Giltuss D

Manufacturer
Dextrum Laboratories Inc.
Effective date
2025-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:16

Label at a glance#

ProductGiltuss D
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure15 sections

Dosage and administration

Directions, not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product, ml= mililiter Adults and children 12 years and over 10 ml every 4 hours Children 6 to under 12 years 5 ml every 4 hours Children under 6 years Consult a doctor

Label contents#

Full prescribing information#

Purposes

OTC - PURPOSE SECTION

UsesUsesPurposes

Antihistamine

Nasal decongestant

Uses

Temporary relieves these symptons due to hay fever ( allergy rhinitis) or other respiratory allergies:

runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of nose or throat, sinus congestion and pressure

Warnings

WARNINGS SECTION

Warnings:

Do not use to sedate a child or to make a child sleepy, if you ar etaking a prescription monoamine oxidase inhibitor ( MAOI) ( certains 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. WarningsWarnings

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

Heart desease, high blood pressure, thyroid desease, diabetes, trouble urinating due to enlarged prostate gland, glaucoma, a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or ephysema Ask a doctorAsk a doctor

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are, taking sedatives or tranquilizers Ask a doctor or pharmacistAsk a doctor or pharmacist

When using

OTC - WHEN USING SECTION

When using this product, do not use more than directed, may cause drowsiness, avoid alcoholic beverages, alcohol, sedatives, and tranquilizers may increase drowsiness, avoid alcoholic drinks, be careful when driving a motor vehicle or operating machinery, exitability may occur, especially in children. When usingWhen using

Pregnancy or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If Pregnancy or breast-feeding, ask a health professional before use. Keep out of reach of children. In case or overdose, get medical help or contact a Poisson Control Center right away ( 1-800-222-1222)

If pregnancyIf pregnancy

Stop use section

OTC - STOP USE SECTION

Stop use and ask a doctor if, if you get nervous, dizzy or sleepless, symptons do not get better witi

hin 7 days or are accompanied by fever Stop usingStop using

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsActive ingredientsChlorpheniramine maleate 3.5 mg

Phenilephryne HCl, 10 mg

Directions

DOSAGE & ADMINISTRATION SECTION

Directions, not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product, ml= mililiter

Adults and children 12 years and over 10 ml every 4 hours

Children 6 to under 12 years 5 ml every 4 hours

Children under 6 years Consult a doctor DirectionsDirections

Other information

OTHER SAFETY INFORMATION

Other information store at room temperature 15 - 30 oC (59-86 o F), close cap tightly, save carton for complete drug facts Other InformationOther Information

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified water, Sodium Carboxymethylcellulose, Sucralose. Inactive ingredientsInactive ingredients

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-787-848-9114 Monday-Friday 9AM-5PM EST, Call your doctor for medical advice in the event of side effects QustionsQustions

Indication and usage section

INDICATIONS & USAGE SECTION

Indication and usage section

Do not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product,

ml= mililiter

Adults and children 12 years and over 10 ml every 4 hours

Children 6 to under 12 years 5 ml every 4 hours

Children under 6 years Consult a doctor

indication an userindication an user

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep outKeep out

Keep out of reach of children.

In case or overdose, get medical help or contact a Poison Control Center right away ( 1-800-222-1222)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal panelPrincipal panelGiltuss D

Allergy & Congestion

Dye Free, preservative free, sodium free, sugar free

Sneezing, Runny Nose, Itchy & Water eyes, Itchy Throat or Nose, Sinus pressure, stuffy nose

Tutti Frutti Flavor

$ floz 118 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2724415chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG in 10 mL Oral SolutionPSN1
2724415chlorpheniramine maleate 0.35 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD1
2724415chlorpheniramine maleate 1.75 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY1
2724415chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - 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
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-010-04Giltuss D1 in 1 CARTONSYRUP11
65852-010-04Giltuss D118 mL in 1 BOTTLE, PLASTICSYRUP1181

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65852-01065852-010-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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 DGILTUSS DDextrum Laboratories Inc.3f17eefb-b625-b0f2-e063-6294a90afd4d2025-09-18WarningsExact identifier
ndc (package): 65852-010-04
ndc (product): 65852-010
ndc11 (package): 65852001004
spl id: 3f17eefb-b626-b0f2-e063-6294a90afd4d
spl set id: 3f17eefb-b625-b0f2-e063-6294a90afd4d

Reported adverse events (FAERS/openFDA)#

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