TUKOL MAX ACTION- oxymetazoline hydrochloride liquid 
Genomma Lab USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Tukol® Max Action Nasal Spray

Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

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

Other information

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

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

Pump Mist Anti-Drip

0.5 FL OZ (15ML)

PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton
TUKOL MAX ACTION 
oxymetazoline hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-307
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
oxymetazoline hydrochloride (UNII: K89MJ0S5VY) (oxymetazoline - UNII:8VLN5B44ZY) oxymetazoline hydrochloride0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-307-051 in 1 CARTON07/22/2021
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/22/2021
Labeler - Genomma Lab USA (832323534)

Revised: 7/2021
Document Id: 61319534-9c6b-45eb-bb07-f495f97ae3d7
Set id: 715657cb-dcc0-4a97-adeb-46d04cd10742
Version: 1
Effective Time: 20210722
 
Genomma Lab USA