Quality Choice Solution/ Drops
FDA Label NDC 63868-697

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Quality Choice (NDC 63868-697). 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 temporarily relief 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 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).

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

Questions Or Comments?

1-866-467-2748

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.

* Please review the disclaimer below.