Tukol ® Max Action Nasal Spray

Manufacturer
Genomma Lab USA
Effective date
2021-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:38

Label at a glance#

ProductTukol Max Action
Active ingredientoxymetazoline hydrochloride
Label structure11 sections

Indications and uses

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

Dosage and administration

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 af...

Storage and handling

store between 20° and 25°C (68° and 77°F) keep carton for full labeling

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline HCl 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • store between 20° and 25°C (68° and 77°F)
  • keep carton for full labeling

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol 1500, povidone K30, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton
PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN1
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD1
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-307-052025-01-30C16284748780-12cef2736-b420-d83d-e063-dadaa90ab31fTukol ® Max Action Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-307-05Tukol Max Action1 in 1 CARTONLIQUID11
50066-307-05Tukol Max Action15 mL in 1 BOTTLE, SPRAYLIQUID151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-307TUKOL MAX ACTION (OXYMETAZOLINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA]1Legacy NDC, 2 package rows20210724_715657cb-dcc0-4a97-adeb-46d04cd10742.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-30750066-307-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
61319534-9c6b-45eb-bb07-f495f97ae3d7715657cb-dcc0-4a97-adeb-46d04cd107422021-07-22WarningsExact identifier
spl id: 61319534-9c6b-45eb-bb07-f495f97ae3d7
spl set id: 715657cb-dcc0-4a97-adeb-46d04cd10742

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.