Israel - English - Ministry of Health
PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed without a doctor’s
Active ingredients: each 5 ml of syrup contains:
Potassium guaiacolsulphonate 120 mg
Sodium benzoate 20 mg
Ephedrine HCl 6 mg
Dextromethorphan hydrobromide 5 mg
For inactive ingredients in the preparation - see
section 6: “Further Information”.
Read this leaflet carefully in its entirety before
using the medicine. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine is not intended for children and
infants under 1 year of age.
You must use/take it correctly. Consult the
pharmacist if you need more information. Refer
to a doctor if the symptoms get worse or if they
do not improve after 7 days.
1. WHAT IS THE MEDICINE INTENDED
This medicine is intended to relieve cough.
Ephedrine is a sympathomimetic.
Dextromethorphan hydrobromide is a cough
2. BEFORE USING THE MEDICINE
Do not use the medicine:
if you are sensitive )allergic( to the active
ingredient or to any of the other ingredients
contained in the medicine.
during an asthma attack or respiratory
if you are pregnant or breastfeeding.
if you are currently taking a monoamine
oxidase inhibitor )for depression( or you have
stopped taking it within the last 14 days.
if you are taking a SSRI )selective serotonin
reuptake inhibitor, such as fluoxetine(.
if you are suffering from problems with liver
in infants under 1 year of age.
Special warnings regarding use of the
Do not use this medicine often or for a
prolonged period without consulting a doctor.
If you are sensitive to any food or medicine,
you must inform the doctor before taking the
Do not use this medicine without consulting
a doctor before commencing treatment:
if you are suffering, or have suffered in the
past, from impaired function of: the respiratory
system )such as asthma(, the heart and/or
blood vessels, the eyes )such as glaucoma(,
the kidney/urinary tract, the thyroid gland, the
if you are suffering or have suffered in the past,
from allergy )especially allergy to medicines(,
in case of prolonged cough caused by smoking
or any problem involving the respiratory
system, such as: asthma, emphysema, COPD
)chronic obstructive pulmonary disease(, or
cough accompanied by a lot of phlegm )see
also section “Do not use the medicine”(.
If you are taking, or have recently taken,
other medicines, including non-prescription
medicines and nutritional supplements, tell
the doctor or pharmacist. Especially, inform
the doctor or pharmacist if you are taking:
medicines that affect the central nervous
system )such as: sedatives, hypnotics,
medicines for Parkinson’s, epilepsy, allergy,
surgical anesthetics and narcotic analgesics(.
antidepressants of the monoamine oxidase
inhibitor or SSRI type )see also section “Do
not use the medicine”(.
antihypertensives and heart medicines )such
as beta blockers(.
medicines for migraine.
cold-treating medicines and/or medicines for
Do not drink wine or alcoholic beverages during
treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do not use
Driving and operating machinery
Using the medicine can impair alertness and/or
vision. Therefore, you must exercise caution when
driving a car, operating dangerous machinery,
and during any activity that requires alertness.
Children must be cautioned against riding a
bicycle or playing near the road and the like.
If you smoke - report this to the doctor before
starting treatment with this medicine.
Important information regarding some of
the ingredients of the medicine:
This medicine contains sugar and sodium.
3. HOW SHOULD YOU USE THE MEDICINE?
Check with the doctor or pharmacist if you are
uncertain about how to use this medicine.
The usual dosage is generally:
Adults and children over 12 years of age:
10 ml x
3 times a day and 10 ml in the evening
Children 6-12 years of age:
5 ml x
3 times a day,
half an hour before meals.
Children from 1 year to 6 years of age: dosage
will be determined according to the doctor’s
Do not exceed the recommended dose.
This medicine is not intended for children and
infants under 1 year of age.
Refer to a doctor if your condition does not
improve within 7 days.
Method of administration:
1. With liquid medicines, you must use the
measuring spoon, syringe or dropper
designated for measuring the correct amount
of medicine. Consult a pharmacist if a spoon
or other measuring device has not been
enclosed. Do not use a household teaspoon
to measure the amount of the medicine.
Household teaspoons vary in their sizes
and you may not get the correct amount of
medicine. Rinse the measuring spoon after
2. Child-proof caps have significantly reduced
the number of cases of medicine-induced
poisoning annually. However, if you find it
difficult to open the container, you can ask the
pharmacist to remove the safety mechanism
of the cap and make it a regular, easy to open
If you accidentally took a higher dosage, or if
a child has accidentally swallowed the medicine,
refer immediately to a doctor or proceed to a
hospital emergency room and bring the package
of the medicine with you.
If you forgot to take the medicine at the required
time, do not take a double dose. Take the next
dose at the usual time and consult a doctor.
Do not take medicines in the dark! Check the label
and the dose each time you take the medicine.
Wear glasses if you need them.
If you have further questions regarding use of the
medicine, consult a doctor or pharmacist.
4. SIDE EFFECTS
As with any medicine, use of Tussophedrine NF
may cause side effects in some users. Do not be
alarmed when reading the list of side effects. You
may not suffer from any of them.
Discontinue use and refer to a doctor if the
following effects develop:
Sudden signs of allergy, such as: rash,
itching, fever, swelling of the throat, face,
lips, eyelids, tongue and/or other parts of the
body, shortness of breath/difficulty breathing,
Sensation of cold in the tips of hands or legs,
nausea, decrease/increase in heart rate.
Additional side effects:
Common side effects:
Dizziness, stomach upset, drowsiness.
Side effects of unknown frequency:
Headache, dry mouth, constipation.
If one of the side effects worsens or if you suffer
from a side effect not mentioned in this leaflet,
you must consult a doctor.
Side effects and drug interactions in
Parents must inform the attending doctor about
any side effects, as well as any additional
medicine being given to the child!
Avoid poisoning! This medicine and any other
medicine must be kept in a safe place out of
the reach of children and/or infants to avoid
poisoning. Do not induce vomiting unless
explicitly instructed to do so by the doctor.
Do not use the medicine after the expiry date
)exp. date( appearing on the package/label.
The expiry date refers to the last day of that
Store in a cool and dark place below 25°C.
Use the preparation within 6 months after first
6. FURTHER INFORMATION
In addition to the active ingredients, the
medicine also contains:
Purified water, sucrose, honey 375 mg, alcohol
96%, caramel, citric acid anhydrous, vanillin,
orange flavor, cherry flavor, eucalyptus oil.
Each 5 ml of syrup contains 3 grams of sucrose
and 3.2 mg sodium.
What does the medicine look like and what
are the contents of the package?
The package contains 115 ml of caramel-brown
Manufacturer and registration holder: Trima
Israel Pharmaceutical Products Maabarot Ltd.,
Maabarot 4023000 Israel.
This leaflet was checked and approved by the
Ministry of Health in July 2014.
Registration number of the medicine in the
National Drug Registry of the Ministry of Health: