FDA.reportPublic FDA data

Giltuss Honey DM Cough

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 01:38:36

Label at a glance#

ProductGiltuss Honey DM Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
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)

Dextromethorphan HBr, 30 mg

OTC - PURPOSE SECTION

Purposes

Cough Suppresant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not useif 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.

OTC - ASK DOCTOR 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

OTC - STOP USE SECTION

Stop use and ask a doctor ifcough lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs 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 4 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 6-8 hours
    children 6 to under 12 years of age5 mL every 6-8 hours
    children 4 to under 6 years of age2.5 mL every 6-8 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 ingredientsnatural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, 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®

Honey DM Cough

Made with real honey

ALCOHOL FREE. DYE FREE. NON-DROWSY

RELIEVES

PERSISTENT COUGH UP TO 8 HOURS

HONEY LEMON FLAVOR.

4FL OZ (118 mL)

58552-143 Honey DM58552-143 Honey DM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN6
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD6
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY6
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58552-143-042022-01-30C16284748780-1d6a99b39-4176-a426-e053-dadaa90af4c2Giltuss Honey DM
58552-143-042022-01-30C16284748780-1d6a99b39-4176-a426-e053-dadaa90af4c2Giltuss Honey DM
58552-143-042022-01-28C16284748780-1d6a99b39-4176-a426-e053-dadaa90af4c2Giltuss Honey DM
58552-143-042022-01-28C16284748780-1d6a99b39-4176-a426-e053-dadaa90af4c2Giltuss Honey DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-143-04Giltuss Honey DM Cough118 mL in 1 BOTTLESOLUTION1186
58552-143-04Giltuss Honey DM Cough1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-143-04ML - Milliliter58552-143774e501c-3fd4-4ec9-91a0-21a5e471011512022-07-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-14358552-143-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCRALOSE96K6UQ3ZD4IACT
HONEYY9H1V576FHIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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 Honey DM CoughDEXTROMETHORPHAN HBRGil Pharmaceutical Corpa8c08532-1169-6603-e053-2a95a90a34842025-10-09WarningsExact identifier
ndc (package): 58552-143-04
ndc (product): 58552-143
ndc11 (package): 58552014304
spl id: 40b8f3ae-f0b1-deb3-e063-6294a90a1fec
spl set id: a8c08532-1169-6603-e053-2a95a90a3484

Reported adverse events (FAERS/openFDA)#

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