Giltuss Severe Sinus Nasal Spray

Giltuss Severe Sinus Nasal Spray
SPL v6
SPL
SPL Set ID ab7fae3b-1f7d-5d0f-e053-2a95a90a148e
Route
NASAL
Published
Effective Date 2020-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Glycerin Benzalkonium Chloride Edetate Disodium Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-28

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and 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
Dosage and 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.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store between 20° to 25°C (68° to 77° F)
  • retain carton for future reference on full labeling
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor ifsymptoms persist

Section 50567-7

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
Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 51727-6

Inactive Ingredients

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

Section 51945-4

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)

Section 53414-9

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

Section 55105-1

Purpose

Nasal decongestant

Section 55106-9

Active ingredient

Oxymetazoline HCl 0.05%


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store between 20° to 25°C (68° to 77° F)
  • retain carton for future reference on full labeling
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsymptoms persist

Section 50567-7 (50567-7)

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
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 51727-6 (51727-6)

Inactive Ingredients

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

Section 51945-4 (51945-4)

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)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredient

Oxymetazoline HCl 0.05%


Advanced Ingredient Data


Raw Label Data

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