ASCORBIC ACID Tablet Ref.[7391] Active ingredients: Vitamin C

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Ennogen Pharma Limited, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS

Product name and form

Ascorbic Acid 100mg Tablets.

Pharmaceutical Form

Tablet.

White to off-white convex tablets.

Qualitative and quantitative composition

Each tablet contains 100mg of ascorbic acid.

Excipient(s) with known effect: Lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Vitamin C

Ascorbic acid, coupled with dehydroascorbic acid to which it is reversibly oxidised, has a variety of functions in cellular oxidation processes. Ascorbic acid is required in several important hydroxylations, including the conversion of proline to hydroxyproline and appears to have an important role in metal ion metabolism, including the gastrointestinal absorption of iron and its transport between plasma and storage organs.

List of Excipients

Microcrystalline cellulose
Magnesium stearate
Lactose monohydrate
Maize starch
Pregelatinised maize starch
Syrup

Pack sizes and marketing

1. Opaque plastic containers (securitainers) fitted with plastic caps with a packaging inclusion of a silica gel desiccant pack.

Pack sizes are 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 tablets.

2. Opaque plastic containers composed of either high density polypropylene or high density polyethylene with a tamper-evident or child-resistant tamper-evident closure composed of high density polyethylene with a packing inclusion of standard polyether foam or polyethylene or polypropylene-made filler and a silica desiccant pack.

Pack sizes are 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 tablets.

3. Blister packs of aluminium/opaque PVC/PVDC packed in printed boxboard cartons.

Pack sizes are 28, 30, 56, 60, 84, 90 and 112 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Ennogen Pharma Limited, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS

Marketing authorization dates and numbers

PL 40147/0005

11/05/2004

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