Giltuss Severe Sinus Nasal Spray

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:

PUMP MIST

0.5 FL OZ (15 mL)

• SINUS CONGESTION AND PRESSURE
• STUFFY NOSE