Consumer medicine information

Benadryl Original Oral Liquid

Diphenhydramine hydrochloride + Ammonium chloride

BRAND INFORMATION

Brand name

Benadryl Original Oral Liquid

Active ingredient

Diphenhydramine hydrochloride + Ammonium chloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Benadryl Original Oral Liquid.

BENADRYL Original

BENADRYL Original

Active ingredient(s): Diphenhydramine hydrochloride and Ammonium chloride

 Consumer Medicine Information (CMI)

This leaflet provides important information about using BENADRYL Original. 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 BENADRYL Original.

Where to find information in this leaflet:

1. Why am I using BENADRYL Original?
2. What should I know before I use BENADRYL Original?
3. What if I am taking other medicines?
4. How do I use BENADRYL Original?
5. What should I know while using BENADRYL Original?
6. Are there any side effects?
7. Product details

 1. Why am I using BENADRYL Original?

BENADRYL Original contains the active ingredients Diphenhydramine hydrochloride and Ammonium chloride. Diphenhydramine hydrochloride belongs to a group of medicines called antihistamines. It works by reducing common cold symptoms, such as runny nose, sneezing and watery eyes. It also helps suppress dry, raspy coughs by its action in the brain. Ammonium chloride is an expectorant.

BENADRYL Original is used to relieve the symptoms of dry raspy coughs due to a cold.

 2. What should I know before I use BENADRYL Original?

Warnings

Do not use BENADRYL Original if:

  • you are allergic to Diphenhydramine hydrochloride or other antihistamines, Ammonium chloride, 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 or breath, wheezing or difficulty breathing, swelling of the face, lips tongue or other parts of the body, rash, itching or hives on the skin
  • you are younger than 6 years
  • you are having an asthma attack
  • have narrow-angle glaucoma
  • have duodenal or stomach ulcers or other stomach problems
  • have prostate problems
  • have bladder problems
  • have severe liver failure
  • have severe renal impairment
  • have taken other products containing sedating antihistamines.

Check with your doctor or pharmacist:

  • before using in children 6 years and over
  • if you have any other medical conditions
    - breathing problems such as emphysema or chronic bronchitis
    - chronic obstructive airways disease
    - pneumonia
    - asthma
    - persistent or chronic coughs or coughs that produce a lot of mucus
    - liver or kidney disease
    - epilepsy
    - glaucoma.
  • if you take sedatives
  • if you take any medicines for any other condition
  • if you have allergies to any other medicines, foods, preservatives or dyes.

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 pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are breastfeeding.

 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 BENADRYL Original and affect how it works.

These include

  • medicines used to treat depression such as monoamine oxidase inhibitors (especially if taken within the last 14 days) and tricyclic antidepressants
  • medicines used to help you relax, sleep or relieve anxiety, such as tranquillizers, sedatives and hypnotics
  • medicines with strong anticholinergic effects such as some travel sickness medicines, medicines to relieve stomach cramps or spasms, and medicines used in Parkinson's disease
  • opioid analgesics used to treat pain
  • alcohol
  • betablockers (metoprolol), medicines used to treat high blood pressure, heart conditions and prevent migraines.

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 BENADRYL Original.

 4. How do I use BENADRYL Original?

How much to take

  • The recommended dose of BENADRYL Original for children 6 years to 12 years is 5mL every 4 hours as necessary. The recommended dose for adults and children over 12 years is every 4 hours as necessary
  • Follow the instructions provided with the medicine.
  • Do not exceed 6 doses in 24 hours.
  • Do not exceed the recommended dosage.
  • If you are over 65 years of age, talk to your pharmacist or doctor about how much to take.

When to take BENADRYL Original

  • BENADRYL Original should be used every 4 hours as necessary.

How to take BENADRYL Original

  • Measure the recommended dose in a medicine measure and swallow.
  • Follow all directions given to you by your pharmacist or doctor carefully. This may differ from the information contained in this leaflet.
  • If you forget to take it and it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, you may take a dose as soon as you remember if you think you need it. Do not take a double dose to make up for the dose that you missed.
  • If you do not understand the instructions on the pack, ask your pharmacist or doctor for help.

If you use too much BENADRYL Original

If you think that you have used too much BENADRYL Original, 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.

 5. What should I know while using BENADRYL Original?

Things you should do

Stop use an talk to your doctor or pharmacist if your symptoms persist, worsen, or if new symptoms occur. Your doctor or pharmacist will assess your condition and decide if you should continue to take the medicine.

Remind any doctor, dentist or pharmacist you visit that you are using BENADRYL Original.

Things you should not do

  • Do not take BENADRYL Original to treat any other complaints unless your pharmacist or doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not take more than the recommended dose unless your pharmacist or doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how BENADRYL Original affects you.

BENADRYL Original may cause dizziness in some people.

If this happens, do not drive or operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Do not take alcohol while using BENADRYL Original. The sedative effects of alcohol may be increased.

Looking after your medicine

  • Keep your medicine in the original pack until it is time to take.
  • Keep your medicine in a cool dry place where the temperature stays below 30°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.

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 effectsWhat to do
  • fatigue
  • drowsiness
  • weakness
  • dizziness
  • nausea, vomiting or stomach discomfort
  • constipation
  • diarrhoea
  • increased appetite
  • thicker phlegm
  • dry mouth, nose, throat or eyes
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • blurred vision
  • sensitivity to light
  • ringing in the ears
  • headache
  • fast heart beat
  • palpitations
  • low blood pressure
  • tightness of chest or throat
  • tingling or numbness of the hands and feet
  • difficulty in passing urine
  • confusion
  • excitation
  • insomnia
  • nervousness, anxiety or irritability
  • impaired performance (such as with work or driving)
  • psychosis (a mental disorder)
  • hallucinations
  • muscle spams
  • movement disorders, lack of coordination
  • tremor
  • seizures (fits)
  • hives
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.

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. Children and people over 65 years if age may have an increased chance of getting side effects.

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 BENADRYL Original contains

Active ingredient
(main ingredient)		Diphenhydramine hydrochloride
Ammonium chloride
Other ingredients
(inactive ingredients)		Sucrose
Glucose-liquid
Glycerol
Sodium citrate
Raspberry flavour
Citric acid monohydrate
Saccharin sodium
Menthol
Allura Red FC
Brilliant Blue FCF
Sodium benzoate

Do not take this medicine if you are allergic to any of these ingredients.

What BENADRYL Original looks like

BENADRYL Original is a clear slightly opalescent dark red liquid with raspberry flavour. (Aust R 199371).

Who distributes BENADRYL Original

Johnson & Johnson Pacific
45 Jones Street
Ultimo NSW 2007
Australia
Phone: 1800 029979

This leaflet was prepared in Dec 2023.

Published by MIMS February 2024

BRAND INFORMATION

Brand name

Benadryl Original Oral Liquid

Active ingredient

Diphenhydramine hydrochloride + Ammonium chloride

Schedule

S3

 

1 Name of Medicine

Diphenhydramine hydrochloride, ammonium chloride.

2 Qualitative and Quantitative Composition

Each 5 mL of Benadryl Original contains diphenhydramine hydrochloride 12.5 mg and ammonium chloride 125 mg.
Benadryl contains benzoates, saccharin, sugars and sodium (33.8 mg/10 mL). See Section 6.1 for the full list of excipients.

3 Pharmaceutical Form

Benadryl Original is a clear to slightly opalescent red liquid with a raspberry flavour.

4 Clinical Particulars

4.1 Therapeutic Indications

Benadryl Original provides relief from the symptoms of coughs and nasal congestion due to common cold.

4.2 Dose and Method of Administration

The recommended doses of Benadryl Original are:
6 to 12 years: 5 mL.
Adults and children over 12 years: 10 mL.
The recommended dose should be taken every 4 hours as required. Do not exceed 6 doses in 24 hours.
Benadryl Original should not be used for children under 6 years, and should be used under the advice of a doctor for children 6-11 years.

4.3 Contraindications

1. Known hypersensitivity or idiosyncratic reaction to diphenhydramine (or substances of similar chemical structure) or any of the other ingredients in the product.
2. Narrow angle glaucoma.
3. Stenosing peptic ulcer.
4. Symptomatic prostatic hypertrophy.
5. Bladder neck obstruction.
6. Pyloroduodenal obstruction.
7. Severe liver failure or renal impairment.
8. Children under the age of 6 years (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
9. Patients taking monoamine oxidase inhibitors (MAOIs) (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

Patients with the following conditions should be advised to consult a physician before using Benadryl Original:
breathing problems such as emphysema or chronic bronchitis;
persistent or chronic cough such as with smoking, asthma or emphysema;
cough accompanied by excessive secretions (mucus);
glaucoma;
prostate hyperplasia with urinary retention.
Patients should not use with any other products containing diphenhydramine, even ones used on skin. If symptoms persist, worsen, or if new symptoms appear, stop use and consult a physician.

Concomitant treatment.

Precaution is recommended if other sedating antihistamines are taken concomitantly.

Mental alertness.

Diphenhydramine may cause drowsiness and may increase the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery. Alcohol should be avoided (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Diphenhydramine may enhance the sedative effects of central nervous system depressants including sedatives and tranquilizers. Consult a healthcare professional prior to taking with central nervous system depressants.

Hepatic impairment.

Benadryl Original should be used with caution in patients with hepatic impairment.

Epilepsy.

Benadryl Original should be used with caution in patients with epilepsy impairment.

Renal impairment.

Benadryl Original should be used with caution in patients with renal impairment.

Use in the elderly.

No data available.

Paediatric use.

Diphenhydramine may cause excitability, especially in children. Benadryl Original should not be used for children under 6 years of age and should be used under the advice of a doctor for children 6-11 years.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Diphenhydramine possesses anticholinergic activity which may be potentiated by other drugs with strong anticholinergic effects such as MAOIs and tricyclic antidepressants (TCAs), resulting in increased anticholinergic adverse effects.
Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics.
Diphenhydramine may potentiate the effects of certain beta-blockers such as metoprolol due to inhibition of CYP2D6 mediated metabolism.

4.6 Fertility, Pregnancy and Lactation

(Category A)
Diphenhydramine and ammonium chloride are both Pregnancy Category A. There are no adequate and well-controlled studies for the combination of ammonium chloride and diphenhydramine (with or without menthol and sodium citrate) in pregnant or breast-feeding women. This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus. A physician should be consulted before use if pregnant.
 Diphenhydramine is excreted in breast milk. Therefore, Benadryl Original is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant. A physician should be consulted before breastfeeding.

Effects on fertility.

No data available.

4.7 Effects on Ability to Drive and Use Machines

Due to diphenhydramine's potential for sedation, caution should be used when driving a motor vehicle or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

The following rare side effects have been associated with diphenhydramine hydrochloride use.

Body as a whole.

Headache, photosensitivity, asthenia.

Cardiovascular system.

Hypotension, palpitations, tachycardia.

Digestive system.

Constipation, diarrhoea, dry mouth, dry throat, dyspepsia, nausea, vomiting.

Nervous system.

Agitation/ excitation, anxiety, confusion, convulsions, disturbed coordination, dizziness, hallucinations, insomnia, irritability, nervousness, paresthesia, somnolence/ sedation, tremor. Impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills and impaired information processing), appetite stimulation, muscle dyskinesias and activation of epileptogenic foci.

Respiratory system.

Dryness of nose, thickening of bronchial secretions, tightness of chest or throat, wheezing.

Skin.

Pruritus, rash, urticaria.

Special senses.

Dryness of the eyes, blurred vision, tinnitus.

Urogenital system.

Urinary hesitancy and retention.
Somnolence was the most frequently reported adverse effect.
Nausea and vomiting have been reported with high doses of ammonium chloride.

Postmarketing data.

Adverse drug reactions (ADRs) identified during postmarketing experience with the combination of ammonium chloride and diphenhydramine (with or without menthol and sodium citrate) are included in Table 1. The frequencies are provided according to the following convention: very common ≥ 1/10; common ≥ 1/100 and < 1/10; uncommon ≥ 1/1,000 and < 1/100; rare ≥ 1/10,000 and < 1/1,000; very rare < 1/10,000; not known (cannot be estimated from the available data).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at: https://www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
Keep out of reach of children. In the event of an overdose, seek medical attention immediately.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

As an antihistamine, diphenhydramine hydrochloride antagonizes endogenous histamine by competitively and reversibly blocking the histamine H1 receptor.
As an antitussive, diphenhydramine hydrochloride selectively suppresses the central cough mechanism, thus raising the threshold for afferent (incoming) cough pulses.
Ammonium chloride is an expectorant that has an irritant effect on mucous membranes.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Diphenhydramine hydrochloride is well absorbed from the gastrointestinal tract, although high first-pass metabolism appears to affect systemic bioavailability. Following a single 50 mg oral dose, peak plasma concentrations of 66 ± 22 nanogram/mL were achieved in 2.3 ± 0.64 hours. Bioavailability of the oral form is reported to be 72 ± 26%.
Ammonium chloride is absorbed from the gastrointestinal tract. The ammonium ion is converted into urea in the liver or is attached to the amide nitrogen of glutamine for transport in the blood.

Distribution.

Diphenhydramine hydrochloride is widely distributed throughout the body, including the central nervous system (CNS). It crosses the placenta and has been detected in breast milk. Diphenhydramine is highly bound to plasma proteins and total protein binding is reported to be 78 ± 3%. Volume of distribution is 4.5 ± 2.8 L/kg.

Metabolism.

Metabolism is extensive with approximately 50% of diphenhydramine hydrochloride metabolized in the liver to the inactive metabolite diphenylmethane, which suggests a large first-pass effect.

Excretion.

Little, if any, diphenhydramine hydrochloride is excreted unchanged in the urine. The elimination half-life of diphenhydramine hydrochloride is 8.5 ± 3.2 hours and may be prolonged with age. Total body clearance is 6.2 ± 1.7 mL/min-1/kg-1 and may be decreased with age.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benadryl Original contains sucrose, glucose-liquid, glycerol, sodium citrate, raspberry flavour, citric acid monohydrate, saccharin sodium, menthol, Allura Red FC, Brilliant Blue FCF, sodium benzoate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Benadryl Original is available in a glass bottle containing 200 mL.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Chemical Name: 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride.

CAS number.

Diphenhydramine hydrochloride: 58-73-1.
Ammonium chloride: 1215-02-9.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Summary Table of Changes