FDA.reportPublic FDA data

Giltuss Diabetic

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 01:38:34

Label at a glance#

ProductGiltuss Diabetic Cough and Cold
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Storage and handling

Other information store at room temperature, between 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 ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin 200 mg

OTC - PURPOSE SECTION

Purposes

Cough Suppressant

Expectorant

INDICATIONS & USAGE SECTION

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
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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 MAOl drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

OTC - WHEN USING SECTION

When using this product do not use more than directed

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 if

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts as 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 accidental overdose, get medical or professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 6 doses in any 24-hour period
  • keep dosing cup with 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 2 to under 6 years of age2.5 mL every 4 hours
children under 2 years of ageDo not use

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients:Citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water and 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

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

OTHER SAFETY INFORMATION

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

PERSONS WITH DIABETES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING ANY MEDICATION OR DIETARY SUPPLEMENT

THIS PRODUCT DOES NOT CONTAIN ANY MEDICATION TO IMPROVE OR RELIEVE DIABETES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Giltuss® DIABETIC

COUGH & COLD

RELIEVES

  • COUGH AND COLD
  • CHEST CONGESTION
  • LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

SAFE FOR PEOPLE WITH DIABETES

GRAPE FLAVOR

4 FL OZ (118 mL)

58552-13458552-134

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN6
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD6
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY6
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY6
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58552-134-042022-01-31C16284748780-1d6a99b39-d1d0-a426-e053-dadaa90af4c2Giltuss Diabetic Cough and Cold
58552-134-042022-01-31C16284748780-1d6a99b39-d1d0-a426-e053-dadaa90af4c2Giltuss Diabetic Cough and Cold
58552-134-042022-01-28C16284748780-1d6a99b39-d1d0-a426-e053-dadaa90af4c2Giltuss Diabetic Cough and Cold
58552-134-042022-01-28C16284748780-1d6a99b39-d1d0-a426-e053-dadaa90af4c2Giltuss Diabetic Cough and Cold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-134-04Giltuss DiabeticCough and Cold1 in 1 CARTONSOLUTION16
58552-134-04Giltuss DiabeticCough and Cold118 mL in 1 BOTTLESOLUTION1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-134-04ML - Milliliter58552-13493286ab8-f22b-4481-9462-009f5cd85e6812019-05-02

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-13458552-134-04

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
PROPYLPARABENZ8IX2SC1OHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
METHYLPARABENA2I8C7HI9TIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCRALOSE96K6UQ3ZD4IACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-24full-release2026-06-01 00:29:54

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 Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp85183b38-ce2a-0e0e-e053-2991aa0a336f2025-10-09WarningsExact identifier
ndc (package): 58552-134-04
ndc (product): 58552-134
ndc11 (package): 58552013404
spl id: 40b857bd-5180-046f-e063-6294a90a7252
spl set id: 85183b38-ce2a-0e0e-e053-2991aa0a336f

Reported adverse events (FAERS/openFDA)#

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