FORMULA:
Each Tylol Hot Pediatric Sachet contains;
Paracetamol (micronised) 250 mg
Chlorpheniramine maleate 2 mg
Pseudoephedrine hydrochloride 30 mg
Sugar and orange flavour as sweetener.

PHARMACOLOGICAL PROPERTIES:
Paracetamol is a clinically proven analgesic and antipyretic. It produces analgesia by elevating the pain threshold and antipyresis by acting on the thermo-regulatory center in the hypothalamus.
Chlorpheniramine maleate has an antagonistic property against histamine H1-receptor, thus relieves following symptoms; rhinorrhea, nasal congestion, redness and/or hypersensitivity of eyes.
Pseudoephedrine hydrochloride is a sympathomimetic amine which has a strong decongestant property on upper respiratory tract.

INDICATIONS:
Tylol Hot Pediatric Sachet is indicated for the symptomatic relief of influenza and common cold.

CONTRAINDICATIONS:
Tylol Hot Pediatric Sachet should not be used in patients hypersensitive to any of the ingredients of it.
Also, patients presenting severe hepatic and renal illness, should not use this medication. Prior to Tylol Hot Pediatric Sachet administration, patients should be informed about not to take Monoamine oxidase inhibitors together and it had to be dropped out 2 weeks before the onset of Tylol Hot Pediatric Sachet administration.

DRUG INTERACTIONS and OTHER INTERACTIONS:
It potentiates the effects of anticoagulants with prolonged therapy at higher doses. Blood pressure elevation may occur occasionally in case of pseudoephedrine hydrochloride co-administration with decongestants, tricyclic antidepressants, anti-appetizers, amphetamine like psychostimulants and MAO inhibitors.

WARNINGS / PRECAUTIONS:
Tylol Hot Pediatric Sachet should not be used more than 5 days in children for the management of pain and should not be administered for treating recurrent febrile conditions continuing for more than 3 days above 39.5°C unless advised by the physician.
Children below 6 years of age, should use Tylol Hot Pediatric Sachet only under the supervision of a physician.

DOSAGE and ADMINISTRATION:
Tylol Hot Pediatric Sachet is taken orally as directed below:
Ingredient of each packet should be dissolved in a hot water of 80 ml (=half of a standard size cup) and immediately be drunk without waiting. A period of 6 hours should be considered in case of adjacent administration. Recommended maximum daily dose is 4 sachets.

OVERDOSE:
If overdose is suspected, the patient should be immediately taken to a health care center.
Paracetamol may cause hepatotoxicity in case of overdosage in some patients. It is due to the amount of drug ingested.
It is recommended that acetylcysteine administration should be instituted as soon as possible after ingestion of an overdose has been reported, without waiting for the results of plasma paracetamol determinations.
Chlorpheniramine toxicity becomes overt in few hours after ingestion; treatment should be applied as written in antihistaminic/anticholinergic overdose treatment schema.
Pseudoephedrine overdose related symptoms are mild anxiety, tachycardia and/or mild hypertension. Symptoms become overt following 4 to 8 hours after ingestion. All symptoms are temporary and no specific treatment is required.

HOW SUPPLIED:
Tylol Hot Pediatric Sachet: In packages of 12 sachets.

OTHER PHARMACEUTICAL DOSAGE FORMS:
Tylol Hot Sachet: In packages of 12 sachets.
Tylol Hot D Sachet: In packages of 12 sachets.