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Paracetamol and Orphenadrine Citrate Tablets

Paracetamol and Orphenadrine Citrate Tablets

Composition: Each uncoated tablet contains Paracetamol 450 mg and Orphenadrine Citrate 35 mg; excipients q.s.

Usage: Painful musculoskeletal spasm, where locally approved.

Category: Analgesic Painkiller Drugs

Therapeutic class: Analgesic + Skeletal Muscle Relaxant

SKU: Paracetamol and Orphenadrine Citrate Tablets

Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations

Product Information

Paracetamol and Orphenadrine Citrate Tablets is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

Product Description

Manufacturer named in supplied content: Healthy Life Pharma Pvt. Ltd. Exporter named: Healthy Inc. Certifications and authorizations require verification.

1. Product Introduction

Paracetamol and Orphenadrine Citrate Tablets combine an analgesic with a centrally acting skeletal muscle relaxant with anticholinergic properties. The supplied formulation is intended for pain associated with musculoskeletal muscle spasm, where locally authorized and prescribed by a healthcare professional.

Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied marketing material. Contract manufacturing capacity, certifications and market availability require documentary verification.

2. Product Specifications

ParameterDeclared specification
ProductParacetamol and Orphenadrine Citrate Tablets
Per uncoated tabletParacetamol 450 mg + Orphenadrine Citrate 35 mg; excipients q.s.
Dosage formUncoated tablet
Therapeutic categoryAnalgesic + centrally acting muscle relaxant
CategoryAnalgesic Painkiller Drugs
SKUParacetamol and Orphenadrine Citrate Tablets
Pharmacopoeial standardNot stated for the combination; confirm with approved label
Pack / shelf lifeTo be confirmed from product-specific documentation

Separate products in the supplied catalogue: Paracetamol-only IP 500/650 mg and BP 100/250 mg; Ibuprofen IP 400 mg + Paracetamol IP 325 mg (Parafen te); Paracetamol + Caffeine BP 325/30 mg and 500/30 mg; and two multi-ingredient cold formulations. These are not strengths of the Orphenadrine combination. The 650 mg + 50 mg Orphenadrine combination appears only in the narrative, not in the supplied product composition, and requires verification.

3. Manufacturing Technology

Combination tablets require validated blending and content-uniformity controls to distribute the lower-dose orphenadrine consistently alongside paracetamol. Appropriate granulation, compression, packaging and stability approaches depend on the approved manufacturing process.

Claims regarding particular mixing equipment, film coating or humidity-controlled suites should be supported by batch manufacturing records and specifications. The supplied tablet is described as uncoated, not film-coated or bilayer.

4. Quality Assurance

Quality evaluation should follow the applicable approved specification, including identification and assay of both active ingredients, content uniformity, dissolution or disintegration as applicable, impurities, microbiological quality where relevant, and stability. Specific numeric acceptance limits and a 36-month shelf life cannot be confirmed from the supplied composition alone.

5. Pharmacology and Clinical Use

Paracetamol: Analgesic and antipyretic that reduces pain and fever. Orphenadrine citrate: Centrally acting skeletal muscle relaxant with anticholinergic activity. Depending on the local approved indication, this combination may be prescribed as an adjunct for painful musculoskeletal conditions associated with muscle spasm.

Paracetamol is not an NSAID. This formulation should not be presented as a general anti-inflammatory medicine. Evidence and approvals vary by market.

6. Export and Regulatory Support

Product registration and supply may require country-specific dossiers, approved product labels, manufacturing licences, certificates of analysis, stability evidence and other documentation. CTD/ACTD dossiers, WHO-GMP certification, COPP, FSC, Star Export House status, and export destinations must be confirmed before making public claims or quotations.

7. Frequently Asked Questions

What is the confirmed strength? Paracetamol 450 mg with Orphenadrine Citrate 35 mg per uncoated tablet.

Can it cause drowsiness? Yes. Orphenadrine may cause dizziness, blurred vision or drowsiness; avoid driving if affected.

Is it an NSAID? No. Paracetamol is an analgesic/antipyretic, and orphenadrine is a muscle relaxant.

Is it equivalent to a particular branded medicine? Equivalence cannot be established from ingredient names alone; strength, dosage form, bioequivalence and regulatory status must be checked.

8. Dosage and Administration

Use only as directed by the prescribing clinician and the locally approved product label. The appropriate dose and duration depend on the indication, age, comorbidities and concomitant medicines. Do not combine with other paracetamol-containing products without checking the total daily dose. Do not exceed the locally approved maximum daily paracetamol exposure.

9. Side Effects and Precautions

Possible adverse effects include dry mouth, constipation, blurred vision, dizziness, drowsiness, palpitations and difficulty urinating due to anticholinergic effects. Caution or avoidance may be required in people with narrow-angle glaucoma, urinary retention or prostatic obstruction, myasthenia gravis, and certain cardiac conditions. Other sedating or anticholinergic medicines can increase adverse effects.

Paracetamol overdose can cause severe liver injury. Seek urgent medical care after a suspected overdose, even if there are initially no symptoms. Stop and seek medical attention for severe allergy or other serious reactions.

10. Storage Instructions

Store according to the approved product label, in the original packaging, protected from excessive moisture and heat, and out of reach of children. Do not assign a specific storage temperature or shelf life without product-specific stability data.