Careone Fast Acting Nasal Spray
FDA Label NDC 41520-729

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Careone Fast Acting Nasal (NDC 41520-729). 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?

1-800-719-9260

Principal Display Panel

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

FAST ACTING NASAL SPRAY

Phenylephrine Hydrochloride 1 %

Nasal Decongestant

4hr

Relieves:

Nasal Congestion

Swollen Nasal Membranes

Sinus Congestion

Sinus Pressure

Gluten Free

OUR PHARMACISTS RECOMMEND

1 FL OZ (30mL)

648d4of-fast-acting-nasal-spray.jpg (648d4of Fast Acting Nasal Spray)

648d4of-fast-acting-nasal-spray.jpg (648d4of Fast Acting Nasal Spray)

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