Dafalgan 500 mg Paracetamol for Pain and Fever, 16 capsules, available at our organic pharmacy to relieve pain and fever. Share your feedback on usage instructions and dosage with our partner; reviews are verified after your purchase.
For warnings, precautions, and contraindications, please refer to the package insert.
Dafalgan 500 mg Paracetamol 16 capsules is an analgesic and antipyretic medication indicated for the treatment of mild to moderate pain and fever. It can be used by adults and children weighing at least 27 kg, or approximately 8 years of age and older.
Its active ingredient, acetaminophen, helps relieve pain and reduce fever. This medication can be taken, for example, for headaches, toothaches, muscle aches, flu-like symptoms, or painful periods.
Available in capsule form, it is easy to swallow with a glass of water. Each capsule contains 500 mg of acetaminophen, allowing the dose to be adjusted according to weight, age, and the severity of symptoms.
The lowest effective dose should always be used for the shortest possible time. A dose of 1,000 mg (2 capsules) should only be used by individuals weighing at least 50 kg when pain or fever is not sufficiently relieved by a 500 mg dose.
Before each dose, check that other medications you are taking do not contain acetaminophen. This precaution is essential to avoid an acetaminophen overdose, which can cause serious liver damage.
For people who prefer an effervescent form or who have difficulty swallowing capsules, Dafalgan 1000 mg Paracetamol (8 effervescent tablets ) may be a suitable alternative for adults and adolescents weighing at least 50 kg.
Dafalgan 500 mg Paracetamol, 16 capsules, is taken by mouth. The capsules should be swallowed whole with a glass of water.
Use the lowest effective dose for the shortest possible time. The dosage should be adjusted according to the patient’s weight.
Only on medical advice and in the absence of risk factors may the maximum dose be increased to 8 capsules per day (4,000 mg) for patients weighing at least 50 kg.
In cases of mild to moderate liver disease, chronic alcoholism, or Gilbert’s syndrome, the daily dose should not exceed 4 capsules, or 2,000 mg of acetaminophen.
In cases of renal insufficiency, the dose and the interval between doses must be adjusted under medical supervision.
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Precautions
The active ingredient is:
Paracetamol ............................................................................. 500 mg
Per capsule
The other ingredients are:
Magnesium stearate, gelatin, azorubine (E122).
Packaging:
Box of 16 red and white capsules, each containing 500 mg of acetaminophen.
Before taking Dafalgan 500 mg, we recommend that you check the ingredients of all medications used for pain, fever, colds, or flu-like symptoms, as several products may contain acetaminophen. Keep track of when you take the medication to ensure you follow the recommended dosing intervals, and always start with a single capsule when appropriate for your weight. Taking 2 capsules should be reserved for people weighing at least 50 kg when 500 mg is not sufficient. Persistent pain or a prolonged fever requires medical advice rather than increasing the dose on your own.
At what weight can I take Dafalgan 500 mg Paracetamol 16 capsules?
It can be used by adults and children weighing at least 27 kg, or approximately 8 years of age and older. The dose and the interval between doses depend on body weight.
How much Dafalgan 500 mg can I take per day?
You may take up to 4 capsules per day if you weigh between 27 and 40 kg, and up to 6 capsules per day if you weigh 41 kg or more. For adults weighing at least 50 kg, a dose of 8 capsules per day is permitted only under medical supervision and in the absence of risk factors.
When can I take two Dafalgan 500 mg capsules?
You may take 2 capsules per dose only if you weigh at least 50 kg and if a 500 mg dose has not sufficiently relieved the pain or fever. An interval of at least 4 hours must be observed.
How long can I use Dafalgan 500 mg without consulting a doctor?
It should not be used for more than 5 days to treat pain or more than 3 days to treat a fever without medical advice. Consult a doctor if symptoms persist or worsen.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 22/07/2025
Drug name
DAFALGAN 500 mg, capsule
Paracetamol
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should consult your doctor if pain persists for more than 5 days, or fever for more than 3 days, or in the event of insufficient efficacy or any other sign.
What does this leaflet contain?
1. What is DAFALGAN 500 mg, capsule and what is it used for?
2. What do I need to know before taking DAFALGAN 500 mg, capsule?
3. How do I take DAFALGAN 500 mg, capsule?
4. What are the possible side effects?
5. How to store DAFALGAN 500 mg, capsule?
6. Package contents and other information.
1. WHAT IS Dafalgan 500 mg, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OTHER ANALGESICS and ANTIPYRETIC-ANILIDES - ATC code: N02BE01.
DAFALGAN 500 mg, capsule contains paracetamol. Paracetamol is an analgesic (pain reliever) and an antipyretic (fever reducer).
Paracetamol is indicated for adults and children weighing 27 kg or more (approximately 8 years of age) to reduce fever and/or relieve mild to moderate pain (for example: headaches, flu-like symptoms, toothache, aches and pains, painful menstruation, painful bouts of arthrosis).
Carefully read "Dosage" in section 3.
For children under 27 kg, there are other paracetamol presentations: ask your doctor or pharmacist for advice.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING Dafalgan 500 mg, capsule?
Never take Dafalgan 500 mg, capsule:
- if you are allergic to paracetamol or any of the other ingredients listed in section 6.
- if you have severe liver disease.
If in doubt, ask your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking DAFALGAN 500 mg, capsule:
- if you are an adult weighing less than 50 kg,
- if you have kidney or liver disease,
- if you are elderly,
- if you regularly drink alcohol or have recently stopped drinking alcohol,
- in cases of chronic malnutrition, fasting, emaciation, anorexia or cachexia (low liver glutathione reserves or deficiency),
- dehydration,
- Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (may lead to hemolytic anemia),
- Gilbert's syndrome (non-hemolytic familial jaundice).
In the event of acute viral hepatitis, discontinue treatment and consult your doctor.
Long-term, incorrect and/or high-dose use of this drug in patients with chronic headaches may cause headaches to develop or worsen. Do not increase your dose of analgesics, but consult your doctor.
During treatment with DAFALGAN 500 mg, capsule, inform your doctor immediately:
- If you have any serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you are malnourished, chronically alcoholic or also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients who regularly take paracetamol for a prolonged period or who take paracetamol in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid, deep breathing, drowsiness, nausea and vomiting.
Children and adolescents
In children being treated with paracetamol, the combination with another fever-reducing drug (antipyretic) is justified only if it is effective. The combination should only be initiated and monitored by a physician.
Other drugs and DAFALGAN 500 mg, capsule
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including medicines obtained without a prescription.
This medicine contains paracetamol. Other medicines contain paracetamol.
Check that you are not taking any other medicines containing paracetamol, including medicines obtained without a prescription.
Do not combine them, so as not to exceed the recommended daily dose.
Consult your doctor or pharmacist:
- if you are taking drugs that are potentially toxic to the liver. Paracetamol toxicity may be increased.
- if you or your child have been prescribed a uric acid or blood sugar test, as paracetamol may alter the results.
- if you are taking a drug that slows clotting (oral anticoagulants). At high doses, DAFALGAN 500 mg, capsule may increase the action of your anticoagulant. If necessary, your doctor will adjust the dosage of your anticoagulant.
- if you are taking flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called high anion gap metabolic acidosis), which requires emergency treatment (see section 2).
Dafalgan 500 mg, capsule with alcohol
Consumption of alcoholic beverages during treatment is not recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you might be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking any medication.
Pregnancy and breast-feeding
If required, this drug may be used during pregnancy and lactation.
You should use the lowest possible dose to relieve pain and/or fever, and take it for the shortest possible time. Contact your doctor if the pain and/or fever do not subside, or if you need to take the medication more frequently.
Fertility
It is possible that paracetamol may impair fertility in women, reversible on discontinuation of treatment.
Driving and use of machinery
Paracetamol has no or negligible effect on the ability to drive vehicles and use machines.
Dafalgan 500 mg, capsule contains zorubin (E122) and sodium.
This medicine contains an azoic coloring agent (E122 azorubin) and may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE Dafalgan 500 mg, capsule?
Always take this medicine exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
For adults and children weighing 27 kg or more (approx. 8 years).
Use the lowest effective dose for the shortest possible duration. Use the 1000 mg dose for pain and/or fever not relieved by a 500 mg dose of paracetamol.
Dosage depends on weight. Ages are given for information only. If you don't know your child's weight, you should weigh him/her in order to give him/her the paracetamol presentation with the most appropriate dosage. The recommended daily dose of paracetamol should be divided into several doses, without exceeding the maximum doses shown in the table below.
|
Weight (approximate age) |
Maximum dose per administration |
Interval between two doses |
Maximum dose per day |
|
Child 27 kg - 40 kg (approx. 8 to 12 years) |
500 mg |
6 hours minimum |
2000 mg per day or 2 g |
|
Children 41 kg - 49 kg |
500 mg |
4 hours minimum |
3000 mg per day or 3 g |
|
Adults and children over 50 kg (about 15 years old) |
500 mg to 1000 mg or 500 mg to 1 g |
4 hours minimum |
3000 mg per day, i.e. 3 g |
Caution: To avoid the risk of overdosing, check that paracetamol is not included in the composition of other medicines, including over-the-counter products. Respect the maximum recommended dose or the dose prescribed by your doctor: a higher dose will not relieve your pain any more, but may have serious consequences for your liver.
Adults weighing less than 50 kg, chronic malnutrition, dehydration, the elderly:
ask your doctor or pharmacist for advice.
Hepatic insufficiency, chronic alcoholism and Gilbert's syndrome: never exceed 2000 mg (2 g) paracetamol per day.
Renal insufficiency: Dosage must be adapted to the degree of renal insufficiency. Consult your doctor before taking this drug.
If you feel that the effect of this medicine is too strong or too weak, do not exceed the dose, but ask your doctor or pharmacist for advice.
How to take it
Take by mouth.
Capsules should be swallowed whole with a glass of water.
Duration of treatment
Frequent or prolonged use without medical supervision is not recommended.
Except on medical advice, treatment duration is limited to 5 days in case of pain and 3 days in case of fever.
If symptoms persist beyond this period, or worsen, or if new symptoms appear, stop treatment and consult your doctor immediately.
If you have taken more Dafalgan 500 mg, capsule than you should have
Stop treatment and consult immediately your doctor or seek medical attention immediately.
Overdose can be fatal.
Overdosage can cause liver damage, brain inflammation, coma and even death, particularly in high-risk populations such as young children, the elderly and in certain situations (liver or kidney disease, chronic alcoholism, chronic malnutrition, fasting, weight loss).and in certain situations (liver or kidney disease, chronic alcoholism, chronic malnutrition, fasting, recent weight loss, Gilbert's syndrome and in patients treated concomitantly with certain drugs). Cases of inflammation of the pancreas (causing severe abdominal and back pain), increased damylase levels in the blood, kidney failure and a simultaneous reduction in red blood cells, white blood cells and platelets have also been reported.
Within the first 24 hours, the main symptoms of toxicity are nausea, vomiting, paleness, malaise, sweating, loss of appetite and abdominal pain.
If you forget to take Dafalgan 500 mg, capsule
Do not take a double dose to make up for the single dose you forgot to take.
If you stop taking Dafalgan 500 mg, capsule
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not always occur in everyone.
Rare adverse reactions Rare side effects: may affect up to 1 in 1,000 people.
- reddening of the skin, rash, urticaria. Stop taking paracetamol immediately, tell your doctor and never take paracetamol again.
- blood spots on the skin (purpura). Stop treatment immediately and inform your doctor. Treatment may be reintroduced only on the advice of your doctor.
- diarrhea, abdominal pain.
Very rare side effects may affect up to 1 in 10,000 people.
- severe skin reactions. Stop taking paracetamol immediately, tell your doctor and never take paracetamol again.
- biological changes requiring blood tests: abnormally low levels of certain white blood cells (leukopenia, neutropenia) or of certain blood cells such as platelets (thrombocytopenia), which may lead to nose or gum bleeding. In this case, consult a doctor.
Undesirable effects of undetermined frequency Frequency cannot be estimated from available data.
- skin rash or redness, or allergic reaction manifested by sudden swelling of the face and neck which may cause difficulty in breathing (angioedema), or by sudden malaise with a drop in blood pressure (anaphylactic shock). Stop taking paracetamol immediately, tell your doctor and never take paracetamol again.
- abnormal liver function.
- rash in the form of red, rounded patches with itching and a burning sensation, leaving coloured spots which may appear in the same places if the drug is taken again (erythema pigmentosa difficulty in breathing (bronchospasm), particularly if you have previously experienced breathing difficulties with other medications such as non-steroidal anti-inflammatory drugs or acetylsalicylic acid. In this case, consult a physician.
- a serious condition which can cause the blood to become more acidic (known as metabolic acidosis), in patients with serious illnesses taking paracetamol (see section 2).
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW DO I USE Dafalgan 500 mg, capsule?
Keep out of sight and reach of children.
Store at a temperature not exceeding 30°C.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. PACKAGING CONTENTS AND OTHER INFORMATION
What DAFALGAN 500 mg capsule contains
- The active substance is :
Paracetamol................................................................................................................... 500 mg
For one capsule.
- The other components are :
Magnesium stearate.
Capsule n°0 composition: Gelatin and azorubin (E122)*. *See section 2.
What Dafalgan 500 mg capsule is and what it contains
This medicine comes in the form of a red and white capsule. Boxes of 16 or 100.
Marketing authorization holder
UPSA SAS
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Marketing authorization holder
UPSA SAS
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Manufacturer
UPSA SAS
304, avenue du docteur jean bru
47000 agen
Or
UPSA SAS
979, AVENUE DES PYRENEES
47520 LE PASSAGE
Drug names in member states of the European Economic Area
Not applicable.
This leaflet was last revised on :
[to be completed later by the holder].
{month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.
Health Education Council:
WHAT TO DO IN CASE OF FEVER :
Normal body temperature varies from person to person, ranging from 36.5°C to 37.5°C. A rise in temperature above 38°C can be considered a fever, but it is not advisable to treat fever with medication below 38.5°C.
This medicine is reserved for adults and children weighing 27 kg (approx. 8 years) and over.
If fever troubles are too troublesome, you can take this medication, which contains paracetamol, in the dosage indicated.
To avoid any risk of dehydration, remember to drink frequently.
With this medication, fever should fall rapidly. Nevertheless :
- if other unusual signs appear,
- if fever persists for more than 3 days or worsens,
- if headaches become severe, or if vomiting occurs,
CONSULT YOUR DOCTOR IMMEDIATELY.
WHAT TO DO IN CASE OF PAIN :
The intensity of pain perception and the ability to resist it vary from person to person.
- If there is no improvement after 5 days of treatment,
- if the pain is violent, unexpected and sudden (in particular, a strong pain in the chest) and/or recurs regularly,
- if it is accompanied by other signs such as general malaise, fever, unusual swelling of the painful area or reduced strength in a limb,
- if it wakes you up at night,
CONSULT YOUR DOCTOR IMMEDIATELY.
Fever is characterized by a marked increase in body temperature. It manifests itself in all warm-blooded living beings and in humans, this rise can go beyond 40 ° C. As the normal temperature of the human body oscillates between 36.5 ° C and 37.5 ° C, it is considered to be in the presence of a fever from 38 °…
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