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

4.1. Therapeutic indications

DIPHAL EXPECTORANT is indicated for the alleviation of cough in adults and children 6 years and older.

4.2. Posology and method of administration

A maximum of four doses per day should not be exceeded.

Shake the bottle before use.

Adults: one to two medicine measures (5 to 10 ml) every three to four hours.

Children 6 to 12 years: half to one medicine measure (2,5 to 5 ml) every four hours.

Paediatric population: The safety in children under 6 years has not been established (see section 4.3).

4.9. Overdose

Symptoms of hypernatraemia may include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, delirium, hyperpnoea and respiratory arrest. Other symptoms of overdosage are gastrointestinal upset, drowsiness, hypochloraemic acidosis and hypokalaemia.

Diphenhydramine hydrochloride:

Overdosage may be fatal, especially in children in whom main symptoms are central nervous system stimulation and antimuscarinic effects, including ataxia, excitement, hypotension, drowsiness, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia, respiratory collapse, death may occur from respiratory failure.

Treatment is symptomatic and supportive.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store in a cool place, at or below 25°C. Protect from light.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

No special requirements.

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