FDA.reportPublic FDA data

Giltuss Severe Sinus Nasal Spray

Manufacturer
Gil Pharmaceutical Corp | SEAWAY PHARMA
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:38:37

Label at a glance#

ProductGiltuss Severe Sinus
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure10 sections

Storage and handling

Other information store between 20° to 25°C (68° to 77° F) retain carton for future reference on full labeling

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Oxymetazoline HCl 0.05%

OTC - PURPOSE SECTION

Purpose

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses
temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
  • temporarily relive sinus congestion and pressure
  • shrinks swollen nasal membrances so you can breathe more freely

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed
  • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection

OTC - STOP USE SECTION

Stop use and ask a doctor ifsymptoms persist

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.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostrill. Not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age:ask a doctor.
  • Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle.

STORAGE AND HANDLING SECTION

Other information

  • store between 20° to 25°C (68° to 77° F)
  • retain carton for future reference on full labeling

INACTIVE INGREDIENT SECTION

Inactive Ingredients

benzalkonium chloride, dibasic sodium phosphate, edetate disodium dihydrate, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, povidone, purified water.

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

FAST AND POWERFUL

Giltuss®

SEVERE SINUS

UP TO 12 HOURS RELIEF

EXTRA MOISTURIZING

FAST RELIEF OF:

  • SINUS CONGESTION AND PRESSURE
  • STUFFY NOSE

PUMP MIST

0.5 FL OZ (15 mL)

Severe Sinus 6-25-2020Severe Sinus 6-25-2020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN6
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD6
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58552-142-152022-01-31C16284748780-1d6a99b39-5e36-a426-e053-dadaa90af4c2Giltuss Severe Sinus Nasal Spray
58552-142-152022-01-31C16284748780-1d6a99b39-5e36-a426-e053-dadaa90af4c2Giltuss Severe Sinus Nasal Spray
58552-142-152022-01-28C16284748780-1d6a99b39-5e36-a426-e053-dadaa90af4c2Giltuss Severe Sinus Nasal Spray
58552-142-152022-01-28C16284748780-1d6a99b39-5e36-a426-e053-dadaa90af4c2Giltuss Severe Sinus Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-142-15Giltuss Severe Sinus1 in 1 CARTONSPRAY16
58552-142-15Giltuss Severe Sinus15 mL in 1 BOTTLE, SPRAYSPRAY156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-142-15ML - Milliliter58552-1423cbe8963-a575-45bf-98a0-e85fd6974b7012021-01-08

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
58552-14258552-142-15

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-24full-release2026-06-01 00:29:57

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 Severe SinusOXYMETAZOLINE HCLGil Pharmaceutical Corpab7fae3b-1f7d-5d0f-e053-2a95a90a148e2025-10-09WarningsExact identifier
ndc (package): 58552-142-15
ndc (product): 58552-142
ndc11 (package): 58552014215
spl id: 40b8f0e4-90a0-f6b2-e063-6394a90a083b
spl set id: ab7fae3b-1f7d-5d0f-e053-2a95a90a148e

Reported adverse events (FAERS/openFDA)#

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