FDA.reportPublic FDA data

Giltuss Childrens Allergy Plus

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 Childrens Allergy Plus Cough and Congestion
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
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 ingredients (in each 5 mL)

Chlorpheniramine maleate USP, 2 mg

Dextromethorphan HBr USP, 10 mg

Phenylephrine HCl USP, 5 mg

OTC - PURPOSE SECTION

Purposes

Antihistamine

Cough Suppressant

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves
  • cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
  • nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily restores freer breathing through the nose

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • to sedate a child or to make a child sleepy
  • in a child who is 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is

  • taking sedatives or tranquilizers
  • taking any other oral nasal decongestant or stimulant

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed
  • may cause marked drowsiness
  • excitability may occur, especially in children

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • nervousness, dizzyness, or sleepless occurs
  • symptoms do not get better within 7 days or are accompanied by a fever
  • cough lasts 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 breastfeeding,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

  • not take more than 6 doses in any 24-hour period
  • use enclosed dosing cup
  • keep dosage cup for use with this product
  • mL=milliter
children under 6 yearsConsult a Doctor
children 6 to under 12 years5 mL every 4 to 6 hours
adults and children 12 years and over10 mL every 4 to 6 hours

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 ingredients

citric acid, flavor, glycerin, methylparaben, 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

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

Children's

Giltuss® ALLERGY PLUS COUGH & CONGESTION

ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT

Alcohol Free. Sodium Free. Sugar Free. Dye Free.

  • SNEEZING
  • RUNNY NOSE
  • COUGH
  • ITCHY & WATERY EYES
  • STUFFY NOSE
  • SINUS PRESSURE

TUTTI FRUTTI FLAVOR

4 FL OZ (118 mL)

58552-139 Child Allergy Cough Congestion58552-139 Child Allergy Cough Congestion

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN6
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD6
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58552-139-042022-01-31C16284748780-1d6a99b39-9e73-a426-e053-dadaa90af4c2Giltuss Children's Allergy Plus Cough & Congestion
58552-139-042022-01-31C16284748780-1d6a99b39-9e73-a426-e053-dadaa90af4c2Giltuss Children's Allergy Plus Cough & Congestion
58552-139-042022-01-28C16284748780-1d6a99b39-9e73-a426-e053-dadaa90af4c2Giltuss Children's Allergy Plus Cough & Congestion
58552-139-042022-01-28C16284748780-1d6a99b39-9e73-a426-e053-dadaa90af4c2Giltuss Children's Allergy Plus Cough & Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-139-04Giltuss Childrens Allergy PlusCough and Congestion118 mL in 1 BOTTLESOLUTION1186
58552-139-04Giltuss Childrens Allergy PlusCough and Congestion1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-139-04ML - Milliliter58552-13986157931-17f6-4e8e-8588-597a4e63697012019-05-02

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
58552-13958552-139-04

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
METHYLPARABENA2I8C7HI9TIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SUCRALOSE96K6UQ3ZD4IACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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 Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852c5a57-7ee4-3c5c-e053-2a91aa0a14332025-10-09WarningsExact identifier
ndc (package): 58552-139-04
ndc (product): 58552-139
ndc11 (package): 58552013904
spl id: 40b8adbf-d8c9-a01a-e063-6394a90a45ff
spl set id: 852c5a57-7ee4-3c5c-e053-2a91aa0a1433

Reported adverse events (FAERS/openFDA)#

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