GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)
Each Uncoated Sustained-Release tablet contain:
Levocetirizine Hydrochloride USP………….5mg
(As Immediate Release)
Pseudoephedrine Hydrochloride USP………120mg
(As Sustained-Release)
Excipients……………………………………q.s.
Color: Ferric Oxide Red USP-NF

THERAPEUTIC INDICATIONS:

LEVOCETIRIZINE+PSEUDOEPHEDRINE is a respiratory medication, primarily used to treat symptoms of the common cold, flu, and allergies such as sneezing, runny nose, nasal and sinus congestion, stuffy nose, or watery eyes.
LEVOCETIRIZINE+PSEUDOEPHEDRINE consists of two medicines: Levocetirizine (antihistamine) and Pseudoephedrine (decongestant). Levocetirizine belongs to the class of antihistamines or anti-allergic that works by blocking the action of histamine, a substance responsible for causing allergic reactions.

CAUTION & WARNING:

CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Read enclosed leaflet before use.
WARNING:
To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
DO NOT STOP OR SKIP MEDICINE WITHOUT PHYSICIAN’S ADVICE.
DO NOT CONSUME MORE THAM THE PRESCRIBED QUANTITY.
Alert: Stop taking REXAFED OD SR Tablet
and consult your doctor immediately if:
1-nervousness, sleepiness, or dizziness
2. Gestures/thoughts of harming yourself

STORAGE & DOSAGE:

Storage:
Store at controlled room temperature of 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59 to 86°F) [see USP Controlled room Temperature].
Protect from light & moisture.
Keep in a cool & dry place.
Dosage:
As directed by the Physician

Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg) Technical Specification:

Product Name:Levocetirizine Hydrochloride 5mg & Pseudoephedrine Hydrochloride 120mg SR Tablets
Brand Name:REXICOLD
Strength:(5mg+120mg)
Dosage Form:Sustained-Release Tablets (Uncoated)
Route of Administration:Via Oral Route
Packing:10s, 20s, 30s, 50s, 150s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antihistamines, Anti-Allergic, Decongestant
Indication: LEVOCETIRIZINE+PSEUDOEPHEDRINE is a respiratory medication, primarily used to treat symptoms of the common cold, flu, and allergies such as sneezing, runny nose, nasal and sinus congestion, stuffy nose, or watery eyes.
LEVOCETIRIZINE+PSEUDOEPHEDRINE consists of two medicines: Levocetirizine (antihistamine) and Pseudoephedrine (decongestant). Levocetirizine belongs to the class of antihistamines or anti-allergic that works by blocking the action of histamine, a substance responsible for causing allergic reactions.
Storage:Store at a controlled room temperature of 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)
    Each Uncoated Sustained-Release tablet contains:
    Levocetirizine Hydrochloride USP………….5mg
    (As Immediate Release)
    Pseudoephedrine Hydrochloride USP………120mg
    (As Sustained-Release)
    Excipients……………………………………q.s.
    Color: Ferric Oxide Red USP-NF 

THERAPEUTIC INDICATIONS:

LEVOCETIRIZINE+PSEUDOEPHEDRINE is a respiratory medication, primarily used to treat symptoms of the common cold, flu, and allergies such as sneezing, runny nose, nasal and sinus congestion, stuffy nose, or watery eyes.
LEVOCETIRIZINE+PSEUDOEPHEDRINE consists of two medicines: Levocetirizine (antihistamine) and Pseudoephedrine (decongestant). Levocetirizine belongs to the class of antihistamines or anti-allergic that works by blocking the action of histamine, a substance responsible for causing allergic reactions.

CAUTION & WARNING:

CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take the whole tablet with water.
Read the enclosed leaflet before use.
Keep the medicine out of reach of children. 

WARNING:
To be sold by retail on the prescription of a Registered Medical Practitioner only. 

DO NOT STOP OR SKIP MEDICINE WITHOUT A PHYSICIAN’S ADVICE.

DO NOT CONSUME MORE THAN THE PRESCRIBED QUANTITY.

Alert:

Stop taking REXAFED OD SR Tablet
and consult your doctor immediately if:
1-nervousness, sleepiness, or dizziness
2-Gestures/thoughts of harming yourself.

STORAGE & DOSAGE:

Storage:
Store at a controlled room temperature of 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Protect from light & moisture.
Keep in a cool & dry place.

Dosage:
As directed by the Physician.

Why Taj Pharmaceuticals?

Elevate your allergy and congestion management with Taj Pharmaceuticals’ Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets. We have been a leading name in the pharmaceutical industry for decades, and our commitment to your health and well-being is unwavering.

  • Quality Assurance: At Taj Pharmaceuticals, quality is not just a promise but a practice. Our Levocetirizine and Pseudoephedrine tablets adhere to the highest pharmaceutical standards, ensuring consistent and reliable relief from allergies and congestion.
  • Proven Efficacy: Our combination medication is designed to provide you with superior relief. Levocetirizine is an effective antihistamine that alleviates allergy symptoms, while Pseudoephedrine is a decongestant that helps relieve nasal congestion, making it a comprehensive solution for your needs.
  • Expertise You Can Trust: With years of pharmaceutical expertise, Taj Pharmaceuticals understands the importance of delivering medications that enhance your quality of life. Count on us for trusted and proven solutions.
  • Your Wellness Matters: At Taj Pharmaceuticals, your well-being is at the forefront of everything we do. We strive to provide you with the tools to manage allergies and congestion effectively, so you can enjoy a healthier and more comfortable life.

Choose Taj Pharmaceuticals for Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets that elevate your quality of life, ensuring you can breathe easy and allergy-free. Trust in our legacy of excellence and experience a brighter, symptom-free future.

What is Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets and its uses:

Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets are a combination medication that contains two active ingredients: levocetirizine hydrochloride and pseudoephedrine hydrochloride. Each of these ingredients serves a specific purpose, and the combination is commonly used to treat various allergy and congestionrelated conditions. Here’s an overview:

  • Levocetirizine Hydrochloride:

Levocetirizine is an antihistamine medication. It works by blocking the action of histamine, a chemical that the body releases during allergic reactions. By inhibiting histamine, levocetirizine helps relieve allergy symptoms, including:

  • Sneezing
  • Runny or itchy nose
  • Watery or itchy eyes
  • Itchy or sore throat
  • Skin itching and hives (urticaria)
  • Pseudoephedrine Hydrochloride:

Pseudoephedrine is a decongestant. It works by narrowing the blood vessels in the nasal passages and sinuses. This constriction reduces swelling and congestion, making it easier to breathe. Pseudoephedrine is used to relieve nasal and sinus congestion associated with conditions like:

  • Allergies
  • Hay fever (allergic rhinitis)
  • Common cold
  • Sinusitis

Uses:

Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets are commonly used for the relief of symptoms associated with allergic rhinitis and other upper respiratory allergies, such as sneezing, runny or stuffy nose, itchy or watery eyes, and nasal congestion. This medication is particularly useful when both allergy symptoms and nasal congestion are present simultaneously. It’s important to note that this medication should be taken as directed by a healthcare provider or according to the instructions on the packaging. Dosage may vary depending on age, medical condition, and other factors. Additionally, individuals with certain medical conditions or those taking specific medications should consult their healthcare provider before using this combination product, as it may have contraindications or potential interactions. Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets are available by prescription or overthecounter (OTC), depending on the formulation and local regulations. Always follow your healthcare provider’s guidance or the product label when using this medication.

Benefits and Side Effects of Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets:

Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets are a combination medication used to alleviate allergy symptoms and nasal congestion. Like any medication, they have benefits and potential side effects. Here’s an overview:

Benefits Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets:

  • Allergy Symptom Relief: Levocetirizine is an antihistamine that helps relieve common allergy symptoms such as sneezing, runny or itchy nose, itchy or watery eyes, and itching of the throat or nose. It works by blocking the action of histamine, a chemical in the body that triggers allergic responses.
  • Nasal Congestion Relief: Pseudoephedrine is a decongestant that works by narrowing the blood vessels in the nasal passages, reducing swelling and congestion. This can provide relief from a stuffy or blocked nose caused by allergies or colds.
  • Comprehensive Relief: The combination of Levocetirizine and Pseudoephedrine provides comprehensive relief from allergy symptoms. Levocetirizine addresses the histamine-related symptoms, while Pseudoephedrine tackles nasal congestion, making it effective for conditions like allergic rhinitis.
  • Extended-Release Formulation: Some formulations of these tablets are designed as extended-release, meaning they provide relief over an extended period, typically 12 hours. This allows for less frequent dosing.

Potential Side Effects Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets:

  • Common Side Effects: Levocetirizine and Pseudoephedrine tablets can cause common side effects, including dry mouth, dizziness, headache, and sleep disturbances (such as difficulty falling asleep or staying asleep).
  • Nervousness or Restlessness: Pseudoephedrine, being a stimulant, can sometimes lead to feelings of nervousness or restlessness, especially in sensitive individuals.
  • Increased Blood Pressure: Pseudoephedrine can raise blood pressure in some people. It’s important for individuals with hypertension or heart conditions to use this medication with caution and under medical supervision.
  • Urinary Retention: Pseudoephedrine can cause difficulty urinating or urinary retention in some individuals.9
  • Gastrointestinal Symptoms: Some people may experience stomach upset, nausea, or vomiting as a side effect.
  • Allergic Reactions: Allergic reactions to Levocetirizine or Pseudoephedrine are rare but can occur. Signs of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing.
  • Overuse or Misuse: Misusing or overusing medications containing Pseudoephedrine can lead to serious side effects, including heart problems and dependence.
  • Interactions: Levocetirizine and Pseudoephedrine may interact with other medications you’re taking, potentially affecting their effectiveness or safety. Be sure to inform your healthcare provider about all the medications you are using.

How do Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets work:

Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets are a combination medication used to relieve allergy symptoms and nasal congestion. To understand how these tablets work, let’s break down their mechanisms of action:

  • Levocetirizine Hydrochloride:
    Levocetirizine is an antihistamine. Histamine is a natural substance in the body that is released during an allergic reaction. It binds to histamine receptors, causing allergy symptoms such as itching, sneezing, runny nose, and watery eyes.
    Levocetirizine blocks histamine receptors, preventing histamine from binding to them. By doing so, it reduces or alleviates allergy symptoms.
    Levocetirizine also has anti-inflammatory properties, which help further reduce allergic responses and inflammation.
  • Pseudoephedrine Hydrochloride:
    Pseudoephedrine is a decongestant. Nasal congestion occurs when blood vessels in the nasal passages become swollen and narrowed due to inflammation, typically in response to an allergic reaction or infection.
    Pseudoephedrine works by constricting (narrowing) the blood vessels in the nasal passages. This reduces blood flow to the area, which, in turn, reduces swelling and congestion.
    As a result, Pseudoephedrine relieves nasal congestion, making it easier to breathe through the nose.
  • Combination Action:
    Levocetirizine and Pseudoephedrine work together to provide comprehensive relief from allergy symptoms and congestion.
    Levocetirizine addresses symptoms like itching, sneezing, and runny nose by blocking histamine receptors and reducing inflammation.
    Pseudoephedrine complements this action by narrowing the blood vessels in the nasal passages, relieving congestion and improving airflow through the nose. Together, these medications provide relief from the discomfort and inconvenience of allergies and congestion.

It’s important to note that Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets should be used as directed by a healthcare provider. The combination of these medications may cause side effects in some individuals, and they may not be suitable for everyone. Always consult with a healthcare professional for proper dosing and to ensure this medication is appropriate for your specific condition.

Frequently Asked Questions About Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets:

Certainly, here are some frequently asked questions (FAQs) about Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets, along with their answers:

What are Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets used for?

These tablets are commonly used to relieve allergy symptoms and nasal congestion. Levocetirizine is an antihistamine that helps with allergy symptoms, while Pseudoephedrine is a decongestant that reduces nasal congestion.

How do these tablets work?

Levocetirizine blocks the action of histamine, a chemical that triggers allergy symptoms. Pseudoephedrine shrinks blood vessels in the nasal passages, reducing congestion and making it easier to breathe.

What types of allergies can these tablets help with?

Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets can be effective in managing a range of allergies, including hay fever (seasonal allergic rhinitis) and year-round allergies (perennial allergic rhinitis).

Can these tablets be used for cold symptoms?

Yes, these tablets can provide relief from nasal congestion associated with the common cold and upper respiratory allergies.

Are these tablets available over-the-counter (OTC) or by prescription?

Depending on your location and local regulations, Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets may be available either over-the-counter or by prescription. It’s important to follow the guidance of a healthcare provider or pharmacist when using this medication.

What is the recommended dosage for adults and children?

Dosage instructions can vary based on the specific product and the patient’s age. Always follow the dosing instructions provided on the medication packaging or as directed by a healthcare professional.

Are there any potential side effects of these tablets?

Common side effects can include drowsiness, dry mouth, headache, and increased heart rate. Less common but more severe side effects can occur, such as allergic reactions. Consult your healthcare provider if you experience any concerning side effects.

Can these tablets be taken with other medications?

It’s important to inform your healthcare provider or pharmacist of all medications you are taking, including prescription and over-the-counter drugs, to check for potential interactions. Certain medications, like monoamine oxidase inhibitors (MAOIs), can interact with these tablets and should be avoided.

Can these tablets be taken by pregnant or breastfeeding individuals?

Pregnant or breastfeeding individuals should consult with their healthcare provider before using Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets to determine whether the benefits outweigh any potential risks.

How quickly can I expect relief after taking these tablets?

Relief from allergy symptoms and congestion typically occurs within 30 minutes to an hour after taking the medication. However, individual responses may vary.

As Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Etoricoxib Tablets 90mg product in 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

Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets 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 Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets, 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