FDA.reportPublic FDA data

Giltuss Childrens Cough and Chest Congestion

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 01:38:35

Label at a glance#

ProductGiltuss Childrens Cough and Chest Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

OTC - PURPOSE SECTION

Purposes

Cough Suppressant

Expectorant

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not useif your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma

OTC - STOP USE SECTION

Stop use and ask a doctor or pharmacist if the child has

  • symptoms do not get better within 7 days or are accompanied by fever
  • cough comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed.

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 dosing cup for use with this product
  • mL = milliliters
children under 2 yearsConsult a doctor
children 2 to under 6 years of age2.5 mL every 4 hours
children 6 to under 12 years of age5 mL every 4 hours
children 12 years and over10 mL every 4 hours

SPL UNCLASSIFIED 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, flavor, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's

GILTUSS®

COUGH & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

Non-Drowsy. Alcohol Free

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

RASPBERRY FLAVOR

4FL OZ (118 mL)

58552-133 Child CoughChestCongestion58552-133 Child CoughChestCongestion

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
58552-133-042022-01-31C16284748780-1d6a99b39-8480-a426-e053-dadaa90af4c2Giltuss Children's Cough & Chest Congestion
58552-133-042022-01-31C16284748780-1d6a99b39-8480-a426-e053-dadaa90af4c2Giltuss Children's Cough & Chest Congestion
58552-133-042022-01-28C16284748780-1d6a99b39-8480-a426-e053-dadaa90af4c2Giltuss Children's Cough & Chest Congestion
58552-133-042022-01-28C16284748780-1d6a99b39-8480-a426-e053-dadaa90af4c2Giltuss Children's Cough & Chest Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-133-04Giltuss Childrens Cough and Chest Congestion1 in 1 CARTONSOLUTION16
58552-133-04Giltuss Childrens Cough and Chest Congestion118 mL in 1 BOTTLESOLUTION1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-133-04ML - Milliliter58552-1339135f187-4152-4bbd-a51b-c92eddeb35a312019-04-11

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
58552-13358552-133-04

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
D&C RED NO. 339DBA0SBB0LIACT
WATER059QF0KO0RIACT
SUCROSEC151H8M554IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

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 Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852d5f01-9289-5515-e053-2a91aa0acf322025-10-09WarningsExact identifier
ndc (package): 58552-133-04
ndc (product): 58552-133
ndc11 (package): 58552013304
spl id: 40b83871-7eac-3d44-e063-6394a90a2b29
spl set id: 852d5f01-9289-5515-e053-2a91aa0acf32

Reported adverse events (FAERS/openFDA)#

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