Otc - Active Ingredient
Active Ingredient................................................. Purpose
Oxymetazoline hydrochloride 0.05%.....................Nasal decongestant
Tukol Max Action
FDA Label NDC 50066-913
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa, Inc. for the product Tukol Max Action (NDC 50066-913). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- temporarily relieves nasal congestion due to:
- temporarily relieves sinus congestion and pressure
- shrinks swollen nasal membranes so you can breathe more freely
• common cold • hay fever • upper respiratory allergies
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
Otc - When Using
When using this product
- do not use more than directed
- do not use for more than 3 days. Use only as directed.
- temporary discomfort such as burning, stinging, sneezing, or
- use of this container by more than one person may spread
Frequent or prolonged use may cause nasal congestion to
recur or worsen.
an increase in nasal dischare may occur
infection
Otc - Stop Use
Stop use and ask a doctor if symptoms persist.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional
before use.
Otc - 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 20-25°C
(68-77°F) • 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
* Please review the disclaimer below.
