This document provides information about the drug GUAPHANOM 100ML SYRUP. It contains guaifenesin to reduce cough frequency and dextromethorphan hydrobromide to elevate the cough threshold. It temporarily relieves coughs due to minor throat and bronchial irritation from colds. It should not be used for persistent coughs without a doctor's guidance or by children under 6 years old. Common side effects include drowsiness, dizziness and gastrointestinal issues. Precautions are outlined around use in pregnancy, lactation, with other medications, and maximum daily dosage.

1. GUAPHANDM® 100ML SYRUP
WARNING: !)j'-i~~~;:;:;;;;;:~-;;;;~;;;;==~e A0 tak-e his product for pers~tent~or ThisIs. _
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
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.
ADVERSE REACTIONS:
Drowsiness, dizziness and gastrointestinal
disturbances.
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.
+use 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. -
STORAGE:
Store at room temperature (15-25) °C.
Do not use the drug after the expiry
date printed on the package.
PRESENTATION:
100 ml bo Ie.
To Report any side effect(s) or Quality Problems:
"ational Pharmacovigilance Center , PC)
• Fax: +96&-1-205-7662
• E-mail: npc.drug@sfdagov.sa
• website: www.sfda.gov.salnpc
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PliARMA -
Manufactured by RIYADH PHARMA
Medical and Cosmetic Products Co. Ltd.
Riyadh, Saudi Arabia.
RIYADHrfl'HAlUlA I.:S:d
Revised June 2011 GUAPHAN OM is a trademark
ITEM CODE: PIL0441
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