Tukol Max Action Nasal Spray 0.5 oz, ZDP, 2021

Manufacturer
GENOMMA LAB USA, INC.
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:16

Label at a glance#

ProductTukol Max Action
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure12 sections

Storage and handling

Other information • store at room temperature 20-25ºC (68-77ºF) • keep carton for full labeling

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

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

OTC - PURPOSE SECTION

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 SECTION

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

OTC - WHEN USING SECTION

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

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.

INDICATIONS & USAGE SECTION

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 SECTION

Other information • store at room temperature 20-25ºC

(68-77ºF) • keep carton for full labeling

INACTIVE INGREDIENT SECTION

Inactive ingredients benzalkonium chloride, benzyl

alcohol, edetate disodium, polyethylene glycol 1500, povidone

k30, purified water, sodium phosphate dibasic, sodium

phosphate monobasic monohydrate

DOSAGE & ADMINISTRATION SECTION

Made in China

Distributed by: Genomma Lab USA Inc.,

Houston, TX 77027

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59135913

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN2
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD2
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY2

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
50066-913-052025-01-30C16284748780-12cef2736-acd0-d83d-e063-dadaa90ab31fTukol Max Action Nasal Spray 0.5 oz, ZDP, 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-913-05Tukol Max Action15 mL in 1 BOTTLE, SPRAYSPRAY152
50066-913-05Tukol Max Action1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-913TUKOL MAX ACTION (OXYMETAZOLINE HCL) SPRAY [GENOMMA LAB USA, INC.]2Legacy NDC, 2 package rows20231214_c1b2c7a7-5873-62d7-e053-2995a90a7811.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-91350066-913-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
0c6c9b0d-57e5-89db-e063-6294a90ac1fec1b2c7a7-5873-62d7-e053-2995a90a78112023-12-13WarningsExact identifier
spl id: 0c6c9b0d-57e5-89db-e063-6294a90ac1fe
spl set id: c1b2c7a7-5873-62d7-e053-2995a90a7811

Reported adverse events (FAERS/openFDA)#

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