NORMACOL Granules Ref.[49824] Active ingredients:

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

Product name and form

Normacol 62% w/w Granules.

Pharmaceutical Form

Granules.

White irregular shaped granules.

Qualitative and quantitative composition

Each gram of NORMACOL Granules contains 0.62g of Sterculia BP (62% w/w).

Each sachet contains 4.34g of Sterculia BP.

Excipient(s) with know effect:

Contains 1.7g of sucrose and 28.7mg of sodium per 7g sachet.
Contains 1.0g of sucrose and 16.8mg of sodium per 5ml spoonful.

For a full list of excipients, see 6.1.

List of Excipients

Sucrose
Talc
Sodium hydrogen carbonate
Hard paraffin
Titanium dioxide (E171)
Vanillin

Pack sizes and marketing

Sachet: Laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper. Each sachet contains 7g of white granules supplied in boxes of 2,7 or 60 sachets.

Carton lining: laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper. Lined carton of 500g of white granules.

Not all pack sizes may be marketed.

Marketing authorization holder

Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

Marketing authorization dates and numbers

PA1336/007/001

Date of first authorisation: 25 September 1984
Date of last renewal: 25 September 2009

Drugs

Drug Countries
NORMACOL Hong Kong, Ireland, Netherlands, New Zealand, Tunisia

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