COMPOSITION: Each 5 ml syrup contains:
– Guaifenesin ………………. 50 mg
– Phenylephrine HCl ………..5 mg
Excipients: Propylen glycol, citric acid, sodium benzoate, glycerine, sorbitol 70%, orange flavor, tartrazine, quinoline yellow, sucralose, purified water..
- Helps loosen phlegm (mucus) and thins bronchial secretions to make coughs more productive.
- Temporarily relieves nasal cavity and sinus congestion (stuffy), runny nose as may occur with a cold.
ADMINISTRATION AND DOSAGE:
- Children under 4 years of age: directed by a doctor.
- Children from 4 to under 6 years of age: take ½ teaspoon (2.5 ml), every 4 hours.
- Children from 6 to under 12 years of age: take 1 teaspoon (5 ml), every 4 hours.
- Children over 12 years of age and adult: take 1-2 teaspoon (5-10 ml), every 4 hours.
Do not take more than 6 doses in 24 hours unless directed by doctor.
- The patients who are sensitive to any ingredients of this product.
- Patients who are receiving MAOIs (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease).
WARNINGS AND PRECAUTIONS:
Children under 4 years of age.
Do not exceed recommended dosage.
- If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
- If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
- A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
Do not take this product, unless directed by a doctor:
- For persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (sputum), or
- If you have heart disease, high blood pressure, thyroid disease, diabetes, on digitalis, a breathing problem such as emphysema or chronic bronchitis, or difficulty in urination due to enlargement of the prostate gland, liver or kidney failure.
- Elderly patient.
Effects on ability to drive and operate machine: Use caution when driving vehicle or operating machinery.
Use in pregnancy and lactation: As with any drug, if you are pregnant or nursing a baby, consult a doctor before using this product.
Fast, pounding, or uneven heartbeat, severe dizziness, anxiety, restless feeling, fever, chills, hypertension, sleep problems (insomnia), headache, weakness, pale skin, hallucinations.
These signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
In case of an unexpected reaction, consult your physician.
- Do not take this product if you are now taking a prescription of monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.
- Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs (including debrisoquine, guanethidine, reserpine, methyldopa). The risk of hypertension and other cardiovascular side effects may be increased.
- Tricyclic antidepressants (e.g. amitriptyline, imipramine): May increase the risk of cardiovascular side effects with phenylephrine.
- Concomitant use of phenylephrine with ergot alkaloids (ergotamine and methylsergide): Increase the risk of ergotism.
Concomitant use of phenylephrine with digoxin: Increase the risk of irregular heartbeat or heart attack.
OVERDOSAGE AND TREATMENT:
An overdose of Guaifenesin is not likely to cause life-threatening symptoms.
Symptoms: Hypertension, headache, convulsions, cerebral heamorrhage, palpitation, slow heart rate.
Treatment: Should provide symptomatic and supportive care.
PRESENTATION: Bottle of 30 ml or 60 ml.
STORAGE: Store at temperature from 15oC to 30oC.
SHELF-LIFE: 36 months from manufacturing date. Do not use after expiry date.
DATE OF REVISION OF PACKAGE INSERT:
KEEP OUT OF REACH OF CHILDREN
READ THE ENCLOSED INSERT CAREFULLY BEFORE USE
DO NOT EXCEED RECOMMENDED DOSAGE
FOR FURTHER INFORMATION, CONSULT YOUR PHYSICIAN
Manufactured with technology from:
Ameripharm – USA
OPV PHARMACEUTICAL JOINT STOCK COMPANY
Lot 27, Road 3A, Bien Hoa Industrial Zone II, Dong Nai Province.
Tel : (061) 3992999 Fax: (061) 3835088