Major Nasal Decongestant Spray
FDA Label NDC 0904-7435

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Major Nasal Decongestant (NDC 0904-7435). 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 active ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Oxymetazoline HCL 0.05%

Purpose

Nasal Decongestant

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely

Warnings

Ask A Doctor Before Use If You Have

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

When Using This Product

Do not use more than directed
  • do not use for more than three 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 discharge may occur.
  • use of this container by more than one person may spread infection.

Stop Use And Ask A Doctor If

Symptoms persist

Keep Out Of The Reach Of Children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 6 to under 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 consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Other Information

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

Inactive Ingredients

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Principal Display Panel

Major© Original Nasal Spray NDC 0904-7435-35
Oxymetazoline Hydrochloride 0.05%
12 hour Nasal Mist Nasal Decongestant
1/2 FLOZ (15ML)

760100_15ml_frontlabel (760100 15ml Frontlabel)

760100_15ml_frontlabel (760100 15ml Frontlabel)

7496599_15ml_carton (7496599 15ml Carton)

7496599_15ml_carton (7496599 15ml Carton)

760101_15ml_backlabel (760101 15ml Backlabel)

760101_15ml_backlabel (760101 15ml Backlabel)

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