Details for: DIMETANE EXPECTORANT DC
Company: FOUNDATION CONSUMER BRANDS, LLC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02244080 | DIMETANE EXPECTORANT DC | PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; GUAIFENESIN; HYDROCODONE BITARTRATE | 5 MG / 5 ML; 2 MG / 5 ML; 100 MG / 5 ML; 1.8 MG / 5 ML | SYRUP | ORAL |
Summary Reports
Summary Safety Review -Opioid-containing cough and cold products - Assessing the potential risk of opioid use disorder and related harms in children and adolescents
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Dimetane® Expectorant DC is used for the temporary relief, in adults, of coughs, runny nose, stuffy nose associated with:
- allergies, or
- the common cold
Dimetane® Expectorant DC is not for use in patients younger than 18 years of age. In patients this age, the risks of life-threatening breathing problems outweigh the benefits of treatment
What it does
Brompheniramine Maleate helps stop runny noses and sneezing
Phenylephrine Hydrochloride helps clears nasal congestion
Guaifenesin helps loosen phlegm
Codeine acts on the brain to supress cough.
When it should not be used
Do not use Dimetane® Expectorant DC if you:
- your doctor did not prescribe it for you
- are allergic to brompheniramine maleate, codeine phosphate, guaifenesin, phenylephrine hydrochloride or to any of the other ingredients in Dimetane® Expectorant DC
- have severe asthma, trouble breathing, or other breathing problems
- you have acute respiratory depression, elevated carbon dioxide levels in the blood and cor pulmonale
- have bowel blockage or narrowing of the stomach or intestines
- have a head injury
- are at risk for having seizures
- have diabetes
- have heart or thyroid problems
- have glaucoma
- suffer from alcoholism
- are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
- have been told by your doctor that you break down codeine rapidly. This can lead to codeine overdose even at the usual adult dose.
- are pregnant or planning to become pregnant or you are in labour
- are breastfeeding. The use of codeine-containing products while breast-feeding may harm your baby. If you breastfeed and take Dimetane® Expectorant DC, seek immediate medical care for your baby if they are overly drowsy, sedated, have difficulty breast-feeding, have breathing difficulties, and are floppy (have decreased muscle tone). This is very serious for the baby and can lead to death. Tell the baby’s doctor that you are breastfeeding and took Dimetane® Expectorant DC
What the medicinal ingredient is
Brompheniramine Maleate, Phenylephrine Hydrochloride, Guaifenesin and Hydrocodone Bitartrate
What the non-medicinal ingredients are
Alcohol, citric acid, cola flavour, D&C Red No. 33, FD&C Red No. 40, glycerin, invert sugar, menthol flavour, raspberry flavours, sodium benzoate and water.
What dosage form it comes in
Brompheniramine Maleate 2 mg, Phenylephrine Hydrochloride 5 mg, Guaifenesin 100 mg and Hydrocodone Bitartrate Syrup 1.8 mg: per 5mL of syrup
Warnings and precautions
Serious Warnings and Precautions
- Even if you take Dimetane® Expectorant DC as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
- You may get life threatening breathing problems while taking Dimetane Expectorant C. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
- You should never give anyone your Dimetane® Expectorant DC. They could die from taking it. If a person has not been prescribed Dimetane® Expectorant DC, taking even one dose can cause a fatal overdose. This is especially true for children.
- If you took Dimetane® Expectorant DC while you were pregnant, whether for short
or long periods of time or in small or large doses, your baby can suffer lifethreatening withdrawal symptoms after birth. This can occur in the days after
birth and for up to 4 weeks after delivery. If your baby has any of the following
symptoms:
- has changes in their breathing (such as weak, difficult or fast breathing)
- is unusually difficult to comfort
- has tremors (shakiness)
- has increased stools, sneezing, yawning, vomiting, or fever Seek immediate medical help for your baby.
- Taking Dimetane® Expectorant DC with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Dimetane® Expectorant DC. Talk about any health conditions or problems you may have, including if you:
- have a history of illicit or prescription drug or alcohol abuse
- have severe kidney, liver or lung disease
- have low blood pressure
- have past or current depression
- suffer from chronic or severe constipation
- have persistent or chronic cough (as occurs with smoking), high blood pressure
- have problems with your adrenal or prostate gland
- have, or had in the past hallucinations or other severe mental problems
- are under a physician’s care
Other warnings you should know about
Some people metabolize codeine at a much faster rate than the general population. This may lead to accidental overdose, especially in patients younger than 18 years of age. Stop taking Dimetane® Expectorant DC and seek immediate medical help if you start feeling confused, have shallow breathing, or extreme sleepiness. If you know that you metabolize codeine at a much faster rate, tell your doctor BEFORE starting this medication.
Stop taking Dimetane® Expectorant DC and consult with your healthcare professional if:
- you get a high fever, rash or persistent headache along with the cough.
- your symptoms or cough worsen or continue for more than 7 days.
These could be signs of a serious condition.
Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have any questions or concerns about abuse, addiction or physical dependence. As with all opioids, taking codeine may cause you to become dependent on it. Do not take more than the dose prescribed to you by your doctor.
Pregnancy, nursing, labour and delivery:
Do not use Dimetane® Expectorant DC while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. Dimetane® Expectorant DC can then cause life-threatening breathing problems in your unborn baby or nursing infant.
Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to Dimetane® Expectorant DC. Dimetane® Expectorant DC can cause:
- drowsiness
- dizziness or
- lightheadedness
This can usually occur after you take your first dose and when your dose is increased.
Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:
- nausea, vomiting
- feeling tired, weak or dizzy
- decreased appetite
You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off Dimetane® Expectorant DC.
Serotonin Syndrome: Codeine, one of the ingredients of Dimetane® Expectorant DC can cause Serotonin Syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take Dimetane® Expectorant DC with certain antidepressants or migraine medications.
Serotonin Syndrome symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
- fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness and coma.
Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with Dimetane® Expectorant DC
- Alcohol. This includes prescription and non-prescription medications that contain
alcohol. Do not drink alcohol while you are taking Dimetane® Expectorant DC. It can lead
to:
- drowsiness
- unusually slow or weak breathing
- serious side effects or
- a fatal overdose
- other sedative drugs which may enhance the drowsiness caused by Dimetane® Expectorant DC
- opioid analgesics (drugs used to treat pain)
- general anesthetics (drugs used during surgery)
- benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
- antidepressants (for depression and mood disorders). Do not take Dimetane® Expectorant DC with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.
- drugs used to treat serious mental or emotional disorders (such as schizophrenia)
- antihistamines (drugs used to treat allergies)
- antitussives
- decongestants
- expectorants
- anti-emetics (drugs used to prevent vomiting)
- drugs used to treat muscle spasms and back pain
- some anti-retroviral drugs (used to treat viral infections)
- some anti-fungal drugs (used to treat fungal infections)
- some antibiotic drugs (used to treat bacterial infections)
- some heart medication (such as beta blockers)
- tranquilizers, sedatives, sedating antihistamines, other depressants
- drugs used to treat migraines (eg. triptans)
- grapefruit juice
- St. John’s Wort
Proper use of this medication
- Your doctor will prescribe the lowest dose that works to control your symptoms.
- It is recommended that you only take Dimetane® Expectorant DC for up to 7 days. If you need to take Dimetane® Expectorant DC for longer, your doctor will determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose.
- Dimetane® Expectorant DC may be taken with or without food, with a glass of water.
Usual Dose
Adults:
Take 10 mL (2 tsps.) every 6 hours. Do not exceed 4 doses (8 tsps.) in a 24-hour period. .
Stopping your Medication
If you have been taking Dimetane® Expectorant DC for more than a few days, you should not stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking Dimetane® Expectorant DC. You should do it slowly to avoid uncomfortable symptoms such as having:
- body aches
- diarrhea
- goosebumps
- loss of appetite
- nausea
- feeling nervous or restless
- runny nose
- sneezing
- tremors or shivering
- stomach cramps
- rapid heart rate (tachycardia)
- having trouble sleeping
- an unusual increase in sweating
- heart palpitations
- an unexplained fever
- weakness
- yawning
By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking Dimetane® Expectorant DC.
Refilling your Prescription for Dimetane® Expectorant DC
A new written prescription is required from your doctor each time you need more Dimetane® Expectorant DC.
Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor
Overdose
If you think you have taken too much Dimetane® Expectorant DC, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Signs of overdose may include:
- unusually slow or weak breathing
- dizziness
- confusion
- extreme drowsiness
Missed Dose
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take two doses at the same time.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Dimetane® Expectorant DC. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Drowsiness
- Insomnia
- Dizziness
- Fainting
- Nausea, vomiting, or a poor appetite
- Dry mouth
- Headache
- Problems with vision
- Weakness, uncoordinated muscle movement
- Itching
- Sweating
- Constipation
- Low sex drive, impotence (erectile dysfunction), infertility
Talk with your doctor or pharmacist about ways to prevent constipation when you start using Dimetane® Expectorant DC.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| RARE: | |||
| Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone, cold and clammy skin | ✔ | ||
| Respiratory Depression: Slow, shallow or weak breathing | ✔ | ||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Bowel Blockage (impaction): abdominal pain, severe constipation, nausea | ✔ | ||
| Fast, Slow or Irregular Heartbeat: heart palpitations | ✔ | ||
| Low Blood Pressure: dizziness, fainting, lightheadedness | ✔ | ||
| Serotonin Syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor, diarrhea | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
- Keep Dimetane® Expectorant DC under lock, out of sight and reach of children and pets.
- Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes Dimetane® Expectorant DC, get emergency help right away.
- Store at room temperature (15-30ºC).
Disposal:
Dimetane® Expectorant DC should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about Dimetane® Expectorant DC:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug-product-database.html), or by calling Foundation Consumer Brands LLC. at 1-855-493-7065.
This leaflet was prepared by Foundation Consumer Brands LLC.
Last Revised: January 28, 2021