Nasal Spray
FDA Label NDC 41250-989

13 label sections · Submitted to the FDA by Meijer Distribution Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Nasal (NDC 41250-989). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast feeding,, 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

Active Ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves

  • nasal congestion due to a cold, hay fever, or other upper respiratory allergies
  • sinus congestion and pressure

Ask A Doctor Before Use If You Have

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

When Using This Product

  • do not exceed recommended dosage
  • do not use this product 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 discharge may occur
  • use of this container by more than one person may spread infection

Stop Use And Ask A Doctor If

  • symptoms persist

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply. Secure cap after use.

adults & children 6 yrs. & older (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 24 hours.

children 2 to under 6 yrs

ask a doctor

children under 2 yrs

do not use

Other Information

  • store at 20-25°C (68-77°F)

Inactive Ingredients

benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

Meijer®

MAXIMUM STRENGTH

Nasal Spray

COMPARE TO SINEX® SEVERE ACTIVE INGREDIENT

Oxymetazoline HCl

Nasal Decongestant

12 HOUR

WITH MENTHOL

SEVERE

Ultra Fine Mist

Fast & Powerful Relief

Sinus Congestion & Pressure

1 FL OZ (30 mL)

Nasal Spray Carton (7x0106ec2)

Nasal Spray Carton (7x0106ec2)

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