NDC 44237-007 Sinosil Nasal Decongestant

NDC Product Code 44237-007

NDC 44237-007-15

Package Description: 15 mL in 1 BOTTLE, SPRAY

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Sinosil Nasal Decongestant with NDC 44237-007 is a product labeled by Herbion Pakistan Pvt Ltd. The generic name of Sinosil Nasal Decongestant is . The product's dosage form is and is administered via form.

Labeler Name: Herbion Pakistan Pvt Ltd

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • THIMEROSAL (UNII: 2225PI3MOV)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Herbion Pakistan Pvt Ltd
Labeler Code: 44237
Start Marketing Date: 02-09-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sinosil Nasal Decongestant Product Label Images

Sinosil Nasal Decongestant Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling 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 diseasehigh blood pressurethyroid diseasediabetesdifficulty in urination due to enlargement of the prostate gland

Otc - When Using

  • When using this productDo 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

* Please review the disclaimer below.