SCHEDULING STATUS
S2
Product Name
BENYLIN® FOUR FLU LIQUID
Active Ingredients
Diphenhydramine hydrochloride / pseudoephedrine hydrochloride / paracetamol
Each 20 mL of liquid contains:
| Active substance | Quantity per 20 mL |
|---|---|
| Diphenhydramine hydrochloride | 25,0 mg |
| Paracetamol | 1 000,0 mg |
| Pseudoephedrine hydrochloride | 45,0 mg |
Read Before Using BENYLIN® FOUR FLU LIQUID
BENYLIN® FOUR FLU LIQUID is available without a doctor’s prescription for you or your child to treat a mild illness.
Nevertheless, BENYLIN® FOUR FLU LIQUID should be used carefully to get the best results.
Keep this information because it may be needed again. Do not share BENYLIN® FOUR FLU LIQUID with any other person. Ask a healthcare provider or pharmacist if more information or advice is needed.
A doctor should be consulted if symptoms worsen or do not improve after 10 days.
What Is in This Article
- What BENYLIN® FOUR FLU LIQUID is and what it is used for
- What you need to know before you use BENYLIN® FOUR FLU LIQUID
- How to use BENYLIN® FOUR FLU LIQUID
- Possible side effects
- How to store BENYLIN® FOUR FLU LIQUID
- Contents of the pack and other information
1. What BENYLIN® FOUR FLU LIQUID Is and What It Is Used For
BENYLIN® FOUR FLU LIQUID contains:
| Ingredient type | Active ingredient |
|---|---|
| Analgesic and antipyretic | Paracetamol |
| Antihistamine | Diphenhydramine |
| Decongestant | Pseudoephedrine |
BENYLIN® FOUR FLU LIQUID belongs to a class of medicines used to relieve symptoms of colds and flu.
BENYLIN® FOUR FLU LIQUID is used to help relieve:
| Symptoms relieved |
|---|
| Cough congestion |
| Fever |
| Body pains |
| Stuffy nose |
Paracetamol helps relieve pain and fever. Diphenhydramine helps relieve coughing. Pseudoephedrine helps unblock stuffy noses.
2. What You Need to Know Before You Use BENYLIN® FOUR FLU LIQUID
Do Not Use or Give BENYLIN® FOUR FLU LIQUID
Do not use or give BENYLIN® FOUR FLU LIQUID if any of the following apply:
| Do not use or give BENYLIN® FOUR FLU LIQUID if | Details |
|---|---|
| You or your child are allergic to diphenhydramine hydrochloride | This includes allergy to the active substance |
| You or your child are allergic to paracetamol | This includes allergy to the active substance |
| You or your child are allergic to pseudoephedrine hydrochloride | This includes allergy to the active substance |
| You or your child are allergic to any other ingredient | See the contents section |
| You or your child suffer from high blood pressure | BENYLIN® FOUR FLU LIQUID may not be suitable |
| You or your child suffer from heart disease | Medical advice is required |
| You or your child suffer from angina | Angina is chest pain |
| You or your child suffer from hyperexcitability | BENYLIN® FOUR FLU LIQUID may not be suitable |
| You or your child have an over-active thyroid | Medical advice is required |
| You or your child have phaeochromocytoma | This is a rare tumour that affects heart rate and blood pressure |
| You or your child suffer from glaucoma | This means pressure in the eye |
| You or your child suffer from severe liver disease | BENYLIN® FOUR FLU LIQUID should not be used |
| You or your child are taking MAOIs | This includes monoamine oxidase inhibitors and linezolid |
| You or your child stopped MAOI treatment within the last 14 days | BENYLIN® FOUR FLU LIQUID should not be used |
| You or your child are going to have surgery using cyclopropane, halothane or other halogenated anaesthetics | BENYLIN® FOUR FLU LIQUID should not be used |
| The child is under 12 years of age | BENYLIN® FOUR FLU LIQUID should not be used in children under 12 years |
Warnings and Precautions
Take Special Care With BENYLIN® FOUR FLU LIQUID
Contact a doctor before using BENYLIN® FOUR FLU LIQUID if any of the following apply:
| Situation requiring special care |
|---|
| You or your child have heart problems |
| You or your child have kidney problems |
| You or your child have liver problems, including alcoholic liver disease |
| You or your child have thyroid problems |
| You or your child have diabetes mellitus |
| You or your child have difficulty passing water, also called urinary retention |
| You or your child have prostate disease |
| You or your child regularly consume a large amount of alcohol |
| You or your child suffer from a persistent cough such as occurs with asthma |
| You or your child produce a lot of mucus or phlegm |
| You or your child have emphysema |
| You or your child have asthma |
| You or your child have bronchitis |
| You or your child are taking medicines containing paracetamol, pseudoephedrine or diphenhydramine |
| You or your child are taking medicines prescribed by a doctor, especially antidepressants or atropine |
Do not take more than the recommended dose. BENYLIN® FOUR FLU LIQUID may cause severe damage to the liver or kidneys.
Do not use continuously for more than 10 days without consulting a doctor.
BENYLIN® FOUR FLU LIQUID may cause drowsiness or difficulty in concentration. Make sure you or your child are not affected before doing anything that requires alertness.
The chances of drowsiness and dry mouth may be increased if BENYLIN® FOUR FLU LIQUID is taken with medicines that make you drowsy or cause dry mouth.
Do not use alcohol while taking BENYLIN® FOUR FLU LIQUID.
Stop Using BENYLIN® FOUR FLU LIQUID If the Following Happens
Stop using BENYLIN® FOUR FLU LIQUID and speak to a doctor if any of the following occur:
| Stop using if |
|---|
| Restlessness |
| Hallucinations |
| Sleep disturbances |
| Sudden skin rash |
| Small pustules, with or without fever |
| Pain in the stomach area |
| Blood in the stool |
| Nausea |
| Vomiting |
| Symptoms that persist or get worse |
| New symptoms |
Sudden stomach pain, blood in the stool, nausea or vomiting may be signs of ischaemic colitis.
Children and Adolescents
Do not use BENYLIN® FOUR FLU LIQUID in children under 12 years of age.
Other Medicines and BENYLIN® FOUR FLU LIQUID
Always tell your healthcare professional if you are taking or giving your child any other medicine. This includes complementary or traditional medicines.
Talk to your doctor or pharmacist before taking BENYLIN® FOUR FLU LIQUID if you or your child are taking:
| Medicine or medicine group | Use or concern |
|---|---|
| Monoamine oxidase inhibitors | Used to treat mood disorders |
| Antidepressants | Used to treat mood disorders |
| Hypnotics | Sleeping tablets, including barbiturates |
| Sedatives | May increase drowsiness |
| Barbiturates | May increase drowsiness |
| Neuroleptic medicines | May increase central nervous system effects |
| Tranquillisers | Used to relax muscles or decrease anxiety |
| Antipsychotics | Used to treat mood disorders |
| Decongestants | May duplicate effects |
| Appetite suppressants | May duplicate stimulant effects |
| Stimulants or sympathomimetic medicines | May increase side effects |
| Medicines used to treat high blood pressure | Interaction may occur |
| Atropine | Used to treat eye conditions or sometimes bowel disorders |
| Metoclopramide or domperidone | Used to treat nausea and vomiting |
| Cholestyramine | Used to treat high cholesterol |
| Anticoagulants such as warfarin | Medicines that thin the blood |
| Antibacterial medicines, including linezolid | Used to treat bacterial infections |
| Cardiac glycosides or quinidine | Used to treat heart rhythm disorders |
| Probenecid | Used to treat gout |
Do not take BENYLIN® FOUR FLU LIQUID with other medicines containing paracetamol, diphenhydramine, pseudoephedrine or similar acting components.
BENYLIN® FOUR FLU LIQUID should not be taken with alcohol.
BENYLIN® FOUR FLU LIQUID With Food, Drink and Alcohol
Do not take BENYLIN® FOUR FLU LIQUID with alcohol.
Pregnancy, Breastfeeding and Fertility
Safety in pregnancy and during breastfeeding has not been established.
If pregnant, breastfeeding, possibly pregnant or planning to have a baby, consult a doctor, pharmacist or other healthcare professional before taking BENYLIN® FOUR FLU LIQUID.
Driving and Using Machines
BENYLIN® FOUR FLU LIQUID can make some people feel:
| Possible effect |
|---|
| Drowsy |
| Dizzy |
| Blurred vision |
Make sure you or your child are not affected when alertness is needed.
Do not drive, operate machinery or climb dangerous heights if affected, because weakened decision-making could lead to accidents.
BENYLIN® FOUR FLU LIQUID Contains Sodium Benzoate
Sodium benzoate may increase jaundice, which is yellowing of the skin and eyes, in newborn babies up to 4 weeks old.
3. How to Use BENYLIN® FOUR FLU LIQUID
DO NOT TAKE MORE THAN THE RECOMMENDED DOSE.
Do not share medicines prescribed for you or your child with any other person or child.
BENYLIN® FOUR FLU LIQUID is for oral use only.
Shake the bottle before use.
The Usual Dose Is
| Patient group | Dose |
|---|---|
| Adults, the elderly and children over 12 years | 20 mL, equal to four 5 mL medicine measurements, four times daily as required |
| Children under 12 years | Not recommended |
Timing between doses should not be less than 4 hours.
Food does not affect the amount of paracetamol absorbed into the body. High fat meals will delay the absorption of pseudoephedrine.
Maximum daily dose: Do not exceed four doses in 24 hours.
If the effect of BENYLIN® FOUR FLU LIQUID seems too strong or too weak, tell your doctor or pharmacist.
If You Take More BENYLIN® FOUR FLU LIQUID Than You Should
In the event of overdose, consult a doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.
Take along any remaining medicine and the carton so the hospital can identify what was taken or given.
Immediate medical advice should be sought in the event of an overdose, even if you or your child feel well, because of the risk of delayed serious liver damage.
If You Forget to Use BENYLIN® FOUR FLU LIQUID
BENYLIN® FOUR FLU LIQUID should only be used or given as required, following the recommended dose.
If a dose is forgotten, take it or give it as soon as remembered unless it is time for the next dose.
Do not take or give two doses at the same time.
4. Possible Side Effects
BENYLIN® FOUR FLU LIQUID can have side effects.
Not all side effects reported for BENYLIN® FOUR FLU LIQUID are included here. If your or your child’s general health worsens, or if any untoward effects occur while using BENYLIN® FOUR FLU LIQUID, consult a doctor, pharmacist or other healthcare professional.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| Very serious allergic reactions | Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty swallowing or breathing | Stop using or giving BENYLIN® FOUR FLU LIQUID and seek urgent medical attention immediately |
| Very serious allergic reactions | Rash or itching | Stop using or giving BENYLIN® FOUR FLU LIQUID and seek urgent medical attention immediately |
| Very serious allergic reactions | Fainting | Stop using or giving BENYLIN® FOUR FLU LIQUID and seek urgent medical attention immediately |
| Serious less frequent side effects | Blood disorders, including becoming unusually tired, unexpected bruising or bleeding, and getting more infections such as colds than usual | Tell your doctor immediately or go to the nearest casualty department |
| Serious less frequent side effects | Increased heartbeat, palpitations, or irregular, fast or slow heart rate | Tell your doctor immediately or go to the nearest casualty department |
| Serious less frequent side effects | Kidney problems leading to less urine than normal, difficulty passing urine, or painful urination, especially in patients with an enlarged prostate | Tell your doctor immediately or go to the nearest casualty department |
| Serious less frequent side effects | Shortness of breath | Tell your doctor immediately or go to the nearest casualty department |
| Serious side effects, frequency not known | Heart attack, with chest pain or tightness in the chest, pain radiating into the arms or back, shortness of breath, tiredness, light-headedness or dizziness | Seek urgent medical attention |
| Serious side effects, frequency not known | Very serious skin disorders such as acute generalised exanthematous pustulosis, including painful red or purplish rash with fluid-filled blisters | Seek urgent medical attention |
| Serious side effects, frequency not known | Allergic reactions to other medicines containing sympathomimetic medicines, such as stimulants, appetite suppressants, and medicines used for congestion and asthma | Seek medical advice immediately |
| Serious side effects, frequency not known | Convulsions, which may precipitate fits if you or your child is epileptic | Seek urgent medical attention |
| Serious side effects, frequency not known | Tightness of the chest | Seek urgent medical attention |
| Serious side effects, frequency not known | Stroke, characterised by sudden numbness or weakness of the face, arm or leg, especially on one side of the body, or slurred speech | Seek urgent medical attention |
| Serious side effects, frequency not known | Abnormal blood test results for liver function tests, yellowing of the skin and eyes, dark urine, and tiredness that may be symptoms of liver problems | Tell your doctor immediately |
| Serious side effects, frequency not known | Ischaemic colitis, with pain in the stomach area, blood in the stool, nausea or vomiting | Tell your doctor immediately |
| Frequent side effects | Drowsiness to deep sleep, including difficulty performing tasks that require attention and concentration | Tell your doctor if troublesome |
| Frequent side effects | Loss of energy, dizziness or lack of coordination | Tell your doctor if troublesome |
| Less frequent side effects | High blood pressure | Tell your doctor |
| Less frequent side effects | Restlessness, sleep disturbances, irritability, anxiety, tremor, confusion or mood changes | Tell your doctor |
| Less frequent side effects | Extrapyramidal symptoms, characterised by continuous spasms and muscle contractions | Tell your doctor |
| Less frequent side effects | Low blood pressure, especially in elderly patients, including dizziness | Tell your doctor |
| Less frequent side effects | Nausea, sickness, vomiting, diarrhoea, constipation, reduced appetite, increased appetite, pain in the upper stomach area or increased saliva | Tell your doctor |
| Less frequent side effects | Photosensitivity of the skin, changes in skin test results, or increased sweating | Tell your doctor |
| Less frequent side effects | Pancreatitis, with stomach pain radiating to the back, fever, nausea or vomiting | Tell your doctor immediately |
| Less frequent side effects | Low potassium levels, with muscle cramps or changes in heartbeat | Tell your doctor |
| Less frequent side effects | Headache | Tell your doctor if troublesome |
| Less frequent side effects | Flushing or weakness | Tell your doctor |
| Frequency not known | Hallucinations, excitability or psychosis, meaning difficulty distinguishing reality from imagination | Tell your doctor |
| Frequency not known | Euphoria, stimulation or depression | Tell your doctor |
| Frequency not known | Paraesthesia, including tingling or numbness of the hands and feet, agitation or inability to sit still | Tell your doctor |
| Frequency not known | Blurred vision or tinnitus, meaning ringing in the ears | Tell your doctor |
| Frequency not known | Dry mouth or thickened mucus | Tell your doctor |
| Frequency not known | Stomach pain or indigestion | Tell your doctor |
| Frequency not known | Muscle weakness | Tell your doctor |
| Frequency not known | Changes in metabolism, including blood sugar levels | Tell your doctor |
| Frequency not known | Jittery feeling | Tell your doctor |
| Side effects not listed | Any side effect not mentioned or any unexpected health change | Inform your doctor or pharmacist |
Reporting of Side Effects
If side effects occur, talk to your doctor or pharmacist.
Reporting side effects helps provide more information on the safety of BENYLIN® FOUR FLU LIQUID.
For further product-related information, the Johnson & Johnson call centre may be contacted on 0860 410032.
5. How to Store BENYLIN® FOUR FLU LIQUID
Store at or below 25 °C.
Keep the medicine in the original container.
Protect from light.
Store all medicines out of reach of children.
Keep the bottle tightly closed.
Do not use after the expiry date stated on the labelling.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems, including toilets.
6. Contents of the Pack and Other Information
What BENYLIN® FOUR FLU LIQUID Contains
The active substances are:
| Active substance | Quantity per 20 mL |
|---|---|
| Diphenhydramine hydrochloride | 25,0 mg |
| Paracetamol | 1 000,0 mg |
| Pseudoephedrine hydrochloride | 45,0 mg |
The liquid contains:
| Ingredient | Quantity |
|---|---|
| Sodium benzoate | 0,2 % m/v |
| Alcohol | 9,9 % v/v |
The other ingredients are:
| Other ingredients |
|---|
| Citric acid |
| Colourants: D & C Yellow No. 10, patent blue V and Ponceau 4R |
| Denatured alcohol menthol |
| Flavourants: milk cream, eucalyptol, honey, lemon and menthol |
| Glycerol |
| Polyethylene glycol |
| Propylene glycol |
| Purified water |
| Sodium benzoate |
| Sodium carboxymethylcellulose |
| Sodium citrate |
| Sodium saccharin |
What BENYLIN® FOUR FLU LIQUID Looks Like and Contents of the Pack
BENYLIN® FOUR FLU LIQUID is a clear, orange liquid with a characteristic honey and lemon odour and taste.
It is supplied in a round, amber glass bottle with a plastic measuring cup.
| Pack size |
|---|
| 100 mL |
| 200 mL |
Holder of Certificate of Registration
Johnson & Johnson (Pty) Ltd.
241 Main Road
Retreat
7945
South Africa
This Leaflet Was Last Revised In
| Item | Date |
|---|---|
| Date of registration | 13 October 2000 |
| Date of revision | 30 May 2024 |
Registration Number
33/5.8/0345
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist or other healthcare professional. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
