Aceclofenac and Paracetamol Tablets 100mg+325mg Technical Specification:

Product Name:Aceclofenac and Paracetamol Tablets 100mg+325mg
Brand Name:ACETAJ P
Strength:(100mg+325mg), (100mg+500mg)
Dosage Form:Tablets (Film coated)
Route of Administration:Via oral route
Packing:30s, 90s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics).
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Analgesic and Anti-inflammatory, Antirheumatic
Indication: Aceclofenac and Paracetamol tablets is used for fever, Joint pain, Cold, Toothache, Headache, Ear pain and other conditions.
Storage:Do not store above 25°C. Store in the original package in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Aceclofenac and Paracetamol Tablets 100mg+325mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Aceclofenac and Paracetamol Tablets (100mg+325mg)
    Each film-coated tablet contains:
    Aceclofenac BP………..……….100mg
    Paracetamol BP….…………….325mg
    Excipients…………………………q.s
    Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Aceclofenac and Paracetamol tablets is used for fever, Joint pain, Cold, Toothache, Headache, Ear pain and other conditions.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:  Do not store above 25°C. Store in the original package in order to protect from moisture.

Dosage:   As directed by the Physician.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Aceclofenac and Paracetamol Tablets (100mg+325mg)
2. Aceclofenac and Paracetamol Tablets (100mg+500mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Aceclofenac and Paracetamol Tablets (100mg+325mg)
Each film-coated tablet contains:
Aceclofenac BP………..……….100mg
Paracetamol BP….…………….325mg
Excipients…………………………q.s
Colour: Titanium Dioxide USP


2. Aceclofenac and Paracetamol Tablets (100mg+500mg)
Each film-coated tablet contains:
Aceclofenac IP………..……….100mg
Paracetamol BP….…………….500mg
Excipients…………………………q.s
Colour: Red Oxide of Iron

THERAPEUTIC INDICATIONS:

Aceclofenac and Paracetamol tablets is used for fever, Joint pain, Cold, Toothache, Headache, Ear pain and other conditions.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Do not store above 25°C. Store in the original package in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.