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ASPIRIN Tablets BP 300mg (2013)

Active ingredients: Acetylsalicylic acid

Product Name and Form

ASPIRIN TABLETS BP 300mg.

Pharmaceutical form

White uncoated tablets.

Qualitative and Quantitative Composition

Each tablet contains 300mg Aspirin PhEur.

Chemical substance
Description
Acetylsalicylic acid

Acetylsalicylic acid combines significant advantages such as strong anti-pyretic, analgesic and anti-inflammatory action, that is the measure of comparison with all the newer NSAIDs.

List of excipients

Also contains maize starch, E553.

Pack sizes and Marketing

OTC Packs: The product containers are polyethylene snap-safe vials (CRC) or, as an alternative, amber glass bottles with clic-loc caps both with integral seal, cotton wool or polyfoam wad headspace filler.

Dispensing Packs: The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

c) Child Resistant Blister Pack: (i) 250µm white rigid PVC. (ii) 9µm soft aluminium / 35g/m² glassine paper.

Pack sizes:

GSL: 7’s, 8’s, 10’s, 14’s, 16’s

P: 20’s, 21’s, 25’s, 28’s, 30’s, 32’s,

POM: 40’s, 48’s, 50’s, 56’s, 60’s, 84’s, 90’s, 100’s, 112’s, 500’s, 1000’s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Marketing authorization holder
Authorization dates

Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:

Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon
EX32 8NS

7.7.80

Marketing authorization number:

PL 0142/5083 R