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Tukol max action - Medication Information

Product NDC Code 50066-913
Drug Name

Tukol max action

Type Brand
Pharm Class Imidazolines [CS],
Increased Sympathetic Activity [PE],
Vasoconstriction [PE],
Vasoconstrictor [EPC]
Active Ingredients
Oxymetazoline hydrochloride .5 mg/ml
Route NASAL
Dosage Form SPRAY
RxCUI drug identifier 1000990
Application Number M012
Labeler Name GENOMMA LAB USA, INC.
Packages
Package NDC Code Description
50066-913-05 1 bottle, spray in 1 carton (50066-913-05) / 15 ml in 1 bottle, spray
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient ................................................. Purpose Oxymetazoline hydrochloride 0.05%.....................Nasal decongestant

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Made in China Distributed by: Genomma Lab USA Inc., Houston, TX 77027

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol 1500, povidone k30, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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.

Purpose

Information about the drug product’s indications for use.
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

Spl product data elements

Usually a list of ingredients in a drug product.
Tukol Max Action Oxymetazoline HCL OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE EDETATE DISODIUM POLYETHYLENE GLYCOL 1500 BENZYL ALCOHOL POVIDONE K30 BENZALKONIUM CHLORIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
5913

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if symptoms persist.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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

Pregnancy or breast feeding

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

Storage and handling

Information about safe storage and handling of the drug product.
Other information • store at room temperature 20-25ºC (68-77ºF) • keep carton for full labeling

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API