ACTINAC PLUS Film-coated tablet Ref.[115633] Active ingredients: Aceclofenac Paracetamol

Source: Registered Drug Product Database (NG)  Publisher: Ajanta Pharma Limited, Ajanta House, Charkop, Kandivli (West), Mumbai - 400 067, India Manufacturing site address: Ajanta Pharma Limited, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, Maharashtra, India, Telephone: (0091) 2431232123, Fax: (0091) 2431232088, e-mail: info@ajantapharma.com

Product name and form

Actinac Plus (Aceclofenac 100 mg and Paracetamol 500 mg Tablets).

Pharmaceutical Form

Film coated tablet.

Qualitative and quantitative composition

Each film coated tablet contains:

Acceclofenac BP 100 mg

Paracetamol BP 500 mg

Colour: Quinoline Yellow WS, Sunset Yellow FCF & Titanium Dioxide.

Active Ingredient

Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins.

Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain.

List of Excipients

Microcrystlline cellulose
Croscarmellose sodium
Purified talc
Magnesium stearate
Wincoat WT-1079 orange
Quinoline yellow
Titanium dioxide
Isopropyl alcohol
Dichloromethane (Methylene chloride)

Wincoat WT-1079 Orange comprises of Hydroxy Propyl Methyl Cellulose, Diethyl Phthalate, Titanium Dioxide, Talcum, Aluminium Lake of Sunset Yellow

Pack sizes and marketing

10 tablets are packed into one blister pack. Such 2 blisters are packed in a carton along with pack insert.

Marketing authorization holder

Ajanta Pharma Limited, Ajanta House, Charkop, Kandivli (West), Mumbai – 400 067, India

Manufacturing site address:

Ajanta Pharma Limited, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, Maharashtra, India, Telephone: (0091) 2431232123, Fax: (0091) 2431232088, e-mail: info@ajantapharma.com

Marketing authorization dates and numbers

A4-7482

Mar 08, 2012

Drugs

Drug Countries
ACTINAC PLUS Nigeria

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