AMYDRAMINE PAEDIATRIC SYRUP 120ML

Indications

Approved Uses

Symptomatic relief of cough associated with upper respiratory tract infections/common cold and relief of allergic symptoms such as runny nose and sneezing (e.g., allergic rhinitis).

Off-Label Uses

Not recommended to use this pediatric cough/cold product for insomnia; diphenhydramine is sometimes used off-label for motion sickness or short-term insomnia in older patients, but this specific pediatric syrup should not be used off-label to sedate children.

Dosage & Administration

Dosing by Condition

Children under 2 years: do not use. Children 2 to 5 years: do not use unless directed by a doctor. Children 6 to 11 years: 5 mL to 10 mL every 4 to 6 hours (do not take more than 6 doses in 24 hours).

Initial Dose

Children 2 to 5 years: do not use unless directed by a doctor. Children 6 to 11 years: 5 mL to 10 mL every 4 to 6 hours.

Maintenance Dose

Children 2 to 5 years: do not use unless directed by a doctor every 4-6 hours as needed. Children 6 to 11 years: 5 mL to 10 mL every 4-6 hours as needed.

Maximum Dose

Children 2-5 years: ask a doctor (max 15 mL/24 h if directed); Children 6-11 years: max 30 mL/24 h; ≥12 years: max 60 mL/24 h.

Children's Dosage

Children under 2 years: do not use. Children 2 to 5 years: do not use unless directed by a doctor. Children 6 to 11 years: 5 mL to 10 mL every 4 to 6 hours (do not take more than 6 doses in 24 hours).

How to Take

Shake well before use. Measure the dose with a calibrated oral syringe/medicine spoon/cup (not a household teaspoon). Administer orally; may be given with or without food.

Side Effects

Common Side Effects

Drowsiness/sedation, dizziness, dry mouth/nose/throat, blurred vision, nausea/epigastric upset, constipation, thickened bronchial secretions; paradoxical excitation may occur in children.

Side Effect Frequency

Common: drowsiness/sedation, dizziness, dry mouth (anticholinergic effects); less common/rare: blurred vision, urinary retention, tachycardia/palpitations, paradoxical excitation (especially in children), hypersensitivity reactions.

Safety & Warnings

Warnings & Precautions

Warnings/precautions: may cause marked sedation-avoid alcohol/CNS depressants and supervise children; paradoxical excitation may occur in children; use caution in asthma/COPD or lower respiratory disease, glaucoma/increased intraocular pressure, urinary retention/prostatic hypertrophy, cardiovascular disease/hypertension, hyperthyroidism; do not exceed recommended dose and avoid use in <2 years unless directed by a physician.

Age Restriction

Do not use in children <2 years unless directed by a physician; avoid use in neonates/premature infants.

Drug Interactions

Drug Interactions

Key interactions: MAO inhibitors (and within 14 days) ↑/prolong anticholinergic/CNS effects; CNS depressants (alcohol, benzodiazepines, opioids, sedative-hypnotics) additive sedation/respiratory depression; other anticholinergics (e.g., TCAs, antipsychotics, antiparkinsonian anticholinergics) additive anticholinergic toxicity; other antihistamines additive adverse effects.

Interaction Severity

MAJOR: MAO inhibitors (may intensify/prolong anticholinergic/CNS effects; avoid). MODERATE: other CNS depressants (opioids, benzodiazepines, sedatives, alcohol) causing additive sedation/respiratory depression risk; other anticholinergic drugs (additive anticholinergic toxicity).

Food Interaction

No restriction

Special Populations

Children

Children under 2 years: do not use. Children 2 to 5 years: do not use unless directed by a doctor. Children 6 to 11 years: 5 mL to 10 mL every 4 to 6 hours (do not take more than 6 doses in 24 hours).

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime; no tapering required for short-term use

Overdose

Overdose may cause anticholinergic toxidrome (mydriasis, dry mouth, flushing, hyperthermia, tachycardia, urinary retention), CNS effects (agitation, hallucinations, delirium, seizures, coma), and respiratory depression; management is urgent medical evaluation with supportive care, activated charcoal if appropriate, benzodiazepines for seizures, and physostigmine only in selected severe anticholinergic delirium under expert supervision.

Patient Counseling

Shake well; measure with a proper device (no household spoon). May cause drowsiness or paradoxical excitement-supervise the child and avoid other sedating/antihistamine products (including other diphenhydramine-containing medicines). Do not exceed recommended dose/frequency; avoid use in children <2 years unless directed by a clinician. Seek medical advice if symptoms persist >7 days or are accompanied by fever, rash, breathing difficulty, or worsening cough. Store below 30°C and keep out of reach of children.

Monitoring Requirements

No routine monitoring required for short-term use; monitor for paradoxical CNS excitation in young children

Pharmacology

Mechanism of Action

Diphenhydramine: first-generation H1 receptor antagonist with central penetration causing sedation; also has anticholinergic effects and can suppress cough via central mechanisms. Sodium citrate: alkalinizing agent that can reduce mucus viscosity/irritation and facilitate expectoration (not a classic mucolytic).

Onset of Action

Approximately 15-30 minutes after oral administration (diphenhydramine).

Duration of Effect

4-6 hours.

Half-Life

Diphenhydramine elimination half-life is typically ~2-9 hours in adults; pediatric values are variable and often overlap this range (commonly reported around ~5-9 hours).

Metabolism

Extensive hepatic metabolism (first-pass), mainly via CYP2D6 with contributions from other CYP pathways (e.g., CYP1A2/CYP2C9/CYP2C19; CYP3A4 may contribute).

Excretion

Primarily renal excretion as metabolites in urine; only a small fraction is excreted unchanged (diphenhydramine).

Product Information

Available Dosage Forms

Syrup (oral).

Composition per Dose

Each 5 ml: Diphenhydramine Hydrochloride 7 mg + Sodium Citrate 28.5 mg

Generic Availability

Yes

OTC Alternatives

For allergy symptoms: non-sedating antihistamines such as loratadine or cetirizine (age-appropriate formulations). For cough: guaifenesin (expectorant) or dextromethorphan (antitussive) where age-appropriate; prioritize non-drug measures (fluids, honey if ≥1 year).

Symptom Target

Cough, Runny Nose, Allergy

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 01-06-2026