Notuss-Forte

In the U.S.

• Hydron PSC
• Hyphed
• Notuss-Forte
• Zutripro

In Canada

• Vasofrinic Dh

Available Dosage Forms:

• Liquid
• Tablet
• Suspension
• Solution
• Syrup
• Capsule

Therapeutic Class: Antitussive, Opioid/Antihistamine/Decongestant Combination

Pharmacologic Class: Chlorpheniramine

Chemical Class: Hydrocodone

Hydrocodone, chlorpheniramine, and pseudoephedrine combination is used to relieve cough and nasal congestion associated with the common cold and upper respiratory allergies.

Hydrocodone is a narcotic antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve cough. Chlorpheniramine is an antihistamine, which is used to relieve or prevent symptoms of an allergy. Pseudoephedrine is a decongestant, which decreases nasal congestion by narrowing the blood vessels and reducing blood flow to the nasal passage.

When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing cough and nasal congestion should not let the fear of dependence keep them from using narcotics to relieve their cough. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Use of Zutripro® is not indicated in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Zutripro® in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Dihydroergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nalmefene
• Naltrexone
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amineptine
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Anileridine
• Aprepitant
• Aripiprazole
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzphetamine
• Boceprevir
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clorazepate
• Clozapine
• Cocaine
• Codeine
• Conivaptan
• Cyclobenzaprine
• Dasabuvir
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Eletriptan
• Enflurane
• Erythromycin
• Escitalopram
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosaprepitant
• Fospropofol
• Frovatriptan
• Furazolidone
• Granisetron
• Guanethidine
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iobenguane I 123
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methyldopa
• Methylene Blue
• Midazolam
• Midodrine
• Milnacipran
• Mirtazapine
• Moclobemide
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nialamide
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ombitasvir
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Palonosetron
• Papaveretum
• Paregoric
• Paritaprevir
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Piperacetazine
• Pipotiazine
• Piritramide
• Posaconazole
• Prazepam
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Rasagiline
• Remifentanil
• Remoxipride
• Ritonavir
• Rizatriptan
• Saquinavir
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or
• Asthma or
• Diabetes or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Head injury, history of or
• Problems with passing urine or
• Thyroid disease—Use with caution. May increase risk for more serious side effects.

• Heart disease (eg, coronary artery disease), severe or
• Hypertension (high blood pressure), severe or
• Narrow angle glaucoma or
• Urinary retention—Should not be used in patients with these conditions.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Lung or breathing problems (eg, respiratory depression) or
• Stomach or bowel problems (eg, paralytic ileus)—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain hydrocodone, chlorpheniramine, and pseudoephedrine. It may not be specific to Notuss-Forte. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Measure the oral liquid correctly using the marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Ask your pharmacist for instructions for measuring the correct dose of this medicine.

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 oral dosage form (solution):
  • For relief of cough, sneezing, or runny or stuffy nose:
    • Adults—5 milliliters (mL) every 4 to 6 hours as needed. However, the dose is usually not more than 4 doses (20 mL) in 24 hours.
    • Children—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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If your symptoms do not improve or if they get worse, call your doctor.

Do not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

Symptoms of an overdose include: extreme dizziness or weakness, trouble breathing, slow heartbeat or breathing, seizures, and cold, clammy skin. In case of an overdose, call your doctor right away.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, fever, high-pitched cry, irritability, shakiness or tremor, vomiting, weight loss, or failure to gain weight.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Fainting
• lightheadedness
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Abdominal or stomach cramps or pain
• bloating
• blurred vision
• bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• confusion
• constipation
• convulsions
• decrease in the frequency of urination
• decrease in the urine volume
• diarrhea
• difficult or troubled breathing
• difficulty in passing urine (dribbling)
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fainting
• fast, slow, or irregular heartbeat
• headache
• irregular, fast or slow, or shallow breathing
• loss of appetite
• nervousness
• painful urination
• pale or blue lips, fingernails, or skin
• pounding in the ears
• shortness of breath
• sore throat
• spasm of the throat
• sweating
• tightness of the chest
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Disturbed color perception
• double vision
• dry mouth
• false or unusual sense of well-being
• fear or nervousness
• halos around lights
• hyperventilation
• nausea
• night blindness
• overbright appearance of lights
• relaxed and calm
• restlessness
• sleepiness or unusual drowsiness
• sleeplessness
• trouble sleeping
• tunnel vision
• unable to sleep
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Acid or sour stomach
• belching
• bigger, dilated, or enlarged pupils (black part of the eye)
• bloating
• change in color vision
• chills
• cold sweats
• coma
• continuing ringing or buzzing or other unexplained noise in the ears
• cool, pale skin
• darkened urine
• depression
• difficulty seeing at night
• feeling of constant movement of self or surroundings
• fever
• flushing or redness of the skin
• full feeling
• hearing loss
• heartburn
• hives or welts
• increased appetite
• increased hunger
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• increased sensitivity of the eyes to sunlight
• increased sweating
• indigestion
• itching skin
• loss of appetite
• nightmares
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pressure in the stomach
• seizures
• sensation of spinning
• skin rash
• slurred speech
• stomach discomfort or upset
• sugar in the urine
• swelling of the abdominal or stomach area
• swelling of the breasts or breast soreness in both females and males
• unusually warm skin
• watering of the eyes
• yellow eyes or skin

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

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

Applies to chlorpheniramine / hydrocodone / pseudoephedrine: oral capsule, oral liquid, oral solution, oral suspension, oral syrup, oral tablet

Along with its needed effects, chlorpheniramine / hydrocodone / pseudoephedrine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking chlorpheniramine / hydrocodone / pseudoephedrine:

• Fainting
• lightheadedness
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Abdominal or stomach cramps or pain
• bloating
• blurred vision
• bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• confusion
• constipation
• convulsions
• decrease in the frequency of urination
• decrease in the urine volume
• diarrhea
• difficult or troubled breathing
• difficulty in passing urine (dribbling)
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fainting
• fast, slow, or irregular heartbeat
• headache
• irregular, fast or slow, or shallow breathing
• loss of appetite
• nervousness
• painful urination
• pale or blue lips, fingernails, or skin
• pounding in the ears
• shortness of breath
• sore throat
• spasm of the throat
• sweating
• tightness of the chest
• unusual tiredness or weakness
• vomiting

Some side effects of chlorpheniramine / hydrocodone / pseudoephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Disturbed color perception
• double vision
• dry mouth
• false or unusual sense of well-being
• fear or nervousness
• halos around lights
• hyperventilation
• nausea
• night blindness
• overbright appearance of lights
• relaxed and calm
• restlessness
• sleepiness or unusual drowsiness
• sleeplessness
• trouble sleeping
• tunnel vision
• unable to sleep
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Acid or sour stomach
• belching
• bigger, dilated, or enlarged pupils (black part of the eye)
• bloating
• change in color vision
• chills
• cold sweats
• coma
• continuing ringing or buzzing or other unexplained noise in the ears
• cool, pale skin
• darkened urine
• depression
• difficulty seeing at night
• feeling of constant movement of self or surroundings
• fever
• flushing or redness of the skin
• full feeling
• hearing loss
• heartburn
• hives or welts
• increased appetite
• increased hunger
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• increased sensitivity of the eyes to sunlight
• increased sweating
• indigestion
• itching skin
• loss of appetite
• nightmares
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pressure in the stomach
• seizures
• sensation of spinning
• skin rash
• slurred speech
• stomach discomfort or upset
• sugar in the urine
• swelling of the abdominal or stomach area
• swelling of the breasts or breast soreness in both females and males
• unusually warm skin
• watering of the eyes
• yellow eyes or skin

Applies to chlorpheniramine / hydrocodone / pseudoephedrine: oral capsule, oral liquid, oral suspension extended release, oral syrup, oral tablet

General

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Some side effects of Notuss-Forte may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.