GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Paracetamol & Orphenadrine Citrate Tablets (450mg+35mg)
B. Paracetamol & Orphenadrine Citrate Tablets (650mg+50mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Paracetamol & Orphenadrine Citrate Tablets (450mg+35mg)
Composition:
Each film-coated tablet contains:
Paracetamol BP …………………….….450mg
Orphenadrine Citrate BP……………35mg
Excipients…………………………………. q.s.
Colours: Titanium Dioxide USP


B. Paracetamol & Orphenadrine Citrate Tablets (650mg+50mg)
Composition:
Each film-coated tablet contains:
Paracetamol BP …………………...650mg
Orphenadrine Citrate BP………….50mg
Excipients…………………………………. q.s.
Colours: Red Oxide of Iron

THERAPEUTIC INDICATIONS:

Paracetamol & Orphenadrine Citrate Tablets used for the relief of painful skeletal muscle spasm associated with chronic low back pain, sprains, strains, prolapsed intervertebral disc, muscle injury, non-articular rheumatism, and tension headache, dysmenorrheal and other acute or chronic painful muscular conditions.

DIRECTIONS:

Paracetamol possess analgesic and antipyretic action similar to those of the salicylates.
Analgesia is mediated peripherally and also centrally.
Paracetamol is a synthetic derivative of p-aminophenol with analgesic and antipyretic activity but no anti-inflammatory action.
Its plasma half-life is about 2 hours.

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.
Swallow whole do not chew or crush.
WARNING: Do not skip/discontinue the dose for effective treatment.
The dosage used 2 tablets three times daily. The effect of treatment of pain was assessed daily using a visual analogue scale.
Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.
2 tablets three times daily.
Note: Paracetamol can be taken with or without food.
The usual dose for adults is one or two 500mg tablets up to 4 times in 24 hours.
Always leave at least 4 hours between doses.

Paracetamol & Orphenadrine Citrate Tablets (450mg+35mg) Technical Specification:

Product Name:Paracetamol & Orphenadrine Citrate Tablets (450mg+35mg)
Brand Name:ORPETAJ
Strength:(450mg+35mg), (650mg+50mg)
Dosage Form:Film-coated tablets
Packing:10s, 20s, 30s Blisters
Route of Administration:For Oral Use Only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Muscle Relaxant, Analgesic, Antipyretic
Indication: Paracetamol & Orphenadrine Citrate Tablets used for the relief of painful skeletal muscle spasm associated with chronic low back pain, sprains, strains, prolapsed intervertebral disc, muscle injury, non-articular rheumatism, and tension headache, dysmenorrheal and other acute or chronic painful muscular conditions.
Storage:Store protected from moisture at a temperature not exceeding 25°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Paracetamol & Orphenadrine Citrate Tablets (450mg+35mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Paracetamol & Orphenadrine Citrate Tablets (450mg+35mg)
    Composition:
    Each film-coated tablet contains:
    Paracetamol BP …………………….….450mg
    Orphenadrine Citrate BP……………35mg
    Excipients…………………………………. q.s.
    Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Paracetamol & Orphenadrine Citrate Tablets used for the relief of painful skeletal muscle spasm associated with chronic low back pain, sprains, strains, prolapsed intervertebral disc, muscle injury, non-articular rheumatism, and tension headache, dysmenorrheal and other acute or chronic painful muscular conditions.

DIRECTIONS:

Paracetamol possess analgesic and antipyretic action similar to those of the salicylates.

Analgesia is mediated peripherally and also centrally.

Paracetamol is a synthetic derivative of p-aminophenol with analgesic and antipyretic activity but no anti-inflammatory action.

Its plasma half-life is about 2 hours.

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.

Swallow whole do not chew or crush.

WARNING: Do not skip/discontinue the dose for effective treatment.

The dosage used 2 tablets three times daily. The effect of treatment of pain was assessed daily using a visual analogue scale.

Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 25°C.

Dosage: As directed by the Physician.
2 tablets three times daily.

Note: Paracetamol can be taken with or without food.
The usual dose for adults is one or two 500mg tablets up to 4 times in 24 hours.
Always leave at least 4 hours between doses.

Why Taj Pharmaceuticals?

When it comes to Paracetamol & Orphenadrine Citrate Tablets, Taj Pharma stands out as the preferred choice. With a legacy of pharmaceutical excellence, Taj Pharma ensures that you receive only the best in medication. Our commitment to quality extends to rigorous testing and adherence to industry standards, guaranteeing the safety and efficacy of every tablet. At Taj Pharma, we understand the importance of providing reliable and accessible healthcare solutions. Our Paracetamol & Orphenadrine Citrate Tablets are crafted with precision to address your specific needs, whether it’s pain relief, muscle relaxation, or both. With Taj Pharma, you can trust that your well-being is in capable hands. Experience the difference of Taj Pharma’s commitment to innovation and customer satisfaction. Choose us for Paracetamol & Orphenadrine Citrate Tablets that you can rely on, and take a step towards a healthier, pain-free life. Your health is our priority, and Taj Pharma is here to support you every step of the way. Looking for top-quality Paracetamol & Orphenadrine Citrate Tablets. Trust Taj Pharma for excellence in pharmaceuticals. Our commitment to quality ensures safe and effective medication.

What is Paracetamol & Orphenadrine Citrate Tablets and its use?

Paracetamol & Orphenadrine Citrate Tablets are a combination medication used to treat various conditions, primarily those involving pain and muscle spasms. Here’s a breakdown of each component and their uses:

Paracetamol (also known as Acetaminophen):

  • Paracetamol is a common overthecounter pain reliever and fever reducer.
  • It is used to alleviate mild to moderate pain associated with conditions such as headaches, muscle aches, toothaches, menstrual cramps, and osteoarthritis.
  • Paracetamol is often used as a firstline treatment for pain due to its safety profile when taken at recommended doses.

Orphenadrine Citrate:

  • Orphenadrine is a muscle relaxant that works by blocking nerve impulses (pain sensations) that are sent to the brain.
  • It is used to relieve muscle spasms and associated pain caused by conditions like muscle strains, sprains, or muscle injuries.
  • Orphenadrine Citrate is often prescribed as an adjunct therapy in situations where muscle relaxation is necessary along with pain relief.

The combination of Paracetamol and Orphenadrine Citrate in a single tablet provides the benefit of both pain relief and muscle relaxation, making it suitable for conditions that involve both muscle tension and pain.

The use of Paracetamol & Orphenadrine Citrate Tablets should be under the guidance of a healthcare professional. Always follow the recommended dosage and guidelines provided by your doctor or pharmacist to ensure safe and effective treatment. Additionally, be aware of potential side effects and interactions with other medications, and inform your healthcare provider about any existing medical conditions or medications you may be taking.

How does Paracetamol & Orphenadrine Citrate Tablets Work?

Paracetamol & Orphenadrine Citrate Tablets work through the combined actions of their two active ingredients, paracetamol (acetaminophen) and orphenadrine citrate, to provide relief from pain and muscle spasms:

Paracetamol (Acetaminophen):

  • Paracetamol is primarily known for its analgesic (pain-relieving) and antipyretic (fever-reducing) properties.
  • It works by inhibiting the activity of an enzyme called cyclooxygenase (COX). COX is involved in the production of prostaglandins, which are chemicals in the body that promote pain and fever.
  • By reducing the production of prostaglandins in the brain and spinal cord, paracetamol helps to lower pain perception and reduce fever.

Orphenadrine Citrate:

  • Orphenadrine is a muscle relaxant that acts on the central nervous system.
  • It works by blocking nerve impulses or signals that are responsible for muscle contractions and spasms.
  • By inhibiting these nerve signals, orphenadrine helps to relax the skeletal muscles, reducing muscle spasms and associated pain.

When combined in a single tablet, Paracetamol & Orphenadrine Citrate Tablets offer a dual mechanism of action. Paracetamol addresses pain and fever by reducing the perception of pain and lowering fever, while orphenadrine citrate targets muscle spasms by relaxing the affected muscles. This combination can be especially effective for conditions where both pain and muscle tension are present, such as musculoskeletal injuries or certain types of headaches.

It’s important to use these tablets as directed by a healthcare professional, as improper use or exceeding recommended dosages can lead to adverse effects. Always follow the dosage instructions provided on the medication packaging or as prescribed by your doctor. If you have any questions or concerns about how Paracetamol & Orphenadrine Citrate Tablets work or their appropriate use, consult your healthcare provider or pharmacist for guidance.

Benefits and Side effects of Paracetamol & Orphenadrine Citrate Tablets:

Paracetamol & Orphenadrine Citrate Tablets offer benefits in providing relief from pain and muscle spasms, but they also come with potential side effects. Here are the benefits and possible side effects associated with this medication:

Benefits:

  • Pain Relief: The combination of paracetamol (acetaminophen) and orphenadrine citrate provides effective pain relief. Paracetamol is known for its analgesic properties, helping to alleviate mild to moderate pain, while orphenadrine citrate acts as a muscle relaxant, reducing muscle spasms and associated pain.
  • Muscle Relaxation: Orphenadrine citrate’s muscle relaxant properties make this medication particularly useful for conditions involving muscle tension, such as muscle strains, sprains, or injuries. It can help relax skeletal muscles and reduce muscle spasms.
  • Fever Reduction: Paracetamol also has antipyretic properties, which means it can lower fever by reducing the body’s temperature-regulating set point in the brain.
  • Combination Therapy: The combination of these two active ingredients in a single tablet provides a comprehensive approach to addressing conditions that involve both pain and muscle spasms, potentially offering more effective relief than either component alone.

Side Effects:

It’s important to note that while Paracetamol & Orphenadrine Citrate Tablets can be beneficial, they can also cause side effects in some individuals. Common side effects may include:

  • Drowsiness: Orphenadrine citrate can cause drowsiness or dizziness in some people. It’s essential to avoid activities that require mental alertness, such as driving or operating heavy machinery, if you experience these side effects.
  • Dry Mouth: Dry mouth is a common side effect of orphenadrine citrate. Staying hydrated and using sugar-free lozenges or gum can help alleviate this symptom.
  • Nausea or Upset Stomach: Some individuals may experience stomach discomfort or nausea when taking this medication. Taking it with food or milk can help reduce these side effects.
  • Blurred Vision: Blurred vision can occur as a side effect, mainly due to orphenadrine citrate. If you experience this, avoid activities that require clear vision until it subsides.
  • Allergic Reactions: While rare, allergic reactions such as skin rash, itching, swelling, severe dizziness, or difficulty breathing can occur. Seek immediate medical attention if you experience any signs of an allergic reaction.
  • Liver Damage: Paracetamol, if taken in excessive doses, can potentially cause liver damage. It’s crucial to follow the recommended dosage and avoid consuming other products containing paracetamol simultaneously.
  • Other Side Effects: Less common side effects may include constipation, urinary retention, increased heart rate, and confusion.

It’s essential to use Paracetamol & Orphenadrine Citrate Tablets under the guidance of a healthcare professional, following their recommended dosage and guidelines. If you experience severe or persistent side effects, consult your healthcare provider promptly. Additionally, inform your healthcare provider of any existing medical conditions or medications you may be taking to minimize the risk of interactions or adverse effects.

Frequently asked questions (FAQs) about Paracetamol & Orphenadrine Citrate Tablets along with their answers:

  1. What are Paracetamol & Orphenadrine Citrate Tablets used for?

Paracetamol & Orphenadrine Citrate Tablets are primarily used to provide relief from pain, muscle spasms, and fever. They are commonly prescribed for conditions involving muscle tension, such as muscle strains, sprains, and injuries.

  1. How do Paracetamol & Orphenadrine Citrate Tablets work?

Paracetamol (acetaminophen) reduces pain and fever by inhibiting the production of prostaglandins, while orphenadrine citrate acts as a muscle relaxant by blocking nerve impulses responsible for muscle contractions.

  1. What is the recommended dosage of Paracetamol & Orphenadrine Citrate Tablets?

The recommended dosage can vary based on your age, medical condition, and the specific product prescribed. Always follow your healthcare provider’s instructions or the dosing information on the medication label.

  1. Can I take Paracetamol & Orphenadrine Citrate Tablets with other medications?

It’s important to inform your healthcare provider about all medications you are taking to check for potential drug interactions. Some medications or medical conditions may interact with Paracetamol & Orphenadrine Citrate Tablets.

  1. Are there any potential side effects of these tablets?

Yes, Paracetamol & Orphenadrine Citrate Tablets can have side effects, including drowsiness, dry mouth, upset stomach, nausea, and blurred vision. Rare but severe side effects may include allergic reactions and liver damage. Consult your healthcare provider if you experience any adverse effects.

  1. Can I drive or operate heavy machinery while taking these tablets?

Orphenadrine citrate can cause drowsiness and blurred vision in some individuals. If you experience these side effects, it’s advisable to avoid activities that require mental alertness, such as driving or operating heavy machinery.

  1. Is it safe to drink alcohol while taking Paracetamol & Orphenadrine Citrate Tablets?

Alcohol can enhance the sedative effects of orphenadrine citrate and may increase the risk of side effects. It’s generally best to avoid alcohol while taking this medication.

  1. What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. However, if it’s close to your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

  1. Can I use these tablets during pregnancy or while breastfeeding?

It’s essential to consult your healthcare provider before using Paracetamol & Orphenadrine Citrate Tablets during pregnancy or while breastfeeding. They can provide guidance based on your specific situation.

  1. How should I store these tablets?

Store the tablets at room temperature, away from moisture and heat. Keep them out of reach of children and pets.

As Paracetamol & Orphenadrine Citrate Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Paracetamol & Orphenadrine Citrate Tablets 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

Paracetamol & Orphenadrine Citrate 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 Paracetamol & Orphenadrine Citrate 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