Sinosil
FDA Label NDC 44237-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Herbion Pakistan Pvt Ltd for the product Sinosil (NDC 44237-007). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Xylometazoline HCl 0.1%

Otc - Purpose

Nasal Decongestant

Indications & Usage

Temporarily relieves nasal congestion due to cold, hay fever or other respiratory allergies.

Warnings

Do not exceed recommended dose.

Otc - Ask Doctor

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Otc - When Using

When using this product

  • Do not use this product for more than 3 days.  Use only as directed.  Frequent or prolonged use may cause nasal congestion to recur or worsen.  If symptoms persist, consult a doctor.
  • 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.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, consult your physician before using.

Otc - 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.

Dosage & Administration

Adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more often than every 8 to 10 hours.  Do not give to children under 12 years of age unless directed by a doctor.

Storage And Handling

Store at 20-25 degrees C (68-77 degrees F)

Inactive Ingredient

Disodium edetate, Di-sodium hydrogen phosphate, D.I. Water, Sodium Chloride, Sodium di-hydrogen phosphate, thiomersal

Otc - Questions

Questions or comments?

1-888-654-3724, Monday through Friday, 9am-5pm or www.herbion.com

Package Label.Principal Display Panel

Nasal Decongestant Spray

For temporary decongestion of the nasal mucosa

* Please review the disclaimer below.