SUMMARY CMI
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid contains the active ingredient Promethazine hydrochloride. Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid is used to treat a number of conditions: allergies - allergic contact dermatitis, hives, hayfever, bites and stings; respiratory symptoms due to allergies - runny nose; nausea and vomiting - motion sickness; sedation - for short-term use under the advice of a pharmacist or doctor.
For more information, see Section 1. Why am I using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid? in the full CMI.
2. What should I know before I use Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
Do not use if you have ever had an allergic reaction to Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid or any of the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
- Dosage varies according to the condition being treated and the individual's response.
- This product must not be used in children under 6 years of age.
More instructions can be found in Section 4. How do I use Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid? in the full CMI.
5. What should I know while using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid? in the full CMI.
6. Are there any side effects?
Side effects of promethazine associated with cholinergic blockage include dryness of the eyes, mouth and nose, blurred vision, urinary hesitancy and retention, constipation and tachycardia.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid
Active ingredient: Promethazine hydrochloride (PRO-meth-ar-zine HIGH-dro (h)-CLOR-ride)
Consumer Medicine Information (CMI)
This leaflet provides important information about using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid.
Where to find information in this leaflet:
1. Why am I using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
2. What should I know before I use Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
3. What if I am taking other medicine?
4. How do I use Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
5. What should I know while using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
6. Are there any side effects?
7. Product details
1. Why am I using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid contains the active ingredient Promethazine hydrochloride. Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid is an antihistamine used to treat a number of conditions:
- allergies - allergic contact dermatitis, hives, hayfever, bites and stings
- respiratory symptoms due to allergies - runny nose
- nausea and vomiting - motion sickness
- for short-term use for sedation on the advice of a pharmacist or doctor.
Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine. Histamine is produced by the body in response to foreign substances that the body is allergic to.
Your pharmacist or doctor may have recommended this medicine for another reason.
Ask your pharmacist or doctor if you have any questions about this medicine.
2. What should I know before I use Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
Warnings
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid must not be used in children under 6 years of age, due to the potential for fatal respiratory depression, psychiatric and CNS events.
Do not use Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid if:
- you are allergic to promethazine hydrochloride, medicines of similar properties or belonging to the specific family of chemicals called phenothiazines, or other phenothiazines, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin
If you take this medicine after the expiry date has passed, it may not work as well. - the packaging is torn or shows signs of tampering.
Any person who is unconscious or in a coma must not be treated with Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid.
Do not give Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid to newborn or premature babies.
Check with your doctor or pharmacist if you:
- have allergies to
- any other medicines
- any other substances, such as foods, preservatives or dyes - have or have had any medical conditions, especially the following:
- kidney or liver disease
- Parkinson's disease
- underactive thyroid gland (hypothyroidism)
- tumour growing in adrenal glands (pheochromocytoma)
- epilepsy
- cardiovascular disease/cardiac failure
- blood pressure problems
- low blood cell count (agranulocytosis)
- bladder problems
- breathing problems
- glaucoma - an eye condition
- prostate problems
- stomach ulcer or blockage - develop a fever or an infection to confirm if laboratory tests are required to check your blood count
- plan to have surgery
- take sedatives
- take any medicines for any other condition
- have any personal or family history of heart disease
- have an irregular heartbeat
If you experience an allergic reaction, seek medical help right away.
Caution must be exercised when using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 ml oral liquid.
If you experience fever, sore throat or any other infection, you should inform your doctor or pharmacist immediately and undergo a complete blood count. Treatment should be discontinued if any marked changes are observed in the blood count.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor or pharmacist if you are a woman of childbearing age and not using effective contraception.
Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.
Do not take Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid if you are pregnant or plan to become pregnant.
It may affect your developing baby if you take it during pregnancy. If there is a need to consider Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid during your pregnancy, your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Do not take Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid if you are breastfeeding or plan to breastfeed.
It passes into the breast milk and there is a possibility that the baby may be affected.
Use in Children
- Do not give Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid to newborn or premature babies.
- Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid must not be used in children under 6 years of age, due to the potential for fatal respiratory depression, psychiatric and CNS events.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid and affect how it works.
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid may increase the sedative effect of some medicines. These include:
- medicines used to treat depression, especially monoamine oxidase inhibitors and tricyclic antidepressants
- medicines used to help you sleep or relax (sedatives and hypnotics)
- opioid analgesics, medicines used to treat pain
- other antihistamines
- alcohol and alcohol containing medicines
- medicines for the treatment of irregular heartbeats (antiarrhythmics)
- medicines that help with your mood (antidepressants)
- medicines used to help with mental illness (antipsychotics)
- medicines to treat infections (antimicrobials)
- medicines used to treat nausea and vomiting like metoclopramide
- medicines used to relieve muscle spasm like carisoprodol and cyclobenzaprine
- medicines for the treatment of epilepsy or seizures
- medicines used to treat acid indigestion such as magnesium, aluminium and calcium salts, oxides and hydroxides
- medicines used to smooth muscle contractions in the gastrointestinal tract (antispasmodics)
These medicines may be affected by Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid.
4. How do I use Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
How much to take
- Follow the instructions provided with the medicine.
If you do not understand the instructions on the carton or the label, ask your pharmacist or doctor for help. - Follow all directions given to you by your pharmacist or doctor carefully.
They may differ from the information contained in this leaflet. - Use this drug only as recommended.
- Do not exceed the recommended dosage. There have been case reports of promethazine abuse.
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid are recommended for adults and children over 6 years of age. - It is recommended that the lowest effective dose of Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid be used in children 6 years of age or older.
Allergic Disorder
- Children 6-12 years: 10 to 25mL of the Oral Liquid as a single dose at night, or 10mL of the Oral Liquid, two to three times daily.
Sedation
- For short term use on the advice of a pharmacist or doctor.
- Children 6-12 years: 10 to 25mL of the Oral Liquid, as a single dose at night.
Travel Sickness
- Children 6-12 years: 10mL of the Oral Liquid.
- To be taken the night before travel and repeated after 6 to 8 hours on the following day if required.
Nausea and Vomiting
- Children 6-12 years: 10mL of the Oral Liquid, every 4 to 6 hours to a maximum daily dose of 20mL of the Oral Liquid.
Use in the Elderly
- If you are over 65 years of age, talk to you pharmacist or doctor about how much to take.
- Elderly patients are more likely to have side effects from taking these medicines.
How to take Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid
- Measure out the amount of Oral Liquid to be taken.
How long to take it
- Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid should not usually be taken for more than 10 days in a row. If your symptoms persist, see your pharmacist or doctor for advice.
If you forget to take it
If you are taking Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid for an allergic disorder and you forget to take your bedtime dose, you may need to take your dose in two or three smaller doses during the following day. Check with your pharmacist or doctor.
If you are taking Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid for travel sickness or nausea and vomiting, take your dose as soon as you remember.
If you are taking Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid for sedation, take your dose as soon as you remember. Be careful because you may still be affected in the morning.
Do not take a double dose to make up for the dose that you missed. This may be harmful.
If you are not sure what to do, ask your pharmacist or doctor.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you use too much Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid
If you think that you have used too much Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid, you may experience:
- over – excitement
- shaky and unsteady movements
- convulsions and/or tremors
- hallucinations
- difficulty breathing
- unconsciousness
- high fever
- heart palpitations, chest pain and/or rapid pulse
- dizziness
- nausea
- cold sweats
- memory and thinking problems; difficulty with learning new things, concentrating, or making decisions.
5. What should I know while using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid.
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid may cause your skin to be more sensitive to the sun. You should protect your skin from exposure to bright sunlight.
If you are about to be started on any new medicine, tell your pharmacist or doctor that you are taking Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.
If you become pregnant while you are taking this medicine, stop taking it and tell your doctor immediately.
Talk to your pharmacist or doctor if your symptoms do not improve.
Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.
Things you should not do
- Do not give Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid to anyone else, even if they have the same condition as you.
- Do not take Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid to treat any other complaints unless your pharmacist or doctor tells you to.
- Do not take more than the recommended dose unless your pharmacist or doctor tells you to.
Things to be careful of
- Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid is a known sedative and may cause drowsiness in some people.
- If you have a single dose at bedtime, you may still be affected in the morning.
- Children and the elderly are especially sensitive to the effects of antihistamines.
Neuroleptic malignant syndrome
A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stiffness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.
Driving or using machines
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 ml oral liquid can cause drowsiness, dizziness and blurred vision. Make sure you know how you react to Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid before you drive a car, operate machinery, or do anything else that could be dangerous if you experience drowsiness, dizziness and blurred vision. If this occurs do not drive or operate machinery.
Be careful before you drive or use any machines or tools until you know how Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid affects you.
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid may affect your ability to drive a car or operate machinery or do anything else that could be dangerous if you are drowsy, dizzy or experience blurred vision. If this occurs do not drive or operate machinery.
Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol.
Do not drink alcohol while taking Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid.
The sedation effects of alcohol may be increased.
Looking after your medicine
- Keep your medicine in the pack until it is time to take it.
- If you take your medicine out of the pack it will not keep as well.
- Store Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it, in a locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.
Less serious side effects
Less serious side effects | What to do |
General
| Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you. |
These are mild side effects of the medicine and are short-lived.
Serious/rare side effects
Serious side effects | What to do |
General
| Call your doctor straight away, if you notice any of these serious side effects. |
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
Very serious side effects | What to do |
Allergy related
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects |
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid contains
Active ingredient (main ingredient) |
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Other ingredients (inactive ingredients) |
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Do not take this medicine if you are allergic to any of these ingredients.
What Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid looks like
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid is clear, golden syrupy solution.
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid is available in a 100mL bottle.
Australian Registration Numbers
Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid: Aust R 426916
Who distributes Chemists' Own Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?
Arrotex Pharmaceutical Pty Ltd.
15–17 Chapel St
Cremorne VIC 3121
This leaflet was prepared in December 2024
Published by MIMS February 2025