DENTINOX INFANT COLIC DROPS Oral suspension Ref.[49653] Active ingredients: Simethicone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Dendron Brands Limited, 94, Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ, United Kingdom

Product name and form

Dentinox Infant Colic Drops.

Pharmaceutical Form

Oral suspension.

Translucent white liquid.

Qualitative and quantitative composition

Activated Dimeticone 42.00 mg/5ml

Methyl parahydroxybenzoate E218 0.2183 %w/w
Ethyl parahydroxybenzoate E214 0.0496 %w/w
Propyl parahydroxybenzoate E216 0.0321 %w/w

For all excipients, see 6.1.

Active Ingredient Description
Simethicone

Simethicone is a chemically inert, non-systemic gastric defoaming agent that works by altering the elasticity of interfaces of mucus-embedded bubbles in the gastrointestinal tract. The gas bubbles are thus broken down or coalesced and in this form gas is more easily eliminated through eructation or passing flatus.

List of Excipients

Purified water
Sucrose
Carbomer
Dill oil
Sodium hydroxide
Methyl parahydroxybenzoate E218
Ethyl parahydroxybenzoate E214
Propyl parahydroxybenzoate E216

Pack sizes and marketing

Pack size 100ml:

100ml – HDPE round bottle with a jay cap tamper evident closure, with 2.5ml oral dosing syringe.

Pack size 2.5ml:

Sample sachets:

40gsm craft paper, 10 gsm polyethylene, 8gsm aluminium foil and 30gsm surlyn.

Not all pack sizes may be marketed.

Marketing authorization holder

Dendron Brands Limited, 94, Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ, United Kingdom

Marketing authorization dates and numbers

PL 52731/0004

29th November 1976 / 09th September 2008

Drugs

Drug Countries
DENTINOX INFANT Hong Kong, Ireland, United Kingdom

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