Signature Care ™

Signature Care ™
SPL v7
SPL
SPL Set ID aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1
Route
NASAL
Published
Effective Date 2025-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (1 g)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Anhydrous Citric Acid Water Sodium Chloride Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-17

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
Directions
  • adults and children 12 years of age & over: 2 or 3sprays 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.
Active Ingredient

Phenylephrine hydrochloride 1%

Other Information
  • store at room Temperature
Inactive Ingredients

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

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Compare to the active ingredient in 4-Way Fast Acting Nasal Spray *

NDC 21130-728-30

Signature Care

Quality Guaranteed

Nasal Spray

Nasal Decongestant

Phenylephrine Hydrochloride

Fast acting relief of:

  • Nasal congestion
  • Sinus congestion
  • Sinus pressure
  • Swollen nasal membranes

1 FL OZ (30mL)

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

Distributed By

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of 4-Way ®Fast acting Nasal Spray.

When Using This Product
  • do not exceed recommended dosage
  • do not use 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
  • the 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 at 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

Structured Label Content

Uses

for the temporary relief of nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
Purpose

Nasal decongestant

Directions
  • adults and children 12 years of age & over: 2 or 3sprays 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.
Active Ingredient (Active ingredient)

Phenylephrine hydrochloride 1%

Other Information (Other information)
  • store at room Temperature
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

Compare to the active ingredient in 4-Way Fast Acting Nasal Spray *

NDC 21130-728-30

Signature Care

Quality Guaranteed

Nasal Spray

Nasal Decongestant

Phenylephrine Hydrochloride

Fast acting relief of:

  • Nasal congestion
  • Sinus congestion
  • Sinus pressure
  • Swollen nasal membranes

1 FL OZ (30mL)

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

Distributed By

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of 4-Way ®Fast acting Nasal Spray.

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

Advanced Ingredient Data


Raw Label Data

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