CONTRAINDICATIONS SECTION.
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.
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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.
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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.
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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.
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OTC - ACTIVE INGREDIENT SECTION.
Active Ingredient. paracetamol 325.0 mgpheniramine maleate 20.0 mgphenylephrine hydrochloride 10.0 mg.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children.
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OTC - PURPOSE SECTION.
Purpose. AntipyreticAnalgesicVasoconstrictiveDecongestantAntiallergic. Antipyretic. Analgesic. Vasoconstrictive. Decongestant. Antiallergic.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. NDC 0067-0924-01THERAFLUCOLD FLUcontains paracetamol 325 mgFEVER MUSCLE PAINHEADACHE RUNNYNOSESORE THROAT NASAL CONGESTIONCHILLS SNEEZINGBerry flavour10 SACHETS. FEVER MUSCLE PAIN. HEADACHE RUNNYNOSE. SORE THROAT NASAL CONGESTION. CHILLS SNEEZING. Theraflu Cold and Flu Berry.
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SPL UNCLASSIFIED SECTION.
TheraFlu Cold and Flu. Pharmaceutical form:Powder for oral solution (berry flavor).
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STORAGE AND HANDLING SECTION.
Storage conditions:. At temperature not higher than 25C.
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