Equaline
FDA Label NDC 41163-728

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Supervalu Inc. for the product Equaline (NDC 41163-728). 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

for the temporary relief of 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 exceed recommended dosage

• do not use for more than 3 days. Use only as directed

• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

• the use of this container by more than one person may spread infection

• frequent or prolonged use may cause nasal congestion to recur or worsen

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

  • adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more 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 between 20°-25°C (68°-77°F)
  • container is filled to proper level for best spray action

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, citric acid, purified water, sodium chloride, sodium citrate

Questions

1-877-932-7948

Important: Keep This Carton For Future Reference On Full Labeling

DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

Distributed By: Supervalu Inc.
Eden Prairie, MN 55344

This product is not manufactured or distributed by Novartis Consumer Health Inc., the owner of the registered trademark 4-Way Fast Acting Nasal Spray.

Principal Display

NDC 41163-728-01

Equaline

Fast Acting

Nasal Spray

Phenylephrine hydrochloride 1%

(nasal decongestant)

fast acting relief of

  • nasal congestion
  • sinus congestion
  • sinus pressure
  • swollen nasal passages

    • 1 FL OZ (30mL)

* Please review the disclaimer below.