Sinufrin Plus Spray
FDA Label NDC 13709-232

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals, Inc. for the product Sinufrin Plus (NDC 13709-232). 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 ingredients, warnings, directions for dosing, uses, other information, otc - do not use, inactive ingredients, principle display, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

0.05% Oxymetazoline Hydrochloride

Warnings

  • Do not use this product for more than 3 consecutive days.Use only as directed.
  • Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
  • Do not use this product if you have heart disease, high blood pressure, thyroid disease or diabetes unless directed by a doctor.

    • KEEP OUT OF REACH OF CHILDREN. If Swallowed,get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if symptoms of nasal congestion persist after 3 days.

    Adult males with prostate disease, do not use this product.

    If pregnant or breast-feeding, ask health care professional before use.

    This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
    The use of this container by more than one person may spread infection.

Directions For Dosing

    * Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    * Children under 6 years of age: consult a doctor

Uses

Temporarily relieves nasal congestion due to common cold, sinus infections, hay fever, upper respiratory allergies.

temporarily relieves nasal congestion due to:

common cold

sinusitis

hay fever

upper respiratory allergies

Other Information

Store between 20 to 40 °C (68 to 104 °F)
Retain carton for future reference on full labeling


  • Keep head in an upright position for use.
  • Do not tilt head backward while spraying.
  •  Wipe nozzle clean after each use.

Otc - Do Not Use

Do not use this product for more than 3 consecutive days.

Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.

Inactive Ingredients

Propylene glycol, glycerin, sodium chloride, hyaluronic acid, aloe vera, allantoin, sodium bicarbonate USP, benzalkonium chloride, edetate disodium, purified water

Principle Display

Imag of Bottle

Image Of Bottle (Bottle)

Image Of Bottle (Bottle)

Box Label

Box Label (Box)

Box Label (Box)

* Please review the disclaimer below.