4 Way Spray
FDA Label NDC 0067-2086

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product 4 Way (NDC 0067-2086). 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

Phenylephrine Hydrochloride 1%

Purpose

Nasal Decongestant

Uses

temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies

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
  • 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
  • infection may spread if this container is used by more than one person

Stop Use And Ask A Doctor If

symptoms persist

If Pregnant Or Breast-Feeding,

ask a health care professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more often than every 4 hours
  • children under 12 years of age: ask a doctor
  • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other Information

  • store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

benzalkonium chloride solution, boric acid, purified water, sodium borate

Questions Or Comments?

1-855-221-5428

Principal Display

NDC 0067-2086-01

4 way
Fast Acting
Phenylephrine Hydrochloride 1%

Nasal Decongestant

Fast Relief of:

  • 1.Nasal Congestion
  • 2.Swollen Nasal Membranes
  • 3.Sinus Congestion
  • 4.Sinus Pressure

    • Nasal Spray

    1 fl oz (29.6 mL)

    DO NOT USE IF PERFORATED OVERWRAP PRINTED WITH GSK
    LOGO AROUND THE CAP OR BOTTLE IS BROKEN OR MISSING

    1-855-221-5428

    Trademarks are owned by or licensed to the GSK group of companies.

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    ©2017 GSK group of companies or its licensor.

    13183

    Made in Canada

* Please review the disclaimer below.