DULCOLAX PICO Oral solution Ref.[8377] Active ingredients: Sodium picosulfate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Product name and form

Dulcolax Pico Liquid, 5 mg/5 ml, oral solution.

Pharmaceutical Form

Oral solution.

Clear, colourless to yellowish or slightly yellowish-brown, slightly viscous liquid.

Qualitative and quantitative composition

Each 5ml of liquid contains 5 mg sodium picosulfate.

Dulcolax Pico Liquid also contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and ethanol.

For full list of excipients, see section 6.1.

Active Ingredient Description
Sodium picosulfate

Sodium picosulfate is a locally acting laxative from the triarylmethane group, which after bacterial cleavage in the colon, has a dual-action with stimulation of the mucosa of both the large intestine and of the rectum.

List of Excipients

Sodium carboxymethylcellulose
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Glycerol
Tutti frutti flavour
Saccharin sodium
Ethanol 96%
0.1 M sodium hydroxide
Purified water

Pack sizes and marketing

Amber glass bottles with aluminium ROPP caps.

Pack sizes of 90 and 500 ml.

Amber glass bottles with polypropylene tamper-evident closure with expanded polyethylene (coated with LDPE) liner.

Pack sizes of 100, 250 and 300 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Marketing authorization dates and numbers

PL 04425/0714

16/09/2005

Drugs

Drug Countries
DULCOLAX PICO Ireland, United Kingdom

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