MEGAFEN® Syrup – Medical Description

Megafen Syrup contains ibuprofen 100 mg per 5 mL, a non-steroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic, and anti-inflammatory properties. Ibuprofen works by inhibiting the production of prostaglandins, substances involved in pain, inflammation, and fever. It is commonly used in pediatric and adult patients for the temporary relief of mild to moderate pain and fever.

Indications

Megafen Syrup may be used for the relief of:

Fever associated with common infections or immunization
Mild to moderate pain
Headache
Toothache and teething pain
Ear pain (as directed by a physician)
Sore throat
Musculoskeletal pain
Minor injuries such as sprains and strains
Symptoms associated with common cold and influenza

Dosage and Administration

Strength: 100 mg ibuprofen per 5 mL.

Pediatric dosing is preferably based on body weight rather than age. The usual dose is:

5–10 mg/kg per dose every 6–8 hours as needed, with a maximum daily dose of 40 mg/kg/day or 4 doses within 24 hours.

Approximate dosing guide for 100 mg/5 mL suspension:

Child Weight	Approximate Age	Dose
10.9–16.3 kg	2–3 years	5 mL
16.4–21.7 kg	4–5 years	7.5 mL
21.8–27.2 kg	6–8 years	10 mL
27.3–32.6 kg	9–10 years	12.5 mL
32.7–43.2 kg	11–12 years	15 mL

Administer every 6–8 hours as needed. Do not exceed 4 doses in 24 hours.

Directions for Use

Shake the bottle well before use.
Use the supplied oral syringe or measuring cup to ensure accurate dosing.
Administer with food or milk if stomach upset occurs.
Use the child's weight whenever possible to determine the dose.

Precautions and Warnings

Use Megafen Syrup with caution in patients with:

History of stomach ulcers or gastrointestinal bleeding
Kidney disease or dehydration
Liver impairment
Asthma that may be triggered by NSAIDs
Known hypersensitivity to ibuprofen, aspirin, or other NSAIDs

Do not use:

In infants under 6 months of age unless directed by a physician.
Concurrently with other ibuprofen-containing products or NSAIDs.
In patients with known allergy to ibuprofen or aspirin-induced asthma.

Seek medical advice if:

Fever persists for more than 3 days.
Pain persists for more than 5 days.
Symptoms worsen or new symptoms develop.

Possible Side Effects

Common side effects may include:

Stomach discomfort
Nausea or vomiting
Heartburn
Dizziness

Rare but serious adverse effects include:

Gastrointestinal bleeding
Severe allergic reactions
Kidney impairment

Storage

Store below 25–30°C according to local labeling.
Keep tightly closed and protected from excessive heat.
Keep out of reach and sight of children.

Patient Disclaimer

This product should be used only as directed by a healthcare professional or according to the product labeling. Do not exceed the recommended dose. Consult a physician or pharmacist before use in children under 6 months of age or in patients with chronic medical conditions. If symptoms persist or worsen, seek medical attention promptly.