STORAGE AND HANDLING SECTION.
Storage conditions: At temperature not higher than 25C.
Contraindications: Hypersensitivity to individual product ingredients, co-administration of tricyclic antidepressants, beta-adrenergic blockers or other sympathomimetic products, hyperthyroidism, pheochromocytoma, angle-closure glaucoma, alcoholism, pregnancy, breastfeeding, pediatric use under 12 years of age. For complete list of contraindications, see patient information leaflet.
DOSAGE & ADMINISTRATION SECTION.
Dosage and administration: For oral administration. Dissolve one sachet in glass of hot, but not boiling, water. Take hot.Take one sachet every - hours as required but not more than doses within 24 hours. The product should not be administered for more than days.Excipients: see patient information leaflet.
INACTIVE INGREDIENT SECTION.
Excipients:. sucrose, acesulfame potassium, Allura Red AC 129 (FD&C red No.40), Brilliant Blue 133 (FD&C No.1), maltodextrin, silicon dioxide, natural raspberry flavor WONF Durarome (860385 TD0994), natural cranberry Durarome flavor (861149 TD2590, citric acid anhydrous, sodium citrate dihydrate, calcium phosphate tribasic, magnesium stearate.
INDICATIONS & USAGE SECTION.
Indications: Symptomatic therapy of infectious and inflammatory disorders: acute respiratory viral infections (ARVI) including influenza and common cold associated with: high temperature, chill, headache, sore throat, rhinitis, nasal congestion, sneezing, muscle pain.
OTC - ACTIVE INGREDIENT SECTION.
Active Ingredient. paracetamol 325.0 mgpheniramine maleate 20.0 mgphenylephrine hydrochloride 10.0 mg.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children.
OTC - PURPOSE SECTION.
Purpose. Antipyretic Analgesic Vasoconstrictive Decongestant Antiallergic. Antipyretic. Analgesic. Vasoconstrictive Decongestant. Antiallergic.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel NDC 0067-0924-01THERAFLUCOLD FLUcontains paracetamol 325 mg FEVERMUSCLE PAIN HEADACHERUNNYNOSE SORE THROATNASAL CONGESTION CHILLSSNEEZINGBerry flavour10 SACHETS FEVERMUSCLE PAIN. HEADACHERUNNYNOSE. SORE THROATNASAL CONGESTION. CHILLSSNEEZING. Theraflu Cold and Flu Berry.
SPL UNCLASSIFIED SECTION.
TheraFlu Cold and Flu. Pharmaceutical form: Powder for oral solution (berry flavor).