CLARITYNE Syrup / Tablet Ref.[51096] Active ingredients: Loratadine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2018  Publisher: Bayer (Pty) Ltd, 27 Wrench Road, Isando, 1600, SOUTH AFRICA 1968/011192/07 +27 11 921 5000

Product name and form

CLARITYNE Syrup, (Syrup).

CLARITYNE Tablets, (Tablet).

Pharmaceutical Form

CLARITYNE Syrup: Clear, colourless to light-yellow syrup, with a characteristic peach odour and flavour, and free from foreign matter.

CLARITYNE Tablets: Oval, convex, white tablet, scored on one side with the trademark above the score, and the number 10 below the score.

Qualitative and quantitative composition

CLARITYNE Syrup per 5 ml

Active ingredients: 5 mg of loratadine (micronized).

Inactive ingredients: Citric acid monohydrate, glycerol, peach flavor, propylene glycol, purified water and sucrose.

Preservative: Sodium benzoate 0,1% m/v.

Contains sugar: Sucrose. 3.0 g.

CLARITYNE Tablets per tablet

Active ingredient: 10 mg loratadine (micronized).

Inactive ingredients: Lactose monohydrate, magnesium stearate, maize starch and purified water.

Contains sugar: Lactose monohydrate 0.071 g/tablet.

Active Ingredient Description
Loratadine

Loratadine is a tricyclic antihistamine with selective, peripheral H1-receptor activity. Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.

List of Excipients

Pack sizes and marketing

CLARITYNE Syrup: Bottles of 100 ml.

CLARITYNE Tablets: Blister packs of 10 and 30 tablets.

Marketing authorization holder

Bayer (Pty) Ltd, 27 Wrench Road, Isando, 1600, SOUTH AFRICA
1968/011192/07
+27 11 921 5000

Marketing authorization dates and numbers

CLARITYNE Syrup: Z/5.7.1/56

CLARITYNE Tablets: U/5.7.1/27

CLARITYNE Syrup:

Date on the registration certificate: 15 January 1992

CLARITYNE Tablets:

Date on the registration certificate: 03 October 1990

Drugs

Drug Countries
CLARITYNE Austria, Cyprus, Ecuador, Spain, France, Hong Kong, Malta, Mexico, Nigeria, Singapore, South Africa

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