Patient leaflet - Paracetamol, Phenylephrine Hydrochloride and Ascorbic Acid 1000 mg/10 mg/40 mg
1. What Paracetamol, Phenylephrine hydrochloride and Ascorbic
Acid does
Paracetamol, Phenylephrine hydrochloride and Ascorbic acid 1000mg/10mg/40mg Powder for Oral Solution is used for the short term relief of the symptoms of flu, colds and chills. These symptoms include headache, shivers, aches and pains, blocked nose and painful sinuses, catarrh and sore throat. This medicine contains three active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Phenylephrine hydrochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily. Ascorbic acid (vitamin C) is a common ingredient of cold and flu products. It is included to help replace vitamin C which may be lost in the initial stages of colds and flu.
2. Check before you take Paracetamol, Phenylephrine hydrochloride and Ascorbic Acid
<Cross> Do not take Paracetamol, Phenylephrine hydrochloride and Ascorbic acid:
- if you have ever had an allergic reaction to paracetamol, phenylephrine hydrochloride, ascorbic acid or any of the other ingredients (listed in Section 6)
- if you have kidney or liver problems, overactive thyroid, diabetes, high blood pressure or heart disease
- if you have an enlarged prostate
- if you have phaeochromocytoma or glaucoma
- if you are taking tricyclic antidepressants (e.g. imipramine or amitriptyline) or if you are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) prescribed for depression
- if you are taking beta blockers.
Do not take anything else containing paracetamol while taking this medicine. Do not take with any other flu, cold or decongestant product.
<exclamation mark> Take special care with Paracetamol, Phenylephrine hydrochloride and Ascorbic acid
Contains paracetamol. Taking too much paracetamol can cause serious harm to your liver.
This product may cause dizziness. If affected, do not drive or operate machinery.
- If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.
- This medicine contains 120 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 5% of the recommended maximum daily dietary intake of sodium for an adult.
<exclamation mark> Ask your doctor before you take this medicine:
- if you have a blood vessel disease such as Raynaud’s Phenomenon
- if you have heart or circulation disease
- if you have diabetes mellitus. Each dose contains 4 g of sucrose.
- if you are on a controlled-sodium diet. Each dose contains 0.12 g of sodium.
- if you have liver or kidney problems.
- if you have a severe infection as this 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
Contact a doctor immediately if you get a combination of these symptoms.
During treatment with this medicine, tell your doctor straight away if you have:
Severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).
<exclamation mark> If you are taking other medicines
Talk to your doctor or pharmacist before taking Paracetamol, Phenylephrine HCI, Ascorbic Acid 1000mg/10mg/40mg Powder for Oral Solution if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or ergotamine or methylsergide (for migraine) or colestyramine (to lower blood cholesterol) or drugs to lower blood pressure; appetite suppressants or stimulants; drugs to treat depression such as tricyclic antidepressants (e.g. amitriptyline) or heart disease (e.g. digoxin) or if you take blood thinning drugs (anticoagulants e.g. warfarin).
Please inform your doctor or pharmacist if you are taking:
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
<exclamation mark> Pregnancy and breast feeding
Do not take Paracetamol, Phenylephrine hydrochloride and Ascorbic acid if you are pregnant or breast feeding unless advised by a doctor.
3. How to take Paracetamol, Phenylephrine hydrochloride and Ascorbic acid
<Tick> Adults and children aged 16 years and over:
Empty the contents of one sachet into a mug. Half fill with very hot water. Stir well.
Add cold water as necessary and sugar if desired.
Always use the lowest effective dose to relieve your symptoms.
Take one sachet every 4 -6 hours as needed.
<Exclamatio n mark>
- Do not take more frequently than every 4 hours.
- Do not take more than 4 sachets in 24 hours.
- Do not take more than the recommended dose.
- Do not take for more than 7 days without asking your doctor.
- Do not give to children under 16 years.
If you take too many sachets
Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
If symptoms persist, see your doctor.
4. Possible side effects
Like all medicines, Paracetamol, Phenylephrine hydrochloride and Ascorbic acid can have side effects, but not everybody gets them.
Stop taking this medicine and tell your doctor immediately if you experience:
- Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath.
- Skin rash or peeling, or mouth ulcers. Very rare cases of serious skin reactions have been reported.
- Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen or aspirin.
- Unexplained bruising or bleeding.
- Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
- Visual disturbances. This is rare but is more likely in those with glaucoma.
- Unusually fast pulse rate or a sensation of an unusually fast or irregular heartbeat.
- Reoccurring fevers or infections.
Difficulty passing water. This is more likely to occur in men with an enlarged prostate gland. These reactions are rare.
The following side effects may occur. Tell your doctor if you get them.
- Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, anxiety, diarrhoea or sickness.
- A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2) (Frequency “Not known” (frequency cannot be estimated from the available data).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Paracetamol, Phenylephrine hydrochloride and Ascorbic acid
Keep out of the sight and reach of children.
Do not use this medicine after the ‘EXP’ date shown on the pack.
Do not store above 25ºC.
6. Further information
Active ingredients Each dose contains Paracetamol 1000 mg, Phenylephrine Hydrochloride 10 mg and Ascorbic acid (Vitamin C) 40mg.
Other ingredients Sucrose, sodium citrate, citric acid anhydrous, maize starch, sodium cyclamate, saccharin sodium, colloidal anhydrous silica, lemon flavour, natural curcumin (E 100).
Packs of this medicine contain 5 or 10 sachets of powder.
Not all pack sizes may be marketed.
The marketing authorisation holder is Thornton & Ross Ltd, Linthwaite, Huddersfield, HD7 5QH, UK and all enquiries should be sent to this address.
The manufacturer is SmithKline Beecham SA, Ctra de Ajalvir, Km 2500, 28806 Alcala de Henares, Madrid, Spain.
This leaflet was last revised in May 2025.
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