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FLIDREX COLD&FLU SYRUP 120ML
- Sku : I-002303
Key features
FLIDREX COLD&FLU SYRUP 120ML (Fludrex) is an over-the-counter syrup containing pseudoephedrine hydrochloride 15 mg, paracetamol 120 mg and chlorpheniramine maleate 0.75 mg. It combines a central analgesic/antipyretic (paracetamol), a sympathomimetic nasal decongestant (pseudoephedrine) and a first‑generation H1 antihistamine (chlorpheniramine) to reduce fever and pain, relieve nasal and sinus congestion via vasoconstriction, and diminish histamine‑mediated symptoms. It is indicated for temporary relief of common cold and flu symptoms including fever, headache and body aches, nasal/sinus congestion, runny nose and sneezing. Available OTC in a 120 ml syrup pack.- Brand: FLUDREX
- Active Ingredient: PSEUDOEPHEDRINE HYDROCHLORIDE 15mg, PARACETAMOL 120mg, CHLORPHENIRAMINE MALEATE 0.75mg
- Strength: 120,15,0.75mg
- Dosage Form: Syrup
- Pack Size: 120 ml
- Route: Oral use
- Prescription Status: OTC
- Therapeutic Class: Analgesic
- Pharmacological Group: Anilides (Paracetamol)
- Drug Class: Analgesic/Antipyretic (Anilide) + Nasal Decongestant (Sympathomimetic) + First-generation Antihistamine (Alkylamine)
- Manufacturer: KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES
- Country of Origin: Kuwait
- SFDA Registration No.: 2702256954
- Shelf Life: 36 months
- Storage: store below 25°c
- Symptom Target: Multi-symptom
- Sedating: Yes
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Indications
Approved Uses
Temporary relief of common cold/flu symptoms including fever and pain (headache, body aches), nasal/sinus congestion, runny nose, and sneezing.
Dosage & Administration
Maximum Dose
Adults: do not exceed 4 g/day of paracetamol AND do not exceed 240 mg/day pseudoephedrine; for this specific syrup strength (per 5 mL: paracetamol 120 mg, pseudoephedrine 15 mg, chlorpheniramine 0.75 mg), that corresponds to a maximum of 80 mL/day (paracetamol 1920 mg, pseudoephedrine 240 mg, chlorpheniramine 12 mg). Children 6-11 years: do not exceed 120 mg/day pseudoephedrine (i.e., 40 mL/day of this syrup).
Side Effects
Common Side Effects
Drowsiness/sedation, dizziness, dry mouth, blurred vision, nausea; nervousness/restlessness/insomnia; palpitations and increased heart rate; urinary retention (especially in men with BPH).
Side Effect Frequency
Common: drowsiness/sedation, dizziness, dry mouth, nausea; Common (sympathomimetic-related): nervousness, insomnia; Uncommon/Rare: palpitations/tachycardia, increased blood pressure, urinary retention, blurred vision, skin rash/allergic reactions.
Safety & Warnings
Warnings & Precautions
Do not exceed recommended dose or combine with other paracetamol-containing products; avoid use with MAOIs (or within 14 days); caution in hypertension, ischemic heart disease, diabetes, hyperthyroidism, glaucoma, benign prostatic hyperplasia/urinary retention, hepatic or renal impairment; may cause drowsiness-avoid driving/alcohol/CNS depressants; limit duration and seek care if symptoms persist/worsen.
Age Restriction
Not recommended for children under 6 years (unless specifically directed by a clinician).
Driving Warning
May Cause Drowsiness
Drug Interactions
Drug Interactions
MAO inhibitors (contraindicated; hypertensive crisis risk with pseudoephedrine); other sympathomimetics/decongestants (additive CV/CNS stimulation); CNS depressants including alcohol/sedatives (additive sedation with chlorpheniramine); tricyclic antidepressants (enhanced pressor response to pseudoephedrine); antihypertensives (reduced antihypertensive effect); warfarin (paracetamol at repeated/high doses may increase INR/bleeding risk); other paracetamol-containing products (overdose risk).
Food Interaction
No restriction
Special Populations
Pregnancy
Consult Doctor
Breastfeeding
Consult Doctor
Storage & Patient Advice
Stopping the Medicine
Safe to stop at any time; discontinue once symptoms resolve or if adverse effects occur.
Overdose
Overdose may be life-threatening: paracetamol-early nausea/vomiting/diaphoresis with delayed (24-72 h) hepatotoxicity; pseudoephedrine-hypertension, tachycardia, agitation, arrhythmias, seizures; chlorpheniramine-marked sedation or excitation, anticholinergic toxicity (mydriasis, hyperthermia, urinary retention), seizures. Management: urgent medical care/poison center, consider activated charcoal if early, check paracetamol level and give N-acetylcysteine when indicated, plus supportive/cardiovascular management.
Patient Counseling
Do not exceed the recommended dose/frequency and avoid taking any other paracetamol-containing products. May cause drowsiness-avoid driving/operating machinery; avoid alcohol. Do not use with MAO inhibitors (or within 14 days). Consult a clinician before use if you have hypertension/heart disease, hyperthyroidism, diabetes, glaucoma, or difficulty urinating/BPH, or if pregnant/breastfeeding. Seek medical advice if symptoms persist >7 days, worsen, or are accompanied by high fever, rash, or shortness of breath.
Monitoring Requirements
No routine monitoring for short-term OTC use. Consider monitoring liver function/clinical signs of hepatotoxicity if prolonged use, high-risk patients (hepatic disease, chronic alcohol use), or suspected overdose; monitor blood pressure/heart rate in patients with cardiovascular disease or hypertension if symptomatic.
Pharmacology
Mechanism of Action
Paracetamol: central analgesic/antipyretic via inhibition of central prostaglandin synthesis. Pseudoephedrine: sympathomimetic (primarily alpha-adrenergic) causing nasal mucosal vasoconstriction and decongestion. Chlorpheniramine: first-generation H1 antagonist reducing histamine-mediated symptoms (sneezing/rhinorrhea) with anticholinergic/sedative properties.
Onset of Action
30-60 minutes.
Bioavailability
Paracetamol: 70-90%. Pseudoephedrine: ~100%. Chlorpheniramine: 25-50%.
Metabolism
Paracetamol: hepatic glucuronidation/sulfation with a minor CYP-mediated pathway (notably CYP2E1) producing a reactive metabolite. Pseudoephedrine: minimal hepatic metabolism. Chlorpheniramine: hepatic metabolism (primarily CYP2D6; other CYPs may contribute).
Product Information
Available Dosage Forms
Syrup (oral).
Composition per Dose
Each 5ml contains: 120mg Paracetamol, 15mg Pseudoephedrine Hydrochloride, 0.75mg Chlorpheniramine Maleate.
Generic Availability
Yes
OTC Alternatives
For fever/pain: single-ingredient paracetamol. For congestion: saline nasal spray/irrigation; short-course topical nasal decongestant (e.g., oxymetazoline) if appropriate. For rhinorrhea/sneezing: non-sedating antihistamine (e.g., loratadine) if allergy-predominant.
Symptom Target
Multi-symptom
Sedating
Yes
Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 08-08-2026
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