TUKOL MAX ACTION- oxymetazoline hydrochloride liquid

Tukol Max Action by

Drug Labeling and Warnings

Tukol Max Action by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies.
  • Shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

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

When using this product

• do not use more than directed
• do not use more than 3 days. 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 if symptoms 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

• adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period
• shake well before use. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.
• children under 6 years of age: ask a doctor

Other information

• store between 20° and 25°C (68° and 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?

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

SPL UNCLASSIFIED SECTION

Distributed by
Genomma Lab USA Inc.,
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton

NEW

Tukol®
MAX ACTION

NASAL SPRAY
Spray Nasal

Oxymetazoline HCl-Nasal Decongestant

Adults

12
Hour Relief

• FAST, POWERFUL
  CONGESTION RELIEF

Pump Mist Anti-Drip

0.5 FL OZ (15ML)

INGREDIENTS AND APPEARANCE

TUKOL MAX ACTION 
oxymetazoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
oxymetazoline hydrochloride (UNII: K89MJ0S5VY) (oxymetazoline - UNII:8VLN5B44ZY)	oxymetazoline hydrochloride	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride (UNII: F5UM2KM3W7)
Water (UNII: 059QF0KO0R)
Benzyl alcohol (UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
Edetate disodium (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-307-05	1 in 1 CARTON	07/22/2021
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/22/2021

Labeler - Genomma Lab USA (832323534)