FEVADOL SF 160/MG/5/ML SYRUP 145ML

Indications

Approved Uses

Temporary relief of mild-to-moderate pain and reduction of fever (e.g., headache, toothache, sore throat/aches associated with colds/flu).

Off-Label Uses

Adjunct analgesia in osteoarthritis and other musculoskeletal pain (use is common though efficacy may be modest).

Dosage & Administration

Dosing by Condition

Pain/fever: Children: 10-15 mg/kg per dose orally every 4-6 hours as needed (max 60 mg/kg/day; do not exceed 4 doses/24 h). Adults/adolescents ≥50 kg: 500-1000 mg every 4-6 hours as needed (max 4 g/day; lower max in hepatic risk). For this syrup (24 mg/mL): dose volume (mL) = prescribed mg ÷ 24.

Initial Dose

10-15 mg/kg per dose for children; 500-1000mg for adults

Maintenance Dose

10-15 mg/kg every 4-6 hours in children; 500-1000mg every 4-6 hours in adults

Maximum Dose

Children: up to 60 mg/kg/day (typical 10-15 mg/kg per dose every 4-6 hours; max 4 doses/24 h); Adults: max 4000 mg/day.

Children's Dosage

10-15 mg/kg per dose every 4 to 6 hours as required, with no more than four doses in 24 hours. Maximum daily dose: 60 mg/kg.

Dose Adjustment Notes

Renal impairment: if CrCl <30 mL/min, extend dosing interval (e.g., every 6-8 hours) and avoid excessive total daily dose; hepatic impairment/chronic alcohol use/malnutrition/low body weight: use the lowest effective dose and reduce maximum daily dose (often ≤2-3 g/day in adults depending on risk).

How to Take

Shake well before use; measure the dose with an accurate measuring device (oral syringe/cup); administer orally (may be given directly-mixing with a small amount of water/juice is acceptable if needed to aid administration).

Side Effects

Common Side Effects

Uncommon: nausea, vomiting, abdominal discomfort. Rare: rash/urticaria or other hypersensitivity reactions.

Side Effect Frequency

Uncommon: nausea, vomiting, abdominal discomfort. Rare: rash/urticaria or other hypersensitivity reactions. Very rare: serious skin reactions or blood dyscrasias; clinically significant liver/kidney injury is mainly associated with overdose or prolonged high-dose use.

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol (acetaminophen) or excipients; severe hepatic impairment/active liver disease.

Warnings & Precautions

Do not exceed recommended dose or use multiple paracetamol-containing products concurrently; seek medical advice if symptoms persist; use caution (and consider dose/interval adjustment) in hepatic impairment, chronic alcohol use, malnutrition/low glutathione states, dehydration, and renal impairment; overdose can cause severe liver damage.

Age Restriction

Not recommended for routine use in infants <3 months; may be used from 2 months only on medical advice (e.g., post‑immunization fever) with weight-based dosing.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/coumarins (INR may increase with regular/prolonged paracetamol use); alcohol and other hepatotoxic drugs; enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑ hepatotoxicity risk); cholestyramine (↓ absorption if given close together).

Interaction Severity

MAJOR: Chronic/excess alcohol use (increased hepatotoxicity risk). MODERATE: Warfarin (INR may increase with regular/high-dose use over several days), isoniazid (hepatotoxicity risk), enzyme inducers such as rifampicin/carbamazepine/phenytoin (may increase toxic metabolite formation). MINOR: Cholestyramine (reduces absorption if given close together), metoclopramide/domperidone (increase absorption rate).

Food Interaction

No food restrictions; food may delay the rate of absorption but does not meaningfully reduce overall exposure/effect.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Safe

Children

10-15 mg/kg per dose every 4 to 6 hours as required, with no more than four doses in 24 hours. Maximum daily dose: 60 mg/kg.

Elderly

Standard adult dosing is generally appropriate. Consider a lower maximum daily dose in frail elderly patients or those with hepatic risk factors (e.g., do not exceed 3000 mg/day).

Liver Impairment

Mild-moderate hepatic impairment: use with caution and consider reducing total daily dose and/or extending dosing interval; severe hepatic impairment/active liver disease: avoid/contraindicated.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not take a double dose.

Stopping the Medicine

Can be stopped abruptly; no tapering is required. Do not exceed the recommended dose or duration, and seek medical advice if symptoms persist.

Overdose

Early symptoms: nausea, vomiting, diaphoresis, abdominal pain; serious toxicity: hepatocellular injury with rising transaminases and possible liver failure (± renal failure) typically evolving over 24-72 hours; management: urgent medical assessment, consider activated charcoal if within ~1 hour, and administer N‑acetylcysteine (most effective when started within 8-10 hours) plus supportive care.

Patient Counseling

Shake well; measure doses with an oral syringe/cup; leave at least 4 hours between doses and do not exceed 4 doses in 24 hours; avoid taking any other products containing paracetamol; seek urgent help after overdose even if asymptomatic; consult a clinician if fever/pain persists (commonly >3 days in children or >5 days in adults) or if liver disease/chronic alcohol use; store below 30°C and keep out of reach of children.

Monitoring Requirements

No routine monitoring for short-term OTC use; consider liver function monitoring with prolonged/frequent use or in patients with hepatic risk factors (e.g., chronic alcohol use, liver disease, malnutrition) and monitor INR if used regularly with warfarin.

Pharmacology

Mechanism of Action

Analgesic/antipyretic via central inhibition of prostaglandin synthesis (COX activity) and modulation of central pain pathways; antipyresis via action on the hypothalamic thermoregulatory center.

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours.

Half-Life

Approximately 2 hours (typical adult range ~1-3 hours).

Bioavailability

63-89%.

Metabolism

Hepatic; primarily via glucuronidation (45-55%) and sulfation (25-35%); minor CYP2E1/CYP3A4 pathway produces toxic metabolite NAPQI

Excretion

Primarily renal: >90% excreted in urine within 24 hours mainly as glucuronide and sulfate conjugates; ~2-5% excreted unchanged.

Protein Binding

Low/negligible at therapeutic concentrations: ~10-25% (often cited as <20%), increasing in overdose.

Product Information

Available Dosage Forms

For this product: Oral syrup. (Paracetamol in general is also available as tablets/caplets, oral liquid (solution/suspension), suppositories, and IV infusion; availability varies by market/brand.)

Composition per Dose

Each 5ml: 120mg paracetamol

Generic Availability

Yes

OTC Alternatives

Ibuprofen oral suspension (age-appropriate) and other paracetamol oral liquids/tablets (ensuring no duplicate paracetamol-containing products).

Pain Type

General

Nsaid

No

Opioid

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.