GILTUSS SEVERE SINUS- oxymetazoline hcl spray 
Gil Pharmaceutical Corp

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Giltuss Severe Sinus Nasal Spray

Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses
temporarily relieves nasal congestion due to:

Warnings

Ask a doctor before use if you have

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

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

Stop use and ask a doctor ifsymptoms persist

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive Ingredients

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

Tamper evident: do not use if safety seal is broken or missing

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

FAST AND POWERFUL

Giltuss®

SEVERE SINUS

UP TO 12 HOURS RELIEF

EXTRA MOISTURIZING

FAST RELIEF OF:

PUMP MIST

0.5 FL OZ (15 mL)

Severe Sinus 6-25-2020

GILTUSS SEVERE SINUS 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-142
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-142-151 in 1 CARTON07/28/2020
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/28/2020
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
SEAWAY PHARMA117218785manufacture(58552-142)

Revised: 10/2023
Document Id: 0875ab1f-0e03-fd9d-e063-6394a90a6e04
Set id: ab7fae3b-1f7d-5d0f-e053-2a95a90a148e
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp