ElixSure Cough Children's (Oral)

Dextromethorphan is used to 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 cough.

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 may cause serious or possibly life-threatening side effects.

If your cough does not get better after 7 days, if your sore throat does not improve after 2 days, if you have a high fever, skin rash, or a persistent headache along with the cough, or if you have asthma or high blood pressure, contact your doctor. These symptoms may indicate other health issues.

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

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medications. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter 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 it is not expected to cause different side effects or problems in children 4 years of age and older than in 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 can lead to serious or possibly life-threatening side effects.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Some medicines should not be taken together, while others may be used together even if an interaction might occur. In these cases, your doctor may need to adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are chosen based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or may 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 how often you take one or both of the 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 may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Haloperidol
• Quinidine
• Terbinafine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are chosen based on their potential significance and are not necessarily a complete list.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to inform your doctor about any other medical problems you have, especially:

• Asthma—Dextromethorphan decreases coughing, making it harder to clear mucus from the lungs and airways during asthma.

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

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

• Chronic bronchitis or
• Emphysema or
• Mucus or phlegm with cough—Dextromethorphan decreases coughing, making it harder to clear mucus that may build up in the lungs and airways with these conditions.

• Slowed breathing—Dextromethorphan may further slow breathing rates.

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

Check with 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you how to prevent or lessen 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, check with 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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