KWELLS KIDS Tablet Ref.[49932] Active ingredients: Butylscopolamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB, UK

Product name and form

Kwells Kids 150 microgram tablets.

Pharmaceutical Form

Tablet.

Small white circular, flat faced tablets with bevelled edges. One face is bisected by a score line and the other is plain.

Qualitative and quantitative composition

Hyoscine Hydrobromide: 150 micrograms.

For excipients, see 6.1.

Active Ingredient Description
Butylscopolamine

Butylscopolamine is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.

List of Excipients

Mannitol
Potato starch part dried
Gelatin powder
Aluminium stearate
Saccharin sodium

Pack sizes and marketing

Blister packs made up of 250ยตm opaque white PVC coated with 40 gsm PVDC and 20ยตm hard tempered aluminium foil.

a. Two strips of six tablets in cardboard carton.

b. One strip of twelve tablets in cardboard carton

Pack sizes: 12.

Marketing authorization holder

Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB, UK

Marketing authorization dates and numbers

PL 14017/0300

10/06/1988

Drugs

Drug Countries
KWELLS Ireland, Malta, United Kingdom

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