GSK Consumer Healthcare


GSK Consumer Healthcare
Full Prescribing Info
Paracetamol's molecular formula is C8H9NO2 and its relative molecular formula is 151.2.
Pharmacology: Pharmacodynamics: Paracetamol is an analgesic and antipyretic. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system.
Pharmacokinetics: Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Binding to the plasma proteins is minimal at therapeutic concentrations. Paracetamol is metabolized in the liver and excreted in the urine mainly as glucuronide and sulfate conjugates. Less than 5% is excreted as unmodified paracetamol.
Used in the relief of mild to moderate fever and pain: Headache, Migraine, Muscle ache, Sore throat, Musculoskeletal pain, Pain after dental procedure/tooth extraction, Toothache, Fever and pain associated with vaccination/immunization, Earache/otalgia, Respiratory tract infections including cold and flu.
Dosage/Direction for Use
To be taken orally every 4-6 hours.
Minimum dosing interval: 4 hours.
Do not take more than 4 doses in any 24 hour period.
Do not take for more than 3 days without asking the doctor.
Dose may be based on weight or age; use weight if it is known, otherwise use age: See table.

Click on icon to see table/diagram/image

Do not exceed stated dose.
Maximum Daily Dosage: 60 mg/kg presented in divided doses of 10-15 mg/kg throughout the 24 hour period.
Use the smallest dose that patient needs to treat the symptoms and use the medicine for the shortest period of time necessary.
Missed dose: If fever/pain persists, give the missed dose and ensure 4 hours interval before giving the next dose.
Paracetamol (Calpol) overdose may cause liver failure which may require liver transplant or lead to death. Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity.
When patient has taken more than the recommended dosage: Immediate medical management is required in the event of overdose, even if symptoms of overdose are not present.
Administration of N-acetylcysteine or methionine may be required.
If overdose is confirmed or suspected, seek immediate advice from the Poison Centre and go to the nearest Emergency Medical Centre for management and expert treatment.
Contraindicated in patient with known hypersensitivity to paracetamol, or any other component of the formulation.
Special Precautions
Do not take more than the recommended dose as it may cause serious harm to the liver.
If child has been diagnosed with liver or kidney impairment, seek medical advice before giving the medication.
Check with the doctor before use if patient: has liver or kidney problems or is underweight or malnourished.
Patient may need to avoid using this product altogether or limit the amount of paracetamol that the patient takes if the patient has a severe infection as this may increase the risk of metabolic acidosis.
In patients with glutathione depleted states such as sepsis, the use of Paracetamol may increase the risk of metabolic acidosis.
Signs of metabolic acidosis include: deep, rapid, difficult breathing; feeling sick (nausea), being sick (vomiting); loss of appetite.
When to consult a doctor: If patient has any difficulties or do not understand the instructions ask a doctor or pharmacist.
If symptoms persist seek medical advice.
Adverse Reactions
Thrombocytopenia, anaphylaxis, cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens-Johnson Syndrome, bronchospasm in patients sensitive to aspirin and other NSAIDs, hepatic dysfunction.
Drug Interactions
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Should not be used with other Paracetamol containing products.
Caution For Usage
Shake well before use.
Store at temperatures not exceeding 30°C.
Keep out of direct light exposure.
MIMS Class
Analgesics (Non-Opioid) & Antipyretics
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Oral susp 120 mg/5 mL (strawberry-flavored, pink color, alcohol-free with a strawberry odor) x 60 mL, 120 mL. 250 mg/5 mL (orange-flavored, alcohol-free with an odor characteristics of oranges) x 60 mL, 100 mL. Infant oral drops 100 mg/mL (orange-flavored, brownish color, alcohol-free) x 10 mL.
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