TUKOL MAX ACTION- oxymetazoline hcl spray

Tukol Max Action by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient................................................. Purpose

Oxymetazoline hydrochloride 0.05%.....................Nasal decongestant

PURPOSE

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

WARNINGS

Warnings

Ask a doctor before use if you have heart disease

high blood pressure thyroid disease diabetes

trouble urinating due to an enlarged prostrate gland

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 dischare may occur

• use of this container by more than one person may spread

infection

STOP USE

Stop use and ask a doctor if symptoms persist.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional

before use.

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.

INDICATIONS & USAGE

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.

STORAGE AND HANDLING

Other information store at room temperature 20-25ºC

(68-77ºF) keep carton for full labeling

INACTIVE INGREDIENT

Inactive ingredients benzalkonium chloride, benzyl

alcohol, edetate disodium, polyethylene glycol 1500, povidone

k30, purified water, sodium phosphate dibasic, sodium

phosphate monobasic monohydrate

DOSAGE & ADMINISTRATION

Made in China

Distributed by: Genomma Lab USA Inc.,

Houston, TX 77027

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TUKOL MAX ACTION 
oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-913
Route of Administration	NASAL

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
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POVIDONE K30 (UNII: U725QWY32X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-913-05	1 in 1 CARTON	05/06/2021
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 Drug	M012	05/06/2021

Labeler - GENOMMA LAB USA, INC. (832323534)