GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Xylometazoline Hydrochloride Nasal Drops 0.05%w/v (Pediatric)
B. Xylometazoline Hydrochloride Nasal Drops 0.1%w/v (Adult)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Xylometazoline Hydrochloride Nasal Drops 0.05%w/v
Composition:
Xylometazoline Hydrochloride USP……………………...0.05%w/v
Benzalkonium Chloride Solution USP…………………….0.02%v/v
(As preservative)
An Aqueous Isotonic Base………………………………………q.s.


B. Xylometazoline Hydrochloride Nasal Drops 0.1%w/v
Composition:
Xylometazoline Hydrochloride USP……………………...0.1%w/v
Benzalkonium Chloride Solution USP…………………….0.02%v/v
(As preservative)
An Aqueous Isotonic Base………………………………………q.s.

THERAPEUTIC INDICATIONS:

Xylometazoline Nasal Drops is used for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies.

DIRECTION OF USE:

1. Clear the nose by blowing gently.
2. Lie with head lower than shoulders.
3. Insert droppers pipette a little way into each nostril & apply 2-3 drops.
4. Remain still for few minutes.

CAUTION & WARNING:

CAUTION: To avoid contamination, do not keep part-used bottles of nose drops or nasal sprays to use later.
FOR NASAL USE ONLY.
SHAKE WELL BEFORE USE
Fast relief from blocked nose.
Throw away the container after each course of treatment.
KEEP MEDICINE OUT OF REACH OF CHILDREN
Read enclosed leaflet before use.
WARNING: 1. Do not touch the Nozzle tip as this may contaminate the solution.
2. Use the solution within one month. after opening the container.

STORAGE & DOSAGE:

Storage: Store in cool, dry place, away from direct heat and light.
Dosage: Children Over 2 years: 2-3 drops into each nostril per application, A total of 3-4 applications per day is usually sufficient.
Adults and children over 6 years: 2-3 drops into each nostril per application, A total of 3-4 applications per day is usually sufficient.
NOTE: Notrin adult Nasal Spray Delivers the medication in a fine mist to help clear congestion quickly and effectively.
- Provides relief in as little as 2 minutes
- Lasts up to 10 hours

Xylometazoline Hydrochloride Nasal Drops 0.05%w/v (Pediatric) Technical Specification:

Product Name:Xylometazoline Hydrochloride Nasal Drops 0.05%w/v
Brand Name:Notrin
Strength:Paediatric: 0.05%w/v,
Adult: 0.1%w/v
Dosage Form:Nasal Drops
Route of Administration:For intra nasal use only
Packing:10ml Bottle
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Decongestants, Vasoconstriction
Indication: Xylometazoline Nasal Drops is used to treat stuffy nose caused by allergies, sinus irritation, or the common cold.
Storage:Store in cool, dry place, away from direct heat and light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Xylometazoline Hydrochloride Nasal Drops 0.05%w/v (Pediatric)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Xylometazoline Hydrochloride Nasal Drops 0.05%w/v
    Composition:
    Xylometazoline Hydrochloride USP………………………0.05%w/v
    Benzalkonium Chloride Solution USP…………………….0.02%v/v
    (As preservative)
    An Aqueous Isotonic Base………………………………………q.s.

THERAPEUTIC INDICATIONS:

Xylometazoline Nasal Drops is used for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies.

DIRECTION OF USE:

  1. Clear the nose by blowing gently.
  2. Lie with head lower than shoulders.
  3. Insert droppers pipette a little way into each nostril & apply 2-3 drops.
  4. Remain still for few minutes.

CAUTION & WARNING:

CAUTION:  To avoid contamination, do not keep part-used bottles of nose drops or nasal sprays to use later.

FOR NASAL USE ONLY.

SHAKE WELL BEFORE USE

Fast relief from blocked nose.

Throw away the container after each course of treatment.

Keep medicine out of reach of children

Read enclosed leaflet before use.

WARNING:

  1. Do not touch the Nozzle tip as this may contaminate the solution.
  2. Use the solution within one month. after opening the container.

STORAGE & DOSAGE:

Storage: Store in cool, dry place, away from direct heat and light.

Dosage:
Children Over 2 years: 2-3 drops into each nostril per application, A total of 3-4 applications per day is usually sufficient.
Adults and children over 6 years: 2-3 drops into each nostril per application, A total of 3-4 applications per day is usually sufficient.

NOTE: Notrin adult Nasal Spray Delivers the medication in a fine mist to help clear congestion quickly and effectively.

  • Provides relief in as little as 2 minutes
  • Lasts up to 10 hours

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands out as a compelling choice for healthcare providers and patients seeking Xylometazoline Hydrochloride products due to several key factors. Firstly, the company’s unwavering commitment to maintaining high-quality standards in pharmaceutical manufacturing ensures that Xylometazoline Hydrochloride products meet stringent quality, efficacy, and safety requirements. This commitment instills confidence in healthcare providers and patients alike, assuring them of the medication’s reliability. With a rich history of experience in the pharmaceutical industry, Taj Pharmaceuticals brings invaluable expertise to the production and distribution of a wide range of pharmaceutical products. This expertise enhances the consistency and reliability of their pharmaceutical offerings, positioning them as a trusted and dependable supplier. Healthcare providers and patients can rely on the wealth of experience that Taj Pharmaceuticals brings to the table. Furthermore, Taj Pharmaceuticals places paramount importance on regulatory compliance, rigorously adhering to industry standards and implementing robust quality control procedures. This dedication ensures that Xylometazoline Hydrochloride products adhere to essential quality and safety requirements mandated by regulatory authorities. Healthcare providers can trust that the medication meets crucial regulations, underscoring the company’s commitment to patient safety.

Taj Pharmaceuticals’ global presence and well-established distribution network are pivotal in ensuring the widespread availability of Xylometazoline Hydrochloride products and other pharmaceuticals. Their international reach guarantees that essential medications are accessible to healthcare providers and patients across diverse regions, elevating patient care to a global level. This extensive accessibility ensures that patients can access vital medications when and where needed. Investment in research and development (R&D) underscores Taj Pharmaceuticals’ dedication to pharmaceutical innovation and improvement. This commitment to R&D holds the potential to lead to the development of more effective and advanced formulations of Xylometazoline Hydrochloride, which could enhance its therapeutic benefits for patients. The reliability of the pharmaceutical supply chain is of paramount importance, and Taj Pharmaceuticals excels in this regard. Their commitment to supply chain management ensures a consistent and dependable supply of pharmaceuticals, safeguarding healthcare institutions and patients against interruptions in access to vital treatments. Taj Pharmaceuticals’ commitment to affordability is another noteworthy aspect. By offering competitive pricing options, the company makes Xylometazoline Hydrochloride products more accessible to healthcare providers and patients. This dedication aligns with the goal of ensuring that essential medications are within reach of all individuals, without imposing financial barriers.

What is Xylometazoline Hydrochloride and its uses:

Xylometazoline Hydrochloride is a medication primarily used as a nasal decongestant. It belongs to a class of drugs known as alphaadrenergic agonists and is available in various formulations, including nasal sprays and drops. Xylometazoline Hydrochloride is commonly used for the following purposes:

  • Nasal Congestion: Xylometazoline Hydrochloride is widely used to relieve nasal congestion caused by various conditions, including the common cold, allergies (hay fever), sinusitis, and other respiratory infections. It works by constricting the blood vessels in the nasal passages, reducing swelling and congestion, which leads to improved airflow and easier breathing.
  • Sinusitis: Individuals with sinusitis, an inflammation of the sinuses often associated with nasal congestion and pain, may use Xylometazoline Hydrochloride to alleviate these symptoms. By reducing congestion and inflammation in the nasal passages, it can provide relief and improve comfort.
  • Allergic Rhinitis: Xylometazoline Hydrochloride can be beneficial for individuals with allergic rhinitis or hay fever, which is characterized by symptoms like a runny or stuffy nose, sneezing, and itching. By relieving nasal congestion, it helps manage these allergic symptoms.
  • Presurgical Use: In some cases, Xylometazoline Hydrochloride may be used before certain medical procedures or surgeries involving the nose or nasal passages. It can help reduce bleeding during these procedures by constricting blood vessels.
  • Otitis Media: Occasionally, Xylometazoline Hydrochloride may be recommended for individuals with otitis media (middle ear infection) or eustachian tube dysfunction. It can help alleviate earrelated symptoms by reducing nasal congestion, which can contribute to ear discomfort.
  • Recovery from Nasal Surgery: Following nasal surgery, such as septoplasty or rhinoplasty, Xylometazoline Hydrochloride may be prescribed to reduce postoperative nasal congestion and promote healing.

How Does Xylometazoline Hydrochloride work?

Xylometazoline Hydrochloride works as a nasal decongestant by constricting the blood vessels in the nasal passages. This constriction of blood vessels, known as vasoconstriction, leads to several effects that help relieve nasal congestion:

  • Reduced Blood Flow: Xylometazoline Hydrochloride narrows the blood vessels in the nasal lining. This reduction in blood flow decreases the amount of blood in the nasal tissues, which, in turn, reduces the swelling and congestion of the nasal passages. As a result, the nasal passages become less congested, allowing for improved airflow.
  • Decreased Mucus Production: The medication can also reduce the production of mucus in the nasal passages. When the blood vessels constrict, there is less fluid leakage into the nasal tissues, leading to decreased mucus production. This can help individuals with a runny or stuffy nose by reducing the excessive production of mucus associated with nasal congestion.
  • Improved Breathing: By relieving nasal congestion and reducing mucus production, Xylometazoline Hydrochloride facilitates easier breathing. This effect is particularly helpful for individuals experiencing nasal congestion due to various causes, such as allergies, the common cold, sinusitis, or other respiratory conditions.
  • Extended Relief: Xylometazoline Hydrochloride is designed to provide relatively long-lasting relief from nasal congestion. A single application of the medication can offer several hours of relief, allowing individuals to breathe more comfortably.

It’s important to note that Xylometazoline Hydrochloride is intended for short-term use to provide temporary relief from nasal congestion. Prolonged or excessive use of nasal decongestants like Xylometazoline Hydrochloride can lead to a condition known as “rebound congestion” or “rhinitis medicamentosa,” where the nasal passages become even more congested when the medication wears off. Therefore, it should be used strictly as directed by a healthcare provider or following the instructions provided with the specific product. If symptoms persist or worsen, or if there are concerns about its use, it’s essential to seek guidance from a healthcare professional.

Benefits of Xylometazoline Hydrochloride:

  • Nasal Congestion Relief: Xylometazoline Hydrochloride is primarily used to provide relief from nasal congestion caused by various conditions such as the common cold, allergies, sinusitis, and respiratory infections. It works quickly to reduce swelling and congestion in the nasal passages, allowing individuals to breathe more easily.
  • Improved Breathing: By narrowing the blood vessels in the nasal lining and reducing mucus production, Xylometazoline Hydrochloride facilitates improved airflow through the nasal passages, making breathing more comfortable for individuals experiencing congestion.
  • Quick Onset of Action: This medication typically works within minutes of application, offering rapid relief from nasal congestion, which can be especially beneficial when individuals are struggling to breathe due to blocked nasal passages.
  • Long-Lasting Relief: Xylometazoline Hydrochloride provides relatively long-lasting relief from nasal congestion, with a single application offering several hours of symptom relief. This allows individuals to go about their daily activities without the need for frequent reapplication.

Common Side Effects of Xylometazoline Hydrochloride:

  • Rebound Congestion: One of the primary concerns with Xylometazoline Hydrochloride is the risk of rebound congestion. Prolonged or excessive use of this nasal decongestant can lead to a worsening of nasal congestion when the medication wears off. To minimize this risk, it should be used strictly as directed and for short-term relief.
  • Dryness and Irritation: Some individuals may experience dryness and irritation in the nasal passages as a side effect of Xylometazoline Hydrochloride. This can lead to a sensation of burning or stinging in the nose.
  • Sneezing or Runny Nose: Paradoxically, Xylometazoline Hydrochloride can sometimes cause an increase in sneezing or a runny nose, especially if used excessively. This is another reason why it should be used sparingly and for short durations.
  • Nasal Discomfort: Individuals may occasionally experience discomfort in the nasal passages, including sensations of tightness or pressure.
  • Headache: Some users may develop mild headaches as a side effect of using Xylometazoline Hydrochloride.
  • Nausea: Nausea is a less common side effect but may occur in some individuals.
  • Sleep Disturbances: In rare cases, Xylometazoline Hydrochloride may lead to sleep disturbances, particularly if used close to bedtime.

It’s important to use Xylometazoline Hydrochloride strictly as directed by a healthcare provider or following the instructions provided with the specific product. This will help minimize the risk of rebound congestion and other potential side effects. If side effects persist or worsen, or if there are any concerns about its use, it’s essential to seek guidance from a healthcare professional. Individuals with certain medical conditions or those taking specific medications should consult a healthcare provider before using this medication.

Frequently Asked Questions About Xylometazoline Hydrochloride:

Certainly, here are some frequently asked questions (FAQs) about Xylometazoline Hydrochloride:

  1. What is Xylometazoline Hydrochloride used for?

Xylometazoline Hydrochloride is primarily used as a nasal decongestant to relieve nasal congestion caused by conditions such as the common cold, allergies, sinusitis, or respiratory infections.

  1. How does Xylometazoline Hydrochloride work?

Xylometazoline Hydrochloride works by constricting the blood vessels in the nasal passages, reducing swelling and congestion. This leads to improved airflow and easier breathing.

  1. How quickly does Xylometazoline Hydrochloride work?

Xylometazoline Hydrochloride typically works within minutes of application, offering rapid relief from nasal congestion.

  1. Can I use Xylometazoline Hydrochloride for an extended period?

Xylometazoline Hydrochloride is intended for short-term use to provide temporary relief from nasal congestion. Prolonged or excessive use can lead to rebound congestion, where the nasal passages become even more congested when the medication wears off. It should be used strictly as directed.

  1. Are there any side effects of Xylometazoline Hydrochloride?

Common side effects may include rebound congestion, dryness and irritation in the nasal passages, sneezing, headache, nasal discomfort, and, in rare cases, nausea or sleep disturbances. It’s essential to use the medication as directed to minimize these side effects.

  1. Can I use Xylometazoline Hydrochloride if I have high blood pressure?

Individuals with high blood pressure (hypertension) or certain cardiovascular conditions should use Xylometazoline Hydrochloride with caution and consult a healthcare provider before use. It can temporarily increase blood pressure.

  1. Can Xylometazoline Hydrochloride be used in children?

Xylometazoline Hydrochloride can be used in children, but it should be used according to the specific dosing recommendations for the child’s age. It is essential to follow the guidance of a healthcare provider or the instructions provided with the product.

  1. Can pregnant or breastfeeding women use Xylometazoline Hydrochloride?

Pregnant or breastfeeding women should consult a healthcare provider before using Xylometazoline Hydrochloride to assess its safety and appropriateness during pregnancy or while breastfeeding.

  1. Can I use Xylometazoline Hydrochloride with other medications?

It’s important to inform your healthcare provider or pharmacist about all medications, including over-the-counter drugs and supplements, that you are taking. They can help determine if there are any potential interactions or contraindications.

  1. How often can I use Xylometazoline Hydrochloride?

The frequency of use depends on the specific product and its dosing instructions. It’s crucial to adhere to the recommended dosing regimen and not use it more frequently or for longer durations than directed to avoid rebound congestion.

Always consult with a healthcare provider or pharmacist if you have questions or concerns about using Xylometazoline Hydrochloride or if you experience any unusual side effects or symptoms while using the medication.

As Xylometazoline Hydrochloride Exporters; We can cater to export business queries from the following geographies. We are exporting our Xylometazoline Hydrochloride product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Xylometazoline Hydrochloride Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Xylometazoline Hydrochloride, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274