País: Armènia
Idioma: anglès
Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paracetamol, chlorpheniramine (chlorpheniramine maleate), phenylpropanolamine (phenylpropanolamine hydrochloride)
Arpimed LLC
N02BE51
paracetamol, chlorpheniramine (chlorpheniramine maleate), phenylpropanolamine (phenylpropanolamine hydrochloride)
32mg/ml+ 0,2mg/ml+ 1mg/ml
syrup with orange flavour
60ml glass bottle
OTC
Registered
2017-12-12
SUMMARY PRODUCT CHARACTERISTIC (SPC) ANTI-COLD ® SYRUP 1.1 BRAND NAME – ANTI-COLD 1.2 INTERNATIONAL NON-PROPERTY NAME – PARACETAMOL / PHENYLPROPANOLAMINE / CHLORPHENIRAMINE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL syrup contains: _ACTIVE INGREDIENTS:_ Paracetamol - 160 mg, Phenylpropanolamine hydrochloride – 5 mg, Chlorpheniramine maleate – 1 mg; _For a full list of excipients, see section 6.1. _ 3. PHARMACEUTICAL FORM Syrup. A clear yellow colored, flavored (orange) syrup. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is used for the relief of clogged nose, runny nose, postnasal drip, itchy and watery eyes, sneezing, headache, body aches, and fever associated with the common cold, allergic rhinitis, sinusitis, flu, and other minor respiratory tract infections. It also helps decongest sinus openings and passages. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and children over 12 years of age: _15 mL (3 teaspoonful). _Children 7-12 years: _10 mL (2 teaspoonful) _Children 2-6 years: _5 mL (1 teaspoonful) _Children 1-2 years: _As prescribed by the physician. To be given orally every 6 hrs, or as prescribed by the physician. 4.3 CONTRAINDICATIONS Allergy to any ingredient in the product Anemia, kidney or liver disease unless recommended by a doctor Pregnancy or breastfeeding This drug is contraindicated for children younger than 1 years of age. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE • Use with caution in patients with high blood pressure, toxic goiter, benign prostatic hypertrophy, heart rate irregularity, glaucoma, and in those taking antidepressants. • Patients with heart disease and uncontrolled/untreated high blood pressure should consult a doctor prior to taking phenylpropanolamine. • Liver Warning: This product contains paracetamol. Severe liver damage may occur if patient takes: • More than 4 g of paracetamol in 24 hours, which is the maximum daily amount; • With other medicines containing paracetamol (or acetaminophen); • 3 or mor Llegiu el document complet