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OTC - Ameflu - Cough and cold preparations - New Ameflu Expectorant

COMPOSITION: Each 5 ml syrup contains:

Active ingredient:

– 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..


INDICATIONS:

  • 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.


CONTRAINDICATIONS:

  • 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.


SIDE EFFECTS:

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.


INTERACTIONS:

  • 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.

Phenylephrine HCl:

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

Manufacturer:

OPV PHARMACEUTICAL JOINT STOCK COMPANY

Lot 27, Road 3A, Bien Hoa Industrial Zone II, Dong Nai Province.

Tel : (061) 3992999    Fax: (061) 3835088