Finished product reference

Acetaminophen / Diphenhydramine / Phenylephrine

Syrup · Oral · 160 mg/12.5 mg/2.5 mg/5mL · 200 mL

List code
52274
Pharmacologic class
Combination cold preparation (analgesic-antipyretic, sedating antihistamine, decongestant)

What it is and how it works

Paracetamol relieves pain and fever; diphenhydramine is a sedating H1-antihistamine with antimuscarinic and mild antitussive effects; phenylephrine is an alpha-1 agonist that reduces nasal congestion.

Indications

Short-term relief of cold and influenza symptoms such as fever, aches, nasal congestion, rhinorrhoea and cough, particularly at night.

Contraindications

Hypersensitivity to any component; severe hypertension or coronary disease; use with MAO inhibitors; severe hepatic impairment; young children.

Warnings and precautions

Marked drowsiness; avoid alcohol, other sedatives and driving. Avoid other paracetamol-containing products. Caution in glaucoma, prostatic hypertrophy, urinary retention, hyperthyroidism, diabetes and in the elderly.

Pregnancy

Generally avoided in pregnancy unless advised by a physician.

Storage and supply

Store below 25 °C, protected from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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