Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f0f547dd-892b-4f94-8c63-7f0b2470aa91
Route
NASAL
Published
Effective Date 2014-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Citric Acid Monohydrate Water Sodium Chloride Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-10-30

Description

Phenylephrine hydrochloride 1%

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine hydrochloride 1%

Uses

for the temporary relief of nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
Questions

1-877-932-7948

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.
Active Ingredient

Phenylephrine hydrochloride 1%

Other Information
  • store between 20°-25°C (68°-77°F)
  • container is filled to proper level for best spray action
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)

Inactive Ingredients

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

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)

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
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.


Structured Label Content

Uses

for the temporary relief of nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
Purpose

Nasal decongestant

Questions

1-877-932-7948

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.
Active Ingredient (Active ingredient)

Phenylephrine hydrochloride 1%

Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
  • container is filled to proper level for best spray action
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)

Inactive Ingredients

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

When Using This Product (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 (Stop use and ask a doctor if)

symptoms persist

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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 (1-800-222-1222)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Important: Keep This Carton for Future Reference On Full Labeling (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.


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