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Drug Facts
Tamper evident: do not use if safety seal is broken or missing
MANUFACTURED FOR GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
Giltuss Severe Sinus Spray
FDA Label NDC 58552-142
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gil Pharmaceutical Corp for the product Giltuss Severe Sinus (NDC 58552-142). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Oxymetazoline HCl 0.05%
Otc - Purpose
Purpose
Nasal decongestant
Indications & Usage
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
Warnings
Otc - Ask Doctor
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
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
Stop use and ask a doctor if symptoms persist
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
Other information
- store between 20° to 25°C (68° to 77° F)
- retain carton for future reference on full labeling
Inactive Ingredient
Inactive Ingredients
benzalkonium chloride, dibasic sodium phosphate, edetate disodium dihydrate, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, povidone, purified water.
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)
* Please review the disclaimer below.
