETIC DM

Manufacturer
Gil Pharmaceutical Corp | SEAWAY PHARMA
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:38:39

Label at a glance#

ProductGILTUSS DIABETIC DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredient (In each 10 mL)                                       Purpose

Dextromethorphan HBr. 30 mg ......................... Cough Suppresant

Uses

  • temporarily relieves:
    • cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

WARNINGS SECTION

Warnings

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • When using this product do not use more than directed.

INDICATIONS & USAGE SECTION

Ask a doctor before use if you have

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

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache as these could be signs of a serious condition.

OTC - PURPOSE SECTION

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

  • 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 exceed recommended dosage
  • do not take more than 4 doses in any 24-hour period
  • use enclosed dosing cup
  • mL= milliliter

Adults and children over 12 years

10 mL every 8 hours

Children under 6 years to under 12 years

5 mL every 8 hours

Children 4 years to under 6 years

2.5 mL *every 8 hours

Children under 4 years

Do not use

* use appropriate measuring syringe or measuring cup

OTHER SAFETY INFORMATION

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 ingredients

Acesulfame potassium, citric acid, flavor, glycerin, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Giltuss Diabetic DM - NDC 58552-149-04 - Bottle Label

image descriptionimage description

Giltuss Diabetic DM - NDC 58552-149-04 - Carton Label

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN4
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD4
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY4
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-149-04GILTUSS DIABETIC DM1 in 1 CARTONSOLUTION14
58552-149-04GILTUSS DIABETIC DM118 mL in 1 BOTTLESOLUTION1184

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-14958552-149-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-10-24full-release2026-06-01 00:29:59

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 DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corpbd367ce1-996b-45bc-865e-b6aafe0ea7b02025-10-09WarningsExact identifier
ndc (package): 58552-149-04
ndc (product): 58552-149
ndc11 (package): 58552014904
spl id: 40b94d7e-722e-6dce-e063-6394a90a2e10
spl set id: bd367ce1-996b-45bc-865e-b6aafe0ea7b0

Reported adverse events (FAERS/openFDA)#

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