AMYDRAMINE EXPECTORANT SYRUP SUGAR FREE 120ML

Indications

Approved Uses

Symptomatic relief of cough associated with upper respiratory tract infections/common cold where an antihistamine/antitussive is appropriate, and relief of allergic symptoms (e.g., rhinitis) where diphenhydramine is indicated.

Off-Label Uses

Diphenhydramine (the active ingredient) is used off-label for short-term insomnia and for prevention/treatment of motion sickness; acute dystonic reactions are treated with diphenhydramine in clinical settings (typically injectable), not with this expectorant syrup product.

Dosage & Administration

Dosing by Condition

Use per local product label; typical diphenhydramine-containing cough/allergy syrup dosing is: Adults and ≥12 years: 10 mL every 4-6 hours as needed (max 6 doses/24 h). Children 6-11 years: 5 mL every 4-6 hours as needed (max 6 doses/24 h). Children 2-5 years: 2.5 mL every 4-6 hours as needed (max 6 doses/24 h). Do not use in children <2 years unless specifically directed by a clinician.

How to Take

Shake well before use. Measure doses with a calibrated measuring spoon/cup or oral syringe. May be taken with or without food; if stomach upset occurs, take with food. Use the lowest effective dose for the shortest duration and do not exceed the labeled maximum daily dose.

Side Effects

Common Side Effects

Drowsiness/sedation, dizziness, dry mouth/nose/throat, blurred vision, constipation, nausea/epigastric upset, urinary retention, and impaired coordination (especially with alcohol/CNS depressants).

Side Effect Frequency

Common/very common: drowsiness/sedation and anticholinergic effects (dry mouth, dizziness); Other common: impaired coordination, blurred vision, constipation, nausea/epigastric discomfort; Less common/uncommon: paradoxical excitation (especially in children), palpitations, hypotension, urinary retention/hesitancy.

Safety & Warnings

Contraindications

Hypersensitivity to diphenhydramine (or any component); neonates and premature infants; breastfeeding; concomitant use of MAO inhibitors (or within 14 days); narrow-angle glaucoma; urinary retention/prostatic hypertrophy; pyloroduodenal obstruction/stenosing peptic ulcer.

Warnings & Precautions

May cause significant drowsiness-avoid driving/alcohol/CNS depressants; use caution in asthma/COPD, glaucoma, urinary retention/BPH, cardiovascular disease, hyperthyroidism, seizure disorders; paradoxical excitation may occur in children; avoid use in children <2 years; older adults are at higher risk of confusion/falls due to anticholinergic effects; do not exceed recommended dosing.

Age Restriction

Not recommended in children under 2 years (and contraindicated in neonates/premature infants).

Drug Interactions

Drug Interactions

MAO inhibitors; alcohol; other CNS depressants (e.g., benzodiazepines, opioids, sedative-hypnotics); other antihistamines; anticholinergic drugs (including TCAs and some antipsychotics).

Interaction Severity

MAJOR: Alcohol and other CNS depressants (e.g., opioids, benzodiazepines) due to additive sedation/respiratory depression; concomitant sedating antihistamines. MODERATE: Other anticholinergics (e.g., TCAs, antipsychotics) increasing anticholinergic burden; MAOIs may enhance/prolong anticholinergic/CNS effects-avoid or use only with medical advice.

Food Interaction

No restriction

Storage & Patient Advice

Missed Dose

If used on a schedule, take the missed dose when remembered unless it is close to the next dose; then skip and resume the regular schedule. Do not double doses.

Stopping the Medicine

May be stopped at any time when no longer needed; no taper is required.

Overdose

Symptoms: marked drowsiness or agitation (esp. children), confusion, hallucinations/delirium, anticholinergic signs (dry mouth, mydriasis, tachycardia, urinary retention, flushing), seizures, arrhythmias/QT prolongation, respiratory depression, coma; Management: urgent medical care/poison center, activated charcoal if appropriate, supportive care (airway/ventilation, benzodiazepines for seizures), ECG monitoring; physostigmine may be considered for severe anticholinergic delirium in selected cases under expert supervision.

Patient Counseling

May cause marked drowsiness and impaired coordination-avoid driving/operating machinery. Avoid alcohol and other sedatives; do not combine with other products containing diphenhydramine/antihistamines. Measure doses accurately and shake well. Do not use in children <2 years unless directed by a clinician. Seek medical advice if symptoms persist >7 days, worsen, or are accompanied by fever, rash, or breathing difficulty. Sugar-free; store below 25°C and keep out of reach of children.

Monitoring Requirements

No routine monitoring required for short-term OTC use

Pharmacology

Mechanism of Action

Diphenhydramine is a first-generation H1 antihistamine (inverse agonist) that reduces histamine-mediated symptoms and can suppress cough via central effects; it also has anticholinergic and sedative activity. Sodium citrate acts as an alkalinizing agent that can reduce mucus viscosity and facilitate expectoration.

Onset of Action

15-60 minutes.

Duration of Effect

4-7 hours.

Metabolism

Diphenhydramine: extensive hepatic metabolism (primarily CYP2D6; also other CYPs such as CYP1A2/CYP2C9/CYP2C19/CYP3A4 reported) via N-demethylation and oxidative pathways; Sodium citrate: metabolized in the liver and peripheral tissues to bicarbonate as part of normal citrate metabolism.

Excretion

Diphenhydramine: primarily renal excretion as metabolites (with only a small fraction as unchanged drug); Sodium citrate: metabolized to bicarbonate/CO2 and ultimately excreted mainly via the kidneys as bicarbonate/alkali load (with CO2 eliminated via lungs).

Product Information

Available Dosage Forms

Syrup (oral).

Generic Availability

Yes

Symptom Target

Cough, Allergy, Runny Nose

Sedating

Yes

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