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.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Paracetamol & Orphenadrine Citrate Tablets (450mg+35mg)
B. Paracetamol & Orphenadrine Citrate Tablets (650mg+50mg)
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
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.
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.
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.
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.