Label Statements Database

Edition 1.8 (May 2012)

This database lists the warning and advisory statements that are required on medicine and related product labels under regulations 13(1)(i) and 14(1)(f) of the Medicines Regulations 1984. Words of a similar meaning to the statements in the database may be used and individual statements may be combined provided the intent is not changed.

The full set of labelling requirements for medicines is specified in the Medicines Regulations 1984 and described in the Medsafe guidance document Guideline on the Regulation of Therapeutic Products in New Zealand, Part 5: Labelling of Medicines and Related Products.

Each label statement for a medicine or related product has a "required by" date. This is the date on which inclusion of the statement on labels becomes mandatory. Those label statements that were required prior to August 2011 have been given a "required by" date of 1 August 2011.

The "required by" date for future statements will generally be one year from the date on which the statement was added to the database, to allow distributors to amend product labels.

Required label statements will only be added to the database following consultation with affected parties. In cases where a required label statement is added as the result of a recommendation from the Medicines Classification Committee, consultation will occur through the normal Medicines Classification Committee process.

Unless specifically indicated, the statements do not apply to prescription medicines.

Unless indicated otherwise, the label statements are required for all products containing any proportion of the named ingredient or any form of that ingredient.

In this database "For oral use" means the product is swallowed.

* Substances marked with an asterisk (*) also require statements of their own in addition to those applicable to their group or class.

Medicine/Group/Class

Conditions

Statements or requirements

Required by

5HT1 agonists
Includes:

Rizatriptan
Sumatriptan
Zolmitriptan

Chronic use can result in a rebound headache.
Do not use if you have an irregular heartbeat.
Do not use if you are allergic to sulfonamides.
Do not use with other migraine medications except on doctor's advice.
Do not use if you are pregnant except on doctor's advice.

1/08/2011

Acetaminophen

(Paracetamol)

see Paracetamol

Acetylsalicylic acid

(Aspirin)

see Aspirin

Alclometasone

see Corticosteroids, topical

Alcohol

(Ethanol)

see Ethanol

Alimemazine

see Antihistamines, sedating

Antihistamines, non-sedating
Includes:

Cetirizine*
Desloratadine
Fexofenadine*
Levocetirizine
Loratadine*
Rupatadine

For oral use

Although this medicine is unlikely to affect your ability to drive or operate machinery, a few people may be impaired and care should be taken.

1/08/2011

In cough and cold medicines

Do not use in children under 6 years old.
Consult a healthcare professional before using in children aged six years and over.
Do not use with other antihistamines.
Do not use with other medicines intended to treat the symptoms of the common cold.
[or]
Consult a doctor/pharmacist before using with other medicines intended to treat the symptoms of the common cold.

1/08/2011

Antihistamines, sedating
Includes:

Alimemazine
Brompheniramine
Chlorphenamine
Cyclizine
Dexchlorpheniramine
Diphenhydramine
Doxylamine
Ketotifen
Meclozine
Mepyramine
Pheniramine
Promethazine

For oral use

This medicine may cause drowsiness.
Be cautious about driving a vehicle or operating machinery within 8 hours of taking this medicine.

1/08/2011

In cough and cold medicines

Do not use in children under 6 years old.
Consult a healthcare professional before using in children aged six years and over.
Do not use with other antihistamines.
Do not use with other medicines intended to treat the symptoms of the common cold.
[or]
Consult a doctor/pharmacist before using with other medicines intended to treat the symptoms of the common cold.

1/08/2011

For the treatment of insomnia or anxiety

Do not use in children under 12 years old.
Do not exceed the maximum stated dose.
This product is for temporary use only. [or] For short term use only.
Consult a doctor if sleeplessness (or anxiety) persists.

1/08/2011

Antitussives
Includes:

Dextromethorphan
Pholcodine

In cough and cold medicines

Do not use in children under 6 years old.
Consult a healthcare professional before using in children aged six years and over.
Do not use with other medicines intended to treat the symptoms of the common cold.
[or]
Consult a doctor/pharmacist before using with other medicines intended to treat the symptoms of the common cold.

1/08/2011

Aspirin

For oral use

Do not use in children under 12 years of age except on doctor's advice.
Do not use for more than a few days at a time except on doctor's advice.
Prolonged or excessive use can be harmful.

1/08/2011

[or]

Unless a doctor has told you to, do not use this product in children under 12 years of age or teenagers with chickenpox, influenza or fever..
Unless a doctor has told you to do not use if you have asthma.
Do not use this product if you have a stomach ulcer, or are allergic to aspirin or anti-inflammatory medicines. If you get an allergic reaction stop taking and see your doctor immediately.
Unless a doctor has told you to, do not use this product for more than a few days at a time. Warning - Prolonged or excessive use can be harmful.
Do not use with other medicines containing aspirin or other anti-inflammatory medicines that you are taking regularly unless advised to do so by a doctor or pharmacist.
Do not use this product during the first 6 months of pregnancy, except on doctor's advice. Do not use at all during the last 3 months of pregnancy.

12/09/2012

Beclometasone

see Corticosteroids, nasal

Beclomethasone

(Beclometasone)

see Beclometasone

Bromhexine

see Mucolytics/Expectorants

Brompheniramine

see Antihistamines, sedating

Budesonide

see Corticosteroids, nasal

Bufexamac

For dermal use

If you get an allergic reaction stop taking and see your doctor immediately.
Local skin irritations may occur with the use of [name of active substance].
Do not use in children under 2 years old.
Do not use under bandages or dressings.
Do not use on broken or blistered skin.
Do not use for the treatment of chronic or recurring skin conditions.
Do not use on large areas of skin except on the advice of a healthcare professional.
Do not use if you have previously had an allergic reaction to any of the ingredients.
Do not use for more than 7 days at a time, except on doctor's advice.
Avoid contact with eyes and mouth.
Consult a healthcare professional before use if you have a current or past history of skin allergy or irritation.
Consult a doctor if symptoms/condition persist(s), worsens or recur.

1/08/2011

Cetirizine

When sold as a General Sale Medicine

Do not use in children under 12 years old.
Do not use for more than 5 days at a time.
Do not use with other antihistamines.
Consult a healthcare professional before use if you have kidney problems or impaired renal function.
Do not use if you are pregnant except on the advice of a healthcare professional.
Do not use if you are breastfeeding except on the advice of a healthcare professional.

2/02/2013

REGULATORY INFORMATION

Label Statements Database

Edition 1.8 (May 2012)