Nasalub Nasal Relief
FDA Label NDC 50066-065

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 Nasalub Nasal Relief (NDC 50066-065). 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 - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                 Purpose

Oxymetazoline HCL 0.05%................................... Nasal decongestant

Otc - Purpose

Uses

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

Warnings

Warnings

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - When Using

When using this product

  • do not use more directed. 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 icrease 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.

Indications & Usage

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
  • children under 6 years of age: ask a doctor
  • shake well before use. To open, rotate cap to align the marks. squeeze cap on both sides in a counterclockwise 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 tiliting the head, insert nozzle into nostril. Fully depress rim with a firm, een stroke and sniff deeply. Wipe nozzle clean after each use and sanp cab back onto the bottle.

Storage And Handling

Other information

  • store between 20° and 25°C (68° and 77°F)
  • retain carton for future reference on full labeling

Inactive Ingredient

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phospahte hydrate, disodium EDTA, distilled water, monobasic sodium phosphate dihydrate, PEG 1450, PVP K30

Dosage & Administration

DISTRIBUTED BY:

GENOMMA LAB USA INC.

HOUSTON, TX 77027

MADE IN KOREA

Package Label.Principal Display Panel

Image Description (50066)

Image Description (50066)

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