DIPHAL EXPECTORANT Solution Ref.[50511] Active ingredients: Ammonium chloride Diphenhydramine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: MDI Healthcare CC, 374 Anderson Street, Menlo Park, Pretoria, 0081, RSA

Product name and form

DIPHAL EXPECTORANT (Solution).

Pharmaceutical Form

Solutions.

A clear brown syrupy liquid.

Qualitative and quantitative composition

Each 5 ml contains:

Diphenhydramine Hydrochloride 14 mg

Ammonium Chloride 136 mg

Preservative: Nipastat 0,02% m/v

Contains sugar (sucrose) 1 300 mg per 5 ml.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ammonium chloride
Diphenhydramine

Diphenhydramine is an ethanolamine-derivative antihistamine. It is an antihistamine with anticholinergic and marked sedative effects. It acts by inhibiting the effects on H1-receptors. Diphenhydramine is effective in reducing sleep onset (i.e., time to fall asleep) and increasing the depth and quality of sleep.

List of Excipients

Caramel 4800 (flavour)
Essence of raspberry No. 1 (flavour)
Invert syrup
Menthol (flavour)
Nipastat
Propylene glycol
Purified water
Sodium citrate
Sucrose

Pack sizes and marketing

100 ml round amber PVC bottles with white LDPE screw on or snap-on caps, or 200 ml round amber PVC bottles with white LDPE snap-on caps.

Marketing authorization holder

MDI Healthcare CC, 374 Anderson Street, Menlo Park, Pretoria, 0081, RSA

Marketing authorization dates and numbers

46/10.1/0087

Date of registration: 25 March 2019

Drugs

Drug Countries
DIPHAL EXPECTORANT South Africa

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