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BENADRYL® Original Oral Liquid

(New Formula) hydrochloride, Ammonium chloride

Consumer Medicine Information

What is in this leaflet Ask your pharmacist or doctor if · duodenal or stomach ulcers or you have any questions about this other stomach problems This leaflet answers some common medicine. · prostate problems questions about BENADRYL Your pharmacist or doctor may have · bladder problems Original Oral Liquid. It does not given it for another reason. contain all the available information. · severe liver failure It does not take the place of talking to · severe renal impairment your pharmacist or doctor. Do not give this medicine to babies All medicines have risks and Before you take or children under six years of age. benefits. Your pharmacist or doctor BENADRYL Original Do not take this medicine after the has weighed the risks of you taking expiry date (EXP) printed on the BENADRYL Original against the When you must not take it pack or if the packaging is torn or benefits they expect it will have for shows signs of tampering. you. Do not take BENADRYL Original if you have an to: If it has expired or is damaged, return If you have any concerns about · any medicine containing it to your pharmacist for disposal. taking this medicine, ask your diphenhydramine or other If you are not sure whether you pharmacist or doctor. should start taking this medicine, Keep this leaflet with the medicine. · any medicine containing talk to your pharmacist or doctor. You may need to read it again. ammonium chloride Before you start to take it · any of the ingredients listed at the end of this leaflet. Tell your pharmacist or doctor if you have to any other Some of the symptoms of an allergic What BENADRYL medicines, foods, preservatives or reaction may include: Original is used for dyes. · shortness of breath Tell your pharmacist or doctor if BENADRYL Original is used to · wheezing or difficulty breathing you have or have had any of the relieve the symptoms of dry raspy following medical conditions: coughs due to a cold. · swelling of the face, lips, tongue or other parts of the body · breathing problems such as BENADRYL Original contains emphysema or chronic bronchitis medicines called diphenhydramine · rash, itching or on the skin. and ammonium chloride. Do not take this medicine if you · chronic obstructive airways disease Diphenhydramine belongs to a group are also taking monoamine oxidase of medicines called ©antihistamines©. inhibitors, a type of medicine used · pneumonia to treat depression. Diphenhydramine helps to reduce · asthma symptoms, such as Do not take this medicine if you · persistent or chronic coughs or runny nose, sneezing and watery have had any of the following coughs that produce a lot of eyes. Diphenhydramine also helps medical conditions: mucus suppress dry, raspy coughs by its · narrow-angle glaucoma action in the brain. Ammonium · kidney or liver disease chloride is an expectorant. · epilepsy

BENADRYL® ORIGINAL ORAL LIQUID (NEW FORMULA) 1 · glaucoma. medicines to relieve stomach Elderly patients are more likely to Ask your pharmacist or doctor cramps or spasms, and medicines have side effects from taking these before using in children 6 years used in Parkinson©s disease medicines. and over. · opioid used to treat How to take it Do not use this medicine if you are pain having an asthma attack. · Measure the recommended dose in a medicine measure and swallow. Do not take with other sedating · betablockers (metoprolol), antihistamines. medicines used to treat high When to take it Tell your pharmacist or doctor if blood pressure, heart conditions you take . and prevent migraines. Take the recommended dose every 4 hours, as required. Tell your pharmacist or doctor if These medicines may be affected by you are pregnant or plan to BENADRYL Original or may affect Do not exceed 6 doses in 24 hours. become pregnant. how well it works. You may need different amounts of your medicines, If you forget to take it Your pharmacist or doctor will or you may need to take different If it is almost time for your next discuss the benefits and possible medicines. risks of taking the medicine during dose, skip the dose you missed and pregnancy. Your pharmacist and doctor will take your next dose when you are have more information on medicines meant to. Ask your pharmacist or doctor to be careful with or avoid while Otherwise, you may take a dose as about taking this medicine if you taking this medicine. are breastfeeding. soon as you remember if you think you need it. Your pharmacist or doctor will discuss the benefits and possible Do not take a double dose to make risks of taking the medicine if you How to take up for the dose that you missed. are breastfeeding. BENADRYL Original This may increase the chance of you If you have not told your getting an unwanted side effect. pharmacist or doctor about any of Follow all directions given to you Your next dose should be taken in the above, tell him/her before you by your pharmacist or doctor 4 hours if you think you need it. start taking BENADRYL Original. carefully. If you are not sure what to do, ask They may differ from the your pharmacist or doctor. Taking other medicines information contained in this leaflet. Tell your pharmacist or doctor if If you do not understand the If you take too much you are taking any other instructions on the box/bottle, ask (overdose) medicines, including any that you your pharmacist or doctor for Immediately telephone your doctor get without a prescription from help. or the Poisons Information Centre your pharmacy, supermarket or (in , call 13 11 26) for health food shop. How much to take advice or go to Accident and Some medicines and BENADRYL The recommended doses of Emergency at the nearest hospital, Original may interfere with each BENADRYL Original are: if you think that you or anyone else other. · 6 to 12 years: 5 mL may have taken too much These include: BENADRYL Original. Do this · Over 12 years: 10 mL · medicines used to treat even if there are no signs of Do not use BENADRYL Original depression such as monoamine discomfort or poisoning. for children under 6 years. oxidase inhibitors (especially if taken within the last 14 days) and Ask your pharmacist or doctor before tricyclic using in children 6 years and over. While you are using · medicines used to help you relax, Do not take more than the sleep or relieve anxiety, such as recommended dose. BENADRYL Original tranquillizers, sedatives and If you are over 65 years of age, talk hypnotics to your pharmacist or doctor about Things you must do · medicines with strong how much to take. Stop use and talk to your effects such as pharmacist or doctor if your some travel sickness medicines,

BENADRYL® ORIGINAL ORAL LIQUID (NEW FORMULA) 2 symptoms do not improve, worsen, Ask your pharmacist or doctor to · tremor or if new symptoms appear. answer any questions you may · seizures (fits) have. Your pharmacist or doctor will assess · hives your condition and decide if you Tell your pharmacist or doctor if The above list includes serious side should continue to take the medicine. you notice any of the following and effects that may require medical they worry you: attention. These side effects are rare. Things you must not do · drowsiness If any of the following happen, tell Do not drink alcohol while taking · fatigue your doctor immediately or go to BENADRYL Original. · weakness Accident and Emergency at your The effects of alcohol may · dizziness nearest hospital: be increased. · nausea, vomiting or stomach · severe nausea and vomiting Do not take BENADRYL Original discomfort · shortness of breath, wheezing or to treat any other complaints difficulty breathing unless your pharmacist or doctor · tells you to. · diarrhoea · swelling of the face, lips, tongue or other parts of the body Do not give your medicine to · increased appetite · skin rashes or itching. anyone else, even if they have the · thicker phlegm same condition as you. The above list includes very serious · dry mouth, nose or throat or eyes. Do not take more than the side effects. You may need urgent recommended dose unless your The above list includes the more medical attention or hospitalisation. pharmacist or doctor tells you to. common side effects of your These side effects are very rare. medicine. They are usually mild. Tell your pharmacist or doctor if Things to be careful of Tell your doctor as soon as possible you notice anything that is making if you notice any of the following: Be careful driving or operating you feel unwell. machinery until you know how the · blurred vision Other side effects not listed above medicine affects you. · sensitivity to light may also occur in some people. This medicine may cause dizziness · ringing in the ears or drowsiness in some people. · Drowsiness may continue the following day. If this happens, do not · fast heart beat After using drive or operate machinery. · palpitations BENADRYL Original · low blood pressure Storage · tightness of chest or throat Keep your medicine in the original · tingling or numbness of the hands Side effects pack until it is time to take. and feet Keep your medicine in a cool dry Tell your pharmacist or doctor as · difficulty in passing urine soon as possible if you do not feel place where the temperature stays · confusion well while you are taking below 30°C. BENADRYL Original. · excitation Do not store BENADRYL Original This medicine helps most people · or any other medicine in the with dry coughs and cold symptoms, · nervousness, anxiety or bathroom or near a sink. Do not but it may have unwanted side effects irritability leave it on a window sill or in the in a few people. All medicines can car. · restlessness, agitation have side effects. Sometimes they are Heat and dampness can destroy some serious, most of the time they are not. · impaired performance (such as medicines. You may need medical attention if with work or driving) Keep your medicine where you get some of the side effects. · psychosis (a mental disorder) children cannot it. Do not be alarmed by the following · hallucinations A locked cupboard at least one-and- lists of side effects. You may not · muscle spasms a-half metres above the ground is a experience any of them. · movement disorders, lack of good place to store medicines. coordination

BENADRYL® ORIGINAL ORAL LIQUID (NEW FORMULA) 3 Disposal Ask your pharmacist what to do BENADRYL is a registered with any medicine that is left over, trademark. or if the expiry date has passed. AUST R 199371

Product description This leaflet was prepared in February 2020. What it looks like BENADRYL Original is a clear or slightly opalescent dark red liquid with raspberry flavour. It is available in bottles of 100mL and 200mL.

Ingredients Each 5 mL of BENADRYL Original contains 12.5 mg of diphenhydramine hydrochloride and 125 mg of ammonium chloride as the active ingredients. It also contains the following inactive ingredients: · sucrose · glucose-liquid · glycerol · sodium citrate dihydrate · raspberry flavour · citric acid monohydrate · saccharin sodium · menthol · Allura Red FC · Brilliant Blue FCF · sodium benzoate

This medicine contains 135.2mg/ 40mL (maximum daily dose) of sodium. This medicine does not contain lactose, gluten or tartrazine.

Sponsor BENADRYL Original is made in Australia from local and imported components, and sponsored by: Johnson & Johnson Pacific 45 Jones Street Ultimo NSW 2007 Australia

BENADRYL® ORIGINAL ORAL LIQUID (NEW FORMULA) 4