Directions for use Adults and children 12 years and over Directions for use must be as shown in the table below. Dosage form Single dose Dose interval Maximum daily dose and strength 500 mg tablets, 1 2 tablets, 4-6 hours, 8 tablets in 24 hours – capsules, oral capsules or as necessary powder sachets 600 mg oral 1 sachet every 4-6 hours, 6 sachets in 24 hours powder as necessary 1000 mg oral 1 sachet every 4-6 hours, 4 sachets in 24 hours powder as necessary For soluble and effervescent tablets and oral powders, appropriate instructions for preparation of the dose form must be included. Liquid dose products for children 1 month to 12 years Dosages must be as shown in the table below. Age Average body Single dose Single dose Single dose weight (kg) (mL) (mL) (mL) 24 mg/mL oral 48 mg/mL oral 100 mg/mL liquid liquid oral liquid 1 3 months 4 6 - - 0.6 0.9 mL – – – 3 6 months 6 8 - - 0.9 1.2 mL – – – 6 12 months 8 10 - - 1.2 1.5 mL – – – 1 2 10 12 6 8 mL 3 4 mL 1.5 1.8 mL – – – – – 2 3 years 12 14 8 9 mL 4 mL - – – – 3 4 years 14 16 9 10 mL 4 5 mL - – – – –
Directions for use Adults and children 12 years and over Directions for use must be as shown in the table below. Dosage form and strength Single dose Dose interval Maximum daily dose 500 mg tablets, capsules, oral powder 1 – 2 tablets, capsules or sachets 4-6 hours, as necessary 8 tablets in 24 hours 600 mg oral powder 1 sachet every 4-6 hours, as necessary 6 sachets in 24 hours 1000 mg oral powder 1 sachet every 4-6 hours, as necessary 4 sachets in 24 hours For soluble and effervescent tablets and oral powders, appropriate instructions for preparation of the dose form must be included. Liquid dose products for children 1 month to 12 years Dosages must be as shown in the table below. Age Average body weight (kg) Single dose (mL) 24 mg/mL oral liquid Single dose (mL) 48 mg/mL oral liquid Single dose (mL) 100 mg/mL oral liquid 1 – 3 months 4 – 6 - - 0.6 – 0.9 mL 3 – 6 months 6 – 8 - - 0.9 – 1.2 mL 6 – 12 months 8 – 10 - - 1.2 – 1.5 mL 1 – 2 10 – 12 6 – 8 mL 3 – 4 mL 1.5 – 1.8 mL 2 – 3 years 12 – 14 8 – 9 mL 4 mL - 3 – 4 years 14 – 16 9 – 10 mL 4 – 5 mL -
consult-otc-product-n2-130618-paracetamol.docx