FDA.reportPublic FDA data

Giltuss D Allergy and Congestion

Manufacturer
Gil Pharmaceutical Corp
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:38:35

Label at a glance#

ProductGiltuss D Allergy and Congestion
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Storage and handling

Other information store at room temperature, USP do not use if blister seal is broken

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

Purposes
Antihistamine
Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses
Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

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

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever

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

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years and over

  • take 1 tablet every 4 hours
  • do not take more than 6 tablets in 24 hours
  • children 6 to under 12 years of age:take 1/2 tablet every 4 hours, not to exceed 3 tablets in a 24 hour period
  • do not use this product for children under 6 years of age

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature, USP
  • do not use if blister seal is broken

INACTIVE INGREDIENT SECTION

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose and Silica.

OTC - QUESTIONS SECTION

Questions? Call 787-848-9114

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

NO PSEUDOEPHEDRINE

Giltuss®-D

ALLERGY & CONGESTION

20 TABLETS

SUGAR FREE. ALCOHOL FREE. DYE FREE. SODIUM FREE

RELIEVES

  • SNEEZING
  • RUNNY NOSE
  • ITCHY, WATERY EYES
  • ITCHY THROAT OR NOSE
  • SINUS PRESSURE
  • STUFFY NOSE

58552-333 Giltuss D 1-16-201958552-333 Giltuss D 1-16-2019

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367227chlorpheniramine maleate 3.5 MG / phenylephrine HCl 10 MG Oral TabletPSN8
1367227chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD8

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
58552-333-20Giltuss D Allergy and Congestion2 in 1 POUCHTABLET28
58552-333-20Giltuss D Allergy and Congestion10 in 1 BOXTABLET108
58552-333-25Giltuss D Allergy and Congestion25 in 1 CARTONTABLET258
58552-333-25Giltuss D Allergy and Congestion1 in 1 POUCHTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-333-20EA - Each58552-3332fdb3b1d-25b1-4367-b6cb-538572f258de12019-04-11

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-33358552-333-20, 58552-333-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-03-10full-release2026-06-01 00:57:05

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 D Allergy and CongestionCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2ec-df65-e053-2a91aa0a42fb2025-10-09WarningsExact identifier
ndc (package): 58552-333-20
ndc (package): 58552-333-25
ndc (product): 58552-333
ndc11 (package): 58552033325
ndc11 (package): 58552033320
spl id: 40b9d721-f34a-2d28-e063-6294a90a5219
spl set id: 8591003c-c2ec-df65-e053-2a91aa0a42fb

Reported adverse events (FAERS/openFDA)#

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