Paracetamol Tablets IP 650mg Technical Specification:

Product Name:Paracetamol Tablets IP 650mg
Brand Name:Rastovon
Strength:500mg, 650mg, 1000mg
Dosage Form:Tablets (uncoated)
Route of Administration:Via oral route
Packing:30s, 40s, 60s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Analgesic and Anti-inflammatory.
Indication: Paracetamol is a common painkiller used to treat aches and pain.
Storage:Store below 25°C in a dry place. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Paracetamol Tablets IP 650mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Paracetamol Tablets IP 650mg
    Each uncoated tablet contains:
    Paracetamol I.P……………………650mg
    Excipients………………………………… q.s.

THERAPEUTIC INDICATIONS:

Paracetamol has analgesic and antipyretic actions similar to those of aspirin and hence is a suitable alternative for patients sensitive to aspirin. For the relief of mild to moderate pain and febrile conditions, e.g., headache, toothache, colds, influenza, rheumatic pain and dysmenorrhoea. Paracetamol tablets are indicated in adults and children aged 10 to 18.

CAUTION & Schedule:

CAUTION:  Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Contraindications: Hypersensitivity to any of the ingredients.

This medicine should be used with caution in patients is with Liver diseases.

Paracetamol overdose may be Injurious to liver.

Schedule: Schedule H PRESCRIPTION DRUG: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Store below 25°C in a dry place. Protect from light.

Dosage:
Adults & 12 years and above:
1 tablet 4-6 hourly up to maximum 4000mg per day.
Children 6-11 years: 10-14mg/kg 4-6 hourly up to maximum 60mg/kg per day.
Minimum dosing interval: 4 hours
Do not exceed dose or use without medical advice beyond 3 days.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Paracetamol Tablets IP 500mg
B. Paracetamol Tablets IP 650mg
C. Paracetamol Tablets IP 1000mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Paracetamol Tablets IP 500mg
Each uncoated tablet contains:
Paracetamol I.P…………………...500mg
Excipients………………………………... q.s.

B. Paracetamol Tablets IP 650mg
Each uncoated tablet contains:
Paracetamol I.P………………….650mg
Excipients…………………………………q.s.


C. Paracetamol Tablets IP 1000mg
Each uncoated tablet contains:
Paracetamol I.P………………...1000mg
Excipients………………………………. q.s.

THERAPEUTIC INDICATIONS:

Paracetamol has analgesic and antipyretic actions similar to those of aspirin and hence is a suitable alternative for patients sensitive to aspirin. For the relief of mild to moderate pain and febrile conditions, e.g., headache, toothache, colds, influenza, rheumatic pain and dysmenorrhoea. Paracetamol tablets are indicated in adults and children aged 10 to 18.

CAUTION & SCHEDULE:

CAUTION: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Contraindications: Hypersensitivity to any of the ingredients.
This medicine should be used with caution in patients is with Liver diseases.
Paracetamol overdose may be Injurious to liver.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG:To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place.
Protect from light.
Dosage:
Adults & 12 years and above:
1 tablet 4-6 hourly up to maximum 4000mg per day.
Children 6-11 years: 10-14mg/kg 4-6 hourly up to maximum 60mg/kg per day.
Minimum dosing interval: 4 hours
Do not exceed dose or use without medical advice beyond 3 days.
Attach dispensing label as per end country.