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 (650mg+50mg) Technical Specification:

Product Name:Paracetamol & Orphenadrine Citrate Tablets (650mg+50mg)
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 (650mg+50mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Paracetamol & Orphenadrine Citrate Tablets (650mg+50mg)
    Composition:
    Each film-coated tablet contains:
    Paracetamol BP …………………….….650mg
    Orphenadrine Citrate BP……………50mg
    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.