Formulaexpec 13.33 mg/ml syrup flavored honey
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
FormulaExpec 13.33 mg/ml honey-flavoured syrup
Guaifenesin
Read the entire leaflet carefully before you start taking this medicine,
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens, if symptoms are accompanied by high fever, skin rash, or persistent headache, or if there is no improvement after 7 days of treatment.
Contents of this leaflet:
- What FormulaExpec is and what it is used for
- What you need to know before taking FormulaExpec
- How to take FormulaExpec
- Possible adverse effects
- How to store FormulaExpec
- Contents of the pack and other information
1. What FormulaExpec is and what it is used for
Guaifenesin, the active substance in this medicine, belongs to a group of medicines called expectorants.
This medicine is indicated for the relief of productive cough by reducing phlegm (mucus) and facilitating its expulsion in adults and children aged 6 years and older.
You should consult a doctor if symptoms worsen or do not improve after 7 days of treatment.
2. What you need to know before taking FormulaExpec
Do not take FormulaExpec:
- if you are allergic (hypersensitive) to guaifenesin or any of the other ingredients of this medicine (listed in section 6).
- if you have porphyria, a metabolic disorder.
- children under 6 years of age must not take this medicine.
Warnings and precautions
Consult your doctor or pharmacist or nurse before taking this medicine if:
- you have had a cough for more than 7 days, or if your cough is recurrent or accompanied by fever, rash, or persistent headache.
- you have chronic or persistent cough, such as that associated with asthma, smoking, chronic bronchitis, or emphysema (serious lung disease).
- you have a cough with a large amount of mucus (phlegm).
- you have severe liver or kidney problems.
- you are diabetic or have difficulty digesting certain sugars.
Interference with diagnostic tests
If you are due to have any diagnostic tests (including blood or urine tests), it is important to inform your doctor or nurse that you are taking or have recently taken this medicine, as it may alter some test results.
Inform your doctor and stop taking this medicine 48 hours before undergoing urine tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA), which are specific tests for tumors.
Children and adolescents
Children under 6 years of age must not take this medicine, as it is contraindicated.
Taking FormulaExpec with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
- It is not recommended to take this medicine together with other cough-suppressant medicines (antitussives or cough suppressants).
Taking FormulaExpec with food, drinks, and alcohol
You may take this medicine with or without food.
Do not drink alcohol while taking this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy unless directed by a doctor.
Do not take this medicine while breastfeeding unless directed by a doctor.
Driving and using machines
FormulaExpec is not expected to affect your ability to drive or operate machinery.
However, if you experience dizziness, do not drive or operate machinery.
FormulaExpec contains sucrose, ethanol, sodium, propylene glycol, and sodium benzoate:
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine. Patients with diabetes mellitus should be aware that this medicine contains 5.55 g of sucrose per dose.
This medicine contains 5.256% by volume of ethanol (alcohol), corresponding to 597 mg per 15 ml. The amount in each 15 ml dose of this medicine is equivalent to less than 12 ml of beer and 5 ml of wine. The small amount of alcohol in this medicine will have no noticeable effect.
This medicine contains 27.9 mg of sodium (a main component of cooking/table salt) in each dose (15 ml). This corresponds to 1.40% of the maximum daily sodium intake recommended for an adult.
This medicine contains 1,650 mg of propylene glycol in each dose, equivalent to 1,650 mg per 15 ml. If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine. If you have hepatic or renal insufficiency, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.
This medicine contains 15 mg of sodium benzoate per dose equivalent to 15 ml.
3. How to take FormulaExpec
Follow exactly the instructions for use of this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.
Recommended dose:
Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.
Adults and adolescents aged 12 years and older: Take 15 ml three times a day, measured with the dosing cup provided in the package. If necessary, the dose may be repeated every 6 hours. Do not exceed 6 doses in 24 hours. The maximum amount to be taken in 24 hours is 90 ml, divided into several doses.
Use in children and adolescents
Children between 6 and 11 years of age: Take 10 ml three times a day, measured with the dosing cup provided in the package. If necessary, the dose may be repeated every 6 hours. Do not exceed 5 doses in 24 hours. The maximum amount to be taken in 24 hours is 45 ml, divided into several doses.
Children under 6 years of age: Do not administer this medicine to children under 6 years of age.
How to take this medicine
Shake the bottle well before taking this medicine.
FormulaExpec is taken orally.
Measure the required amount using the dosing cup.
Do not exceed the recommended dose.
Consult a doctor if your condition worsens, if symptoms are accompanied by high fever, skin rash, or persistent headache, or if there is no improvement after 7 days of treatment.
If you take more FormulaExpec than you should
If you take more FormulaExpec than recommended, you may experience stomach discomfort, nausea, and drowsiness.
In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take FormulaExpec
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
Guaifenesin rarely causes side effects.
The following may occur: nausea, vomiting, and diarrhoea; stomach ache, headache, and dizziness.
If you experience any of the following adverse effects, stop taking this medicine and consult your doctor immediately:
- Allergic reactions including skin rash (which may be severe, with blistering, skin erosion, and peeling), itching, and redness. Difficulty breathing, swelling of the face, lips, tongue, or throat.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of FormulaExpec
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging
after “EXP”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers
and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure,
ask your pharmacist how to dispose of containers and unused medicines.
This helps protect the environment.
6. Contents of the pack and other information
Composition of FormulaExpec
- The active substance is guaifenesin 13.33 mg/ml.
- The other components are: sucrose, propylene glycol, ethanol, sodium citrate,
carboxymethylcellulose sodium, citric acid, macrogol stearate, ginger honey flavour, verbena flavour,
sodium benzoate (E-211), polyethylene oxide, sodium saccharin, menthol,
water.
(See also “FormulaExpec contains sucrose, ethanol, sodium, propylene glycol and sodium benzoate” in section 2).
Appearance of the medicine and contents of the pack
FormulaExpec is available in amber glass bottles with a child-resistant safety cap. The medicine comes in 120 ml and 180 ml bottles containing a pale yellow liquid, together with a graduated polypropylene dosing cup (5 ml, 10 ml, 15 ml and 30 ml).
Only certain pack sizes may be marketed.
Marketing Authorization Holder:
Laboratorios Vicks, S.L.U
Avda. de Bruselas, 24.
28108, Alcobendas. Madrid
Spain
Local Representative:
Procter & Gamble España, S.A.
Avenida de Bruselas, 24,
28108 Alcobendas. Madrid.
Spain
Manufacturer:
Procter & Gamble Manufacturing GmbH
Procter & Gamble Strasse 1,
64521, Gross Gerau
Germany
This leaflet was approved in: October 2025
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.gob.es/