PEPTI-CALM Oral suspension Ref.[27612] Active ingredients: Bismuth subsalicylate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: The Boots Company PLC, 1 Thane Road West, Nottingham NG2 3AA Trading as: BCM

Product name and form

Pepti-Calm 525.6mg/30ml Oral Suspension or Almus Pepti-Calm Suspension Bismuth Subsalicylate 525.6mg/30ml.

Pharmaceutical Form

Oral suspension.

Thick pink suspension.

Qualitative and quantitative composition

Active ingredient mg/30ml
Bismuth subsalicylate 525.6

For excipients, see 6.1.

Active Ingredient Description
Bismuth subsalicylate

Bismuth subsalicylate is a derivative of salicylic acid, with anti-inflammatory and bactericidal action. Bismuth subsalicylate has weak antacid properties. Bismuth subsalicylate is used as an antacid and antidiarrheal, and to treat temporary discomfort of the stomach and gastrointestinal tract, such as nausea, heartburn, indigestion, upset stomach, and diarrhea. Bismuth subsalicylate may exert its antidiarrhoeal action not only by stimulating absorption of fluid and electrolytes across the intestinal wall but also when hydrolysed to salicylic acid, by inhibiting synthesis of a prostaglandin responsible for intestinal inflammation and hypermotility.

List of Excipients

Maltitol liquid
Glycerin
Dispersible cellulose (containing microcrystalline cellulose and sodium carboxymethylcellulose)
Xanthan gum
Citric acid monohydrate
Sodium citrate
Sodium benzoate
Rootbeer flavour (containing polypropylene glycol)
Carmoisine Edicol E (E122)
Purified water

Pack sizes and marketing

A 150ml, 180ml or 300ml white flint glass bottle with a roll on aluminium closure and expanded polyethylene liner.

Marketing authorization holder

The Boots Company PLC, 1 Thane Road West, Nottingham NG2 3AA
Trading as: BCM

Marketing authorization dates and numbers

PL 00014/0615

Date of first authorisation: 02 November 2000

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