Topcare Nasal Four Spray
FDA Label NDC 36800-648

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Nasal Four (NDC 36800-648). 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

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies

Ask A Doctor Before Use If You Have

  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • 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. Frequent or prolonged use may cause nasal congestion to come back or get worse.
  • use only as directed
  • 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 and over: 2 or 3 sprays in each nostril not more often than every 4 hours
  • children under 12 years: 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 20°-25°C (68°-77°F)

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, boric acid, purified water, sodium borate

Questions Or Comments?

1-888-423-0139

Principal Display Panel

FAST ACTING

Nasal Four

Nasal Spray

PHENYLEPHRINE HYDROCHLORIDE 1%

NASAL DECONGESTANT

Fast Relief of:

Nasal congestion

Swollen nasal membranes

Sinus congestion

Sinus pressure

COMPARE TO 4-WAY® FAST ACTING NASAL SPRAY active ingredient

1 FL OZ (30 mL)

* Please review the disclaimer below.