EXYLIN PAEDIATRIC SYRUP 100ML

Indications

Approved Uses

Symptomatic relief of allergy/common-cold upper respiratory symptoms such as runny nose (rhinorrhea), sneezing, and nasal/throat irritation; may also help associated cough due to antihistamine/soothing effect.

Off-Label Uses

Short-term insomnia (adults), motion sickness/vertigo-related nausea, and treatment of acute dystonic reactions/drug-induced parkinsonism (adjunct/alternative when anticholinergic therapy is needed).

Dosage & Administration

Dosing by Condition

Dose is product-specific and should follow the label; in general for diphenhydramine immediate-release for allergy/cold symptoms: Children 2-5 years: 6.25 mg every 4-6 h (max 4 doses/24 h); Children 6-11 years: 12.5-25 mg every 4-6 h (max 4 doses/24 h); ≥12 years: 25-50 mg every 4-6 h (max 300 mg/day). Do not use in children <2 years unless directed by a clinician.

Maintenance Dose

Children 2-5 years: 6.25 mg every 4-6 hours as needed; max 37.5 mg daily (PO); Children 6-11 years: 12.5 to 25 mg every 4-6 hours as needed; max 150 mg/day (PO)

Maximum Dose

Maximum diphenhydramine (immediate-release) daily dose: children 2 to <6 years: 37.5 mg/day; children 6 to <12 years: 150 mg/day; ≥12 years/adults: 300 mg/day (all divided doses).

Dose Adjustment Notes

Use caution and consider lower doses in hepatic impairment and in older adults due to increased sensitivity to sedation/anticholinergic effects; renal impairment generally does not require specific adjustment but warrants caution with repeated dosing.

How to Take

Shake well before use; administer orally using an accurate measuring device (oral syringe/cup); may be taken with or without food; do not exceed the labeled dose/frequency and avoid concomitant sedatives/alcohol.

Side Effects

Common Side Effects

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

Side Effect Frequency

Frequency not reliably classifiable into fixed % bands for this OTC cough/cold combination; clinically expected: common-sedation/drowsiness and anticholinergic effects (dry mouth, dizziness); less common/rare-paradoxical excitation (especially in children), urinary retention, blurred vision, palpitations/tachycardia, hypotension, confusion, seizures (overdose).

Safety & Warnings

Contraindications

Hypersensitivity to diphenhydramine (or other ethanolamine antihistamines) or menthol/excipients; use in premature infants and neonates; concomitant use with MAO inhibitors (or within 14 days of stopping); acute asthma attack/lower respiratory tract disease (including acute exacerbation); narrow-angle glaucoma; urinary retention (including due to prostatic hypertrophy); pyloroduodenal obstruction/stenosing peptic ulcer.

Warnings & Precautions

May cause marked drowsiness/dizziness-avoid driving/operating machinery; avoid alcohol and other sedatives; do not exceed recommended dose or combine with other antihistamine-containing products; not for children <2 years; use caution in asthma/COPD or other lower respiratory disease, narrow-angle glaucoma/increased intraocular pressure, urinary retention/prostatic hypertrophy, pyloroduodenal obstruction, cardiovascular disease/hypertension, hyperthyroidism; avoid with MAO inhibitors; paradoxical excitation may occur in young children.

Age Restriction

Not recommended for children under 2 years of age. Do not use in children 2 to 5 years unless directed by a doctor. Use with caution in children 6 to 11 years.

Drug Interactions

Interaction Severity

MAJOR: other CNS depressants (alcohol, opioids, benzodiazepines, sedative-hypnotics) due to additive sedation/respiratory depression risk; MODERATE: other anticholinergics (e.g., TCAs, some antipsychotics) due to additive anticholinergic toxicity; MODERATE/AVOID: MAO inhibitors may intensify/prolong anticholinergic/CNS effects.

Special Populations

Kidney Impairment

No specific renal dose adjustment is defined; use with caution in severe renal impairment (monitor for increased sedation/anticholinergic effects).

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep away from light. Keep out of reach of children.

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose.

Stopping the Medicine

Safe to stop anytime

Overdose

Symptoms: prominent anticholinergic toxidrome (mydriasis, dry mouth, flushing, hyperthermia, tachycardia, urinary retention, ileus), CNS effects ranging from agitation/hallucinations/delirium and seizures (often in children) to coma/respiratory depression; possible QRS/QT abnormalities/arrhythmias. Management: urgent medical evaluation; activated charcoal if early and airway protected; supportive care (airway/ventilation, IV fluids, temperature control), benzodiazepines for seizures/agitation; consider sodium bicarbonate for wide QRS; physostigmine may be considered for severe anticholinergic delirium in selected cases under expert guidance.

Patient Counseling

May cause marked drowsiness-avoid driving/activities requiring alertness; avoid alcohol and other sedating/anticholinergic medicines and do not combine with other diphenhydramine-containing products; use an accurate measuring device and do not exceed labeled frequency; do not use in children <2 years unless directed by a clinician; seek advice if breathing problems (e.g., asthma/wheezing), urinary retention, severe sedation, or paradoxical agitation occur; store below 30°C (SFDA).

Monitoring Requirements

Baseline creatinine levels should be obtained for pediatric patients. All patients should be screened for mental alertness and relief of symptoms. Clinicians should monitor patients for adverse anticholinergic effects such as sedation, constipation, and urinary retention.

Pharmacology

Mechanism of Action

Diphenhydramine competitively antagonizes peripheral and central H1 receptors, reducing histamine-mediated allergy symptoms and causing sedation; it can reduce cough via central sedative/antitussive effects. Menthol activates TRPM8 receptors producing a cooling sensation and mild local anesthetic/soothing effect in the upper airway.

Duration of Effect

4-6 hours.

Half-Life

Variable; commonly ~4-9 hours in adults, and may be shorter in children (often reported around ~5 hours but variable).

Excretion

Primarily renal excretion as metabolites (urine), with only small amounts excreted unchanged.

Protein Binding

Approximately 80-85% (diphenhydramine)

Product Information

Available Dosage Forms

Syrup

Generic Availability

Yes

OTC Alternatives

For allergic rhinitis symptoms: non-sedating antihistamines such as loratadine or cetirizine (age-appropriate formulations). For cough due to cold (where appropriate by age): dextromethorphan-containing products may be used in older children/adults; saline/honey (age-appropriate) are non-drug options.

Symptom Target

Cough, Runny Nose, Allergy

Sedating

Yes

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