Tukol Max Action
FDA Label NDC 50066-307

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 for the product Tukol Max Action (NDC 50066-307). 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 other, active ingredient, purpose, uses, ask a doctor before use if you have, when using this product, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by
Genomma Lab USA Inc.,
Houston, TX 77027

Active Ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

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

Ask A Doctor Before Use If You Have

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

When Using This Product

  • 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

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.

Directions

  • 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

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

Inactive Ingredients

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

Questions?

Call weekdays from 8 AM to 6 PM EST at 1-877-994-3666

Principal Display Panel - 15 Ml Bottle Carton

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)

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