Infacetamol 100 mg/ml, oral solution for children and infants, 50 ml

Infacetamol 100 mg/ml is an oral solution for infants and children from birth up to 32 kg (approximately up to 10 years). It provides effective relief from fever and mild to moderate pain of various origins, including teething pain, pain after vaccinations, and colds or flu-like symptoms. The solution is clear, slightly pink, and has a pleasant strawberry scent. Its active ingredient, paracetamol, is a proven analgesic and antipyretic agent.

Indications

• Fever of various origins
• Mild to moderate pain: teething, post-vaccination, colds, or flu-like symptoms
• For children weighing up to 32 kg

Composition

• Active substance: paracetamol 100 mg per 1 ml
• Excipients: propylene glycol (E1520) 7.68 g, glycerol, macrogol 600, sodium saccharin, strawberry flavor PHL-132200 (propylene glycol, aromatic substances), purified water

Dosage

• Dose based on body weight. Approximate daily dose: 60 mg/kg/day, divided into 4–6 doses
• For 15 mg/kg every 6 hours or 10 mg/kg every 4 hours, follow dosing tables for age and weight
• Maximum total daily dose: 60 mg/kg in children under 12 years
• Administer orally using pipette (for <3 years) or oral syringe (for ≥3 years)
• Intervals between doses should not be shorter than 4 hours; include night-time doses

For renal or hepatic impairment, dose adjustments and extended intervals are recommended. In case of recurrent or high fever (>39°C), worsening symptoms, or persistence >2 days, consult a doctor.

Contraindications

• Hypersensitivity to paracetamol or any excipients

Warnings and Precautions

• Do not exceed recommended dose
• Use caution in chronic malnutrition, liver disease (including Gilbert’s syndrome), severe hepatic impairment, renal failure, heart or lung disease, anemia, G6PD deficiency, dehydration, or chronic alcoholism
• Avoid concomitant use of other paracetamol-containing products
• Long-term or frequent use without supervision may be harmful

Side Effects

Rare: general malaise, hypotension, increased liver enzymes. Very rare: liver damage (jaundice) with high doses or long-term use, hypoglycemia, cloudy urine, kidney effects, skin rash, hives, anaphylactic shock, blood cell changes (neutropenia, leukopenia), severe skin reactions.

Storage

Store below 25°C. Keep out of sight and reach of children. Do not use after expiry date. Once opened, use within 6 months.

Package Contents

50 ml bottle of Infacetamol oral solution with pipette or oral syringe for accurate dosing

Keywords

Infacetamol, children's paracetamol, oral solution, infant paracetamol, fever relief, pain relief, analgesic, antipyretic, strawberry flavor, 100 mg/ml, medicine for children