Tukol®

Tukol®
SPL v1
SPL
SPL Set ID 73358103-43dc-4b11-9c89-9a6ba45bf1af
Route
TOPICAL
Published
Effective Date 2025-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 mg)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate, Monobasic, Anhydrous Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-12

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely
Section 42229-5

Drug Facts

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 if symptoms persist.

Section 53414-9

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

Directions
  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril 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: consult a doctor
  • shake well before use. Remove safety seal. 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, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap onto bottle.
Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store at room temperature 20-25°C (68-77°F)
  • keep carton for full labeling
Inactive Ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol 1500, povidone k30, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate

Questions Or Comments?

Call weekdays 8 AM to 6 PM EST at 1-877-994-3666

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
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 15 Ml Bottle Carton

NEW

Tukol®

MAX ACTION

NASAL SPRAY

Oxymetazoline HCl-Nasal Decongestant

Adults

12 Hour Relief

CHILD SAFETY CAP

FAST, POWERFUL

CONGESTION RELIEF

Pump Mist Anti-Drip

0.5 FL OZ (15ML)


Structured Label Content

Uses
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely
Section 42229-5 (42229-5)

Drug Facts

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 if symptoms persist.

Section 53414-9 (53414-9)

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

Purpose

Nasal decongestant

Directions
  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril 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: consult a doctor
  • shake well before use. Remove safety seal. 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, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap onto bottle.
Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store at room temperature 20-25°C (68-77°F)
  • keep carton for full labeling
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol 1500, povidone k30, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate

Questions Or Comments? (Questions or comments?)

Call weekdays 8 AM to 6 PM EST at 1-877-994-3666

When Using This Product (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
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 15 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton)

NEW

Tukol®

MAX ACTION

NASAL SPRAY

Oxymetazoline HCl-Nasal Decongestant

Adults

12 Hour Relief

CHILD SAFETY CAP

FAST, POWERFUL

CONGESTION RELIEF

Pump Mist Anti-Drip

0.5 FL OZ (15ML)


Advanced Ingredient Data


Raw Label Data

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