Anti-Cold syrup with orange flavour

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Descargar Fitxa tècnica (SPC)
14-12-2017

ingredients actius:

paracetamol, chlorpheniramine (chlorpheniramine maleate), phenylpropanolamine (phenylpropanolamine hydrochloride)

Disponible des:

Arpimed LLC

Codi ATC:

N02BE51

Designació comuna internacional (DCI):

paracetamol, chlorpheniramine (chlorpheniramine maleate), phenylpropanolamine (phenylpropanolamine hydrochloride)

Dosis:

32mg/ml+ 0,2mg/ml+ 1mg/ml

formulario farmacéutico:

syrup with orange flavour

Unidades en paquete:

60ml glass bottle

tipo de receta:

OTC

Estat d'Autorització:

Registered

Data d'autorització:

2017-12-12

Fitxa tècnica

                                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
                                
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