PONAC Suspension Ref.[115253] Active ingredients: Mefenamic acid

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Pharmacorp (Pty) Ltd, 29 Victoria Link, Route 21 Corporate Park, Irene, 0178, Pretoria

Product name and form

PONAC SUSPENSION, mefenamic acid 50 mg per 5 ml.

Pharmaceutical Form

An off-white suspension of pourable consistency with a fruity odour and taste.

Qualitative and quantitative composition

Each 5 ml PONAC SUSPENSION contains 50,000 mg mefenamic acid.

Preservatives:

Butyl hydroxybenzoate 0,015% m/v
Methyl hydroxybenzoate 0,03% m/v
Propyl hydroxybenzoate 0,015% m/v

Contains sweetener:

Saccharin sodium 1,000 mg per 5 ml
Sorbitol solution 2,000 ml per 5 ml

For full list of excipients, see section 6.1.

Active Ingredient

Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.

List of Excipients

Citric acid monohydrate
Disodium edetate
Dye lennon white no. 101 (C.I. no. 77891)
Flavour tutti – frutti 60785 – 74
Flavour vanilla 75012 – 33
Guar Gum
Purified water
Simethicone emulsion 30%
Sodium chloride
Sodium citrate
Sodium cyclamate
Sodium lauryl sulphate
Xanthan gum

Preservatives:

Butyl hydroxybenzoate
Methyl hydroxybenzoate
Propyl hydroxybenzoate

Sweeteners:

Saccharin sodium
Sorbitol solution 70%

Pack sizes and marketing

Amber glass bottles containing 100 ml or 200 ml of suspension. Amber PVC bottles containing 100 ml or 200 ml of suspension. The bottles are packed into outer cardboard carton.

Not all packs and pack sizes may be marketed.

Marketing authorization holder

Pharmacorp (Pty) Ltd, 29 Victoria Link, Route 21 Corporate Park, Irene, 0178, Pretoria

Marketing authorization dates and numbers

Y/2.7/192

23 August 1991

Drugs

Drug Countries
PONAC South Africa

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