GUAPHANDM®
SYRUP
100ML
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COMPOSITION: Syrup: Each 5 ml contains Guaifenesin (EP) 100 mg and Dextromethorphan Hydrobromide (USP) 10 mg. CLINICAL PHARMACOLOGY: Guaifenesin reduces the adhesiveness and surface tension of respiratory tract secretions, thereby easing their expectoration .Expectorant effect can reduce cough frequency. Dextromethorphan Hydrobromide acts centrally and elevates the threshold for coughing. In therapeutic dosage, Dextromethorphan Hydrobromide dose not inhibit ciliary activity. INDICATIONS: GUAPHAN OM has temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. CONTRAINDICATIONS: Do not take this product if you are hypersensitive to any of the ingredients. This medication should not be used for treatment of cough and cold symptoms in children under 6 years of age.
Parkinson disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a physician before taking this product.
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DURING PREGNANCY AND LACTATION: As with any drug, if you are pregnant or nursing a baby, seek the advice of a physician before using this product. DOSAGE: Adults and children 12 years and over: 10 ml every 4 hours. Children: 6 years to under 12 years: 5 ml every 4 hours. Do no exceed 6 doses in a 24 J period.
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STORAGE: Store at room temperature (15-25) °C. Do not use the drug after the expiry date printed on the package. PRESENTATION:
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100 ml bo Ie.
To Report any side effect(s) or Quality Problems:
ADVERSE REACTIONS: Drowsiness, dizziness and gastrointestinal disturbances.
"ational Pharmacovigilance Center , PC) • Fax: +96&-1-205-7662 • E-mail: npc.drug@sfdagov.sa • website: www.sfda.gov.salnpc
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WARNING: e A0 tak-e his product for pers~tent~or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by physician. A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a physician. PRECAUTION~:~_~ __ Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or
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Medical and Cosmetic Products Co. Ltd. Riyadh, Saudi Arabia.
June 2011
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