FDA Label for Tukol Max Action
View Indications, Usage & Precautions
Tukol Max Action Product Label
The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient................................................. Purpose
Oxymetazoline hydrochloride 0.05%.....................Nasal decongestant
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
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