Non-Classical Antihistamines

Contact: BGIVD Enquiries

Labelling Standard

I) Description:

This labelling standard applies to products containing histamine H1-receptor antagonist ingredients for OTC oral use as antihistamines.

II) Medicinal Ingredients:

1. Loratadine
2. Cetirizine

All subject to the requirements of Division 8, Part C of the Food and Drug Regulations.

III) Adequate Directions for Use:

1. Indications:
   
   
   1. For the relief of hayfever and allergy symptoms:
      
      
      1. sneezing
      2. runny nose
      3. itchy, watery eyes
      4. allergic skin conditions such as hives

IV) Miscellaneous Label Statement:

1. Product Monograph available to physicians and pharmacists on request
   
2. Other claims:
   
   
   1. Non-drowsy/Non-sedating:
      
      
      • See the Drugs Directorate Policy entitled "Absence of Side Effect Claims for Nonprescription Drugs".

References:

1. Compendium of Pharmaceutical Specialties, Twenty-sixth edition, 1991.
2. Drug Evaluations Subscription, American Medical Association, 1990.
3. United States Pharmacopoeia Dispensing Information, USPDI 1992, Drug Information for the Health Care Professional.
4. Martindale, The Extra Pharmacopoeia, 29th Edition, 1990, Philadelphia College of Pharmaceutical Sciences.
5. Canadian Drug Identification Code, Eighteenth Edition, 1992, Health and Welfare Canada.

Loratadine

I) Description

This labelling standard applies to products that contains loratadine as a single medicinal ingredient in the pharmaceutical form of a tablet or syrup.

II) Medicinal Ingredients and Concentrations

1. Loratadine 10 mg per tablet
2. Loratadine syrup 1 mg per ml

III) Adequate Directions for Use

1. Indications:
   
   
   1. As for all ingredients (see page 1).
      
2. Dosage Directions:
   
   
   1. Tablets:
      
      
      • Adults and children 12 years of age and over: One tablet, (10 mg) once per day.
        
   2. Syrup:
      
      
      1. Adults and children 10 years of age and over (body weight greater than 30 kg): 10 ml (two teaspoonfuls) of syrup once per day
         
      2. Children 2 to 9 years of age (body weight less than or equal to 30 kg): 5 ml (one teaspoonful) of syrup once per day
         
      3. Not recommended for children under two years of age
         
      4. Use by children between the ages of 2 and 12 for longer than 14 days, use only as directed by a doctor
3. Warnings:
   
   
   1. "DO NOT EXCEED RECOMMENDED DOSAGE" should immediately follow the dosage directions.
   2. Prolonged usage should be only on the advice and direction of a physician.
   3. Pregnant or nursing mothers should not use this product, unless advised by a physician.

Cetirizine

I) Description

This labelling standard applies to products that contains Cetirizine as a single medicinal ingredient in the pharmaceutical form of a tablet.

II) Medicinal Ingredients and Concentrations

1. Cetirizine 5 and 10 mg per tablet

III) Adequate Directions for Use:

1. Indications:
   
   
   1. As for all ingredients (see page 1).
      
2. Dosage Directions:
   
   
   1. Adults and children 12 years of age and over: one tablet, (5 or 10 mg) once per day. Elderly patients take one 5 mg tablet per day or consult a physician
      
3. Warnings:
   
   
   1. "DO NOT EXCEED RECOMMENDED DOSAGE" should immediately follow the dosage directions.
   2. Prolonged usage should be only on the advice and direction of a physician.
   3. Pregnant or nursing mothers and those with liver or kidney disease should consult a physician before use.
   4. Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery.