quality choice nasal spray phenylephrine hcl drug facts

quality choice nasal spray phenylephrine hcl drug facts
SPL v6
SPL
SPL Set ID a12e2e66-d2f3-47a6-a915-a309ae828d27
Route
nasal
Published
Effective Date 2018-01-31
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

Marketing Status
otc monograph drug active Since 2018-12-18

Purpose

Nasal decongestant

Description

Phenylephrine hydrochloride 1%


Medication Information

Uses

for the temporarily relief nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
Purpose

Nasal decongestant

Directions
  • adults and children 12 years of age and older:2 or 3 drops 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 room temperature
  • container is filled to proper level for best spray action.
Inactive Ingredients

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

Description

Phenylephrine hydrochloride 1%

Principal Display Panel

NDC# 63868-697-30

*Compare to Active Ingredient in 4-Way ®Fast Acting Nasal Spray

Nasal Spray

Nasal Decongestant

PHENYLEPHRINE HCl 1%

For Relief of:

Nasal Congestion

Sinus Congestion

Sinus Pressure

Swollen Nasal Membranes

100% QC SATISFACTION GUARANTEED

1 FL OZ (30 mL)

Distributed by: C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

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

Active Ingredient

Phenylephrine hydrochloride 1%

Questions Or Comments?

1-866-467-2748

When Using This Product
  • do not use more than directed
  • 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
  • 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).

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 temporarily relief nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
Purpose

Nasal decongestant

Directions
  • adults and children 12 years of age and older:2 or 3 drops 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 (Other information)
  • store at room temperature
  • container is filled to proper level for best spray action.
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

NDC# 63868-697-30

*Compare to Active Ingredient in 4-Way ®Fast Acting Nasal Spray

Nasal Spray

Nasal Decongestant

PHENYLEPHRINE HCl 1%

For Relief of:

Nasal Congestion

Sinus Congestion

Sinus Pressure

Swollen Nasal Membranes

100% QC SATISFACTION GUARANTEED

1 FL OZ (30 mL)

Distributed by: C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

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

Active Ingredient (Active ingredient)

Phenylephrine hydrochloride 1%

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)
  • do not use more than directed
  • 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
  • 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 (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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