PHENYLEPHRINE HCI CHLORPHENAMINE MALEATE DISUDRIN® 5 mg/1mg per 5 mL Syrup 2.5 mg /0.5 mg per mL Syrup (Oral Drops) Nasal Decongestant / Antihistamine FORMULATIONS Each ml. syrup (oral drops) contains: Phenylephrine HCI. son 25.9 Chlorphenamine maleate... SINGS mg Each Sb (t teaspgonfu sup contains Phenylephrine HCI. erscnnssnm snnene 5M Chlorphenamine maleate... : 22 mg PRODUCT DESCRIPTIONS Prenfentvne HC + Clopheraine maleate (Dsudn®) Syrup (Oral Drops san orange, csr syrup ith range tt, Phenylephrine HCI + Chlorphenamine maleate (Disudrin® Syrup is an orange, clear syrup with fruity taste, WHAT IS IN THE MEDICINE? ‘These medicines contain Phenylephrine HCI and Chlorphenamine maleate. Phenylephrine HCl, a nasal decongestant, clears obstructed air passages and nasal sinuses due to congestion making breathing easier. It also reduces postnasal drip. Chlorphenamine maleate, an anti-allergy, relieves symptoms of allergy such as runny nose, sneezing, and itchy, watery eyes. STRENGTH OF THE MEDICINE See Formulations WHAT IS THIS MEDICINE USED FOR? These medicines are used for the relief of clogged nose, runny nose, itchy, watery eyes, and sneezing associated with the common cold, upper airway cough syndrome (postnasal drip syndrome), allergic rhinitis, and other minor respiratory tract, infections, They also help decongest sinus openings and passages. HOW MUCH AND HOW OFTEN SHOULD YOU USE THIS MEDICINE? These medicines should be taken orally by mouth). Oral Dose of Phenylephrine HCI + Chlorphenamine maleate (Disudrin*) every 6 hours ‘Age Group 25mg7/0.5 mg per mL Smg/1mg perS mL ‘Syrup (Oral Drops) syrup Children {to 3 months 0.25 mL 410 6 months 05 mt To 12 months O75mi 1 to 2 years Tmb 2t0 6 years 25 mL (12 teaspoonful) To 12 years 5 mL (1 teaspoonful) Children 12 years and oder and Adults 10 ml (2 teaspoonsful) Or, as recommended by a doctor. WHEN SHOULD YOU NOT TAKE THIS MEDI INE? + Ifyou are allergic to any ingredient in the product + Ifyou have high blood pressure or severe heart disease unless recommended by a doctor + IF you are pregnant or breastfeeding UNDESIRABLE EFFECTS Phenylephrine HCI may cause tremors (muscle shaking), restlesness, arvity (feeling of uneasnes),insormiafleeplesness, nervousness, dizziness increased blood presure, palpitation (rapid and regula heartbeat), athythmia (irregular heartbeat), weakness, respiratory ditess (noisy, congested breathing), and par (oaleskin colo).Chlorphenamine maleate may cause sleepiness and drowsiness Other undesable effec include musde weakness, gast ointstnal ciscomfort, nausea, vomiting, diarthea or constipation, dryness of the mouth, nose, and throat, difficulty urinating ringing in the ears, visual disturbance blued vision insomniafleeplesmess, tremors nervousness tabi ches tightness increased or decreased bloodpressure, and headache. WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE? Do not use this product together with sympathomimetic agents (e.g, Epinephrine, etc) and general anesthetics (e.g,, Halothane, etc) because of the possibilty for increased toxic Concurrent administration with medicines for depression (eq, Amitriptyline, Imipramine, Sertraline, Mocobemide, et.) may result in Iypertesve cis uden eee ince inbood presets an ad toot) Taking an adrenergic blocking agent (eg, Phenothiazine drugs, Phentolamine, Propranolol et) before the administration ofthis product ‘may decrease the effect of phenylephrine Tell your doctor about other medicines the chilis taking, espedelly ther medicines for cough, cold or allergy. WHAT SHOULD YOU DO IF YOU MISS A DOSE? if you miss @ dose, just take the next dose if til needed for the condition being treated, and the subsequent doses at the recommended time or schedule ie, every 6 hours) Do not double the dose. HOW SHOULD YOU KEEP THIS MEDICINE? Keep the product out of reach and sight of children Store at temperatures not exceeding 30°C SIGNS AND SYMPTOMS OF OVERDOSAGE Phenylephrine HCl * Increased blood pressure * Headache * Seizures * Palptation aretha (esation of ring prkkng, or umes of the sk) * Vomiting Cerebral hemorrhage (bleeding from a ruptured blood vessel inthe brain) Chlorphenamine maleate + Extreme sleepiness or prolonged drowsiness * Weakness Hallucination + Convubion * Agitation ——_* Initabilty + Tachycardia (fast heart rate) * Coma WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE? if you have taken more than the recommended dosage, consult a doctor. ‘CARE THAT SHOULD BE TAKEN WHEN TAKING THIS MEDI +” May cause drowsiness; patients should observe caution while driving or + Donot use after the expiry date on the label WHEN SHOULD YOU CONSULT YOUR DOCTOR? Before taking this medication tell your doctor if you have ‘+ High blood pressure or any type of heart problems * Glaucoma + Thyroid problems * Diabetes + Anenlarged prostate, bladder problems or difficulty urinating ifsymptoms do not improve or new symptoms appear AVAILABILITY Phenylephrine HCl + Chlorphenamine maleate (Disudrin®) 2.5 mg/0.5 mg per ml Syrup (Oral Drops) ~ in amber bottle of 10 mL Phenylephrine HCl + Chlorphenamine maleate (Disudrin ®) 5 mg / 1 mg per5 ml. Syrup in amber bottle of 60 mL & 120 mL DATE OF FIRST AUTHO! IN (DR-XY¥29955): March 2011 DATE OF FIRST AUTHORIZATION (DR-XY33744): March 2011 DATE OF REVISION OF PATIENT INFORMATION LEAFLET (PIL): April 2011 ADVERSE DRUG REACTION REPORTING STATEMENT For suspected adverse drug reaction, seek medical attention immediately and report to the FDA at www.fda.gov.oh AND Unilab at (+632) 858-1000 or [email protected]. By reporting undesirable effects, you can help provide more information on the safety of this medicine, INE forming other tasks requiring alertness Manufactured by AMHERST LABORATORIES, INC. UNILAB Pharma Campus, Barangay Mamplasan Bian, Laguna, Philippines for UNI , ne. No. 66 United Street, Mandaluyong City, Metro Manila, Pilippines Trusted Quality Healthca