Dexalone (Oral)

Dextromethorphan is used to help relieve coughs caused by colds or influenza (flu). It should not be used for chronic coughs that happen with smoking, asthma, or emphysema, or when there is a large amount of mucus or phlegm with the cough.

Dextromethorphan works by acting directly on the cough center in the brain to relieve coughing.

This medicine is available without a prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

If your cough has not improved after 7 days, if your sore throat has not improved after 2 days, if you have a high fever, a skin rash, or a headache that keeps coming back with the cough, or if you have asthma or high blood pressure, check with your doctor. These signs may mean that you have other medical problems.

Dissolve lozenges in your mouth carefully to reduce the risk of choking.

In deciding to use a medicine, you need to consider the risks versus the benefits. This is a decision you will make with your doctor. For this medicine, the following should be taken into account:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of dextromethorphan in children to other age groups, but this medicine is not expected to cause different side effects or problems in children 4 years of age and older compared to adults.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children may cause serious or possibly life-threatening side effects.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known whether they work the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of dextromethorphan in elderly patients to other age groups.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

While some medicines should not be mixed at all, in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be needed. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Moclobemide
• Nialamide
• Ozanimod
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Toloxatone
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Adagrasib
• Alfentanil
• Almotriptan
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Benzhydrocodone
• Benzphetamine
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Carbamazepine
• Chlorpheniramine
• Citalopram
• Clomipramine
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dextroamphetamine
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Ethylmorphine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Gepirone
• Givosiran
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Imipramine
• Ketobemidone
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Memantine
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methylene Blue
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Palonosetron
• Panobinostat
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Protriptyline
• Remifentanil
• Rizatriptan
• Rolapitant
• Sertraline
• Sibutramine
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Tianeptine
• Tilidine
• Tocilizumab
• Tramadol
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or frequency for one or both medicines.

• Abiraterone Acetate
• Haloperidol
• Quinidine
• Terbinafine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical conditions, especially:

• Asthma—Since dextromethorphan reduces coughing, it may make it harder to clear mucus from the lungs and airways during asthma.

• Diabetes (sugar diabetes)—Some products may contain sugar and can affect blood glucose control.

• Liver disease—Dextromethorphan may build up in the body and cause unwanted effects.

• Chronic bronchitis or
• Emphysema or
• Mucus or phlegm with cough—Since dextromethorphan reduces coughing, it may make it harder to clear mucus that collects in the lungs and airways with some diseases.

• Slowed breathing—Dextromethorphan may further slow your breathing rate.

Along with its intended effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Contact your doctor as soon as possible if any of the following side effects occur:

Symptoms of overdose

• Blurred vision
• confusion
• difficulty in urination
• drowsiness or dizziness
• nausea or vomiting (severe)
• shakiness and unsteady walk
• slowed breathing
• unusual excitement, nervousness, restlessness, or irritability (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away as your body gets used to the medicine. Your health care professional may also know ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common or rare

• Confusion
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• nausea or vomiting
• stomach pain

Other side effects not listed may also happen in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Babee Cof Syrup
• Benylin Pediatric Formula
• Children's Pedia Care
• Creomulsion
• Creo-Terpin
• Delsym
• Dexalone
• ElixSure Cough Children's
• Father John's Medicine
• Miltuss
• Nycoff
• Pediacare
• Pediacare Long-Acting Cough
• Robafen Cough
• Robitussin
• Silphen DM
• Simply Cough
• St. Joseph
• Vicks 44 Cough Relief

Available Dosage Forms:

• Suspension, Extended Release
• Solution
• Tablet
• Liquid
• Capsule, Liquid Filled
• Elixir
• Syrup

Therapeutic Class: Antitussive

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient, and many liquid medicines contain alcohol.

Use this medicine only as directed by your doctor or the directions on the label. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor or the label says. Although this effect has happened only rarely, dextromethorphan has become habit-forming (causing mental or physical dependence) in some persons who used too much for a long time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For lozenge dosage form: For cough: Adults and children 12 years of age and older—5 to 15 mg every two to four hours, as needed. Children 6 to 12 years of age—5 to 15 mg every two to six hours, as needed. Children 4 to 6 years of age—5 mg every four hours, as needed. Children and infants up to 4 years of age—Use is not recommended.
• For syrup dosage form: For cough: Adults and children 12 years of age and older—30 mg every six to eight hours, as needed. Children 6 to 12 years of age—7 mg every four hours or 15 mg every six to eight hours, as needed. Children 4 to 6 years of age—3.5 mg every four hours or 7.5 mg every six to eight hours, as needed. Children and infants up to 4 years of age—Use is not recommended.
• For extended-release oral suspension dosage form: For cough: Adults and children 12 years of age and older—60 mg every twelve hours, as needed. Children 6 to 12 years of age—30 mg every twelve hours, as needed. Children 4 to 6 years of age—15 mg every twelve hours, as needed. Children and infants up to 4 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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