Notuss-NX

Name: Notuss-NX

What should I discuss with my healthcare provider before taking Notuss-NX (chlorcyclizine and codeine)?

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Ask a doctor before giving this medicine to a child younger than 12 years old.

Medicines that contain codeine should not be used in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

To make sure this medicine is safe for you, tell your doctor if you have:

  • any type of breathing problem (asthma, COPD);

  • glaucoma;

  • enlarged prostate, urination problems;

  • cough with mucus, or cough caused by emphysema or chronic bronchitis;

  • heart disease, high blood pressure; or

  • a thyroid disorder.

Using chlorcyclizine and codeine during pregnancy could harm the unborn baby. Ask a doctor before using this medicine if you are pregnant.

Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby. Do not breast-feed. Chlorcyclizine may slow breast milk production.

How should I take Notuss-NX (chlorcyclizine and codeine)?

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use chlorcyclizine and codeine in larger amounts, or for longer than prescribed. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

You should not use antihistamine medication to make a child sleepy.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold medicine within the past few days.

Store at room temperature away from moisture and heat. Do not freeze.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What should I avoid while taking Notuss-NX (chlorcyclizine and codeine)?

Avoid drinking alcohol.

Ask a doctor or pharmacist before using any other cold, allergy, cough, or sleep medicine. Many combination medicines contain antihistamines or decongestants. Taking certain products together can cause you to get too much of a certain drug.

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Notuss-NX (chlorcyclizine and codeine) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Stop using this medicine and call your doctor at once if you have:

  • severe dizziness, restless feeling, or nervousness;

  • little or no urinating; or

  • severe stomach cramps or constipation.

Common side effects may include:

  • drowsiness;

  • mild constipation; or

  • feeling restless or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses For Notuss-NX

Cough/cold combinations are used mainly to relieve the cough due to colds, influenza, or hay fever. They are not to be used for the chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (pronounced flem) with the cough.

Cough/cold combination products contain more than one ingredient. For example, some products may contain an antihistamine, a decongestant, and an analgesic, in addition to a medicine for coughing. If you are treating yourself, it is important to select a product that is best for your symptoms. Also, in general, it is best to buy a product that includes only those medicines you really need. If you have questions about which product to buy, check with your pharmacist.

Since different products contain ingredients that will have different precautions and side effects, it is important that you know the ingredients of the medicine you are taking. The different kinds of ingredients that may be found in cough/cold combinations include:

Antihistamines—Antihistamines are used to relieve or prevent the symptoms of hay fever and other types of allergy. They also help relieve some symptoms of the common cold, such as sneezing and runny nose. They work by preventing the effects of a substance called histamine, which is produced by the body. Some examples of antihistamines contained in these combinations are:

  • Bromodiphenhydramine
  • Brompheniramine
  • Carbinoxamine
  • Chlorpheniramine
  • Dexchlorpheniramine
  • Diphenhydramine
  • Doxylamine
  • Phenindamine
  • Pheniramine
  • Phenyltoloxamine
  • Pyrilamine
  • Promethazine
  • Triprolidine

Decongestants—Decongestants produce a narrowing of blood vessels. This leads to clearing of nasal congestion. However, this effect may also increase blood pressure in patients who have high blood pressure. These include:

  • Ephedrine
  • Phenylephrine
  • Pseudoephedrine

Antitussives—Antitussives help relieve coughing and are some contain a narcotic. These antitussives act directly on the cough center in the brain. Narcotics may become habit-forming, causing mental or physical dependence, if used for a long time. Physical dependence may lead to withdrawal side effects when you stop taking the medicine.

    Narcotic antitussives
  • Codeine
  • Dihydrocodeine
  • Hydrocodone
  • Hydromorphone
    Non-narcotic antitussives
  • Carbetapentane
  • Caramiphen
  • Dextromethorphan

Expectorants—Expectorants work by loosening the mucus or phlegm in the lungs. The main expectorant used in cough and cold medicines is guaifenesin. Other ingredients added as expectorants (for example, ammonium chloride, calcium iodide, iodinated glycerol, ipecac, potassium guaiacolsulfonate, potassium iodide, and sodium citrate) have not been proven to be effective. In general, the best thing you can do to loosen mucus or phlegm is to drink plenty of water.

Analgesics—Analgesics are used in these combination medicines to help relieve the aches and pain that may occur with the common cold. These include:

  • Acetaminophen
  • Aspirin
  • Other salicylates such as salicylamide and sodium salicylate

The use of too much acetaminophen and salicylates at the same time may cause kidney damage or cancer of the kidney or urinary bladder. This may occur if large amounts of both medicines are taken together for a long time. However, taking the recommended amounts of combination medicines that contain both acetaminophen and a salicylate for short periods of time has not been shown to cause these unwanted effects.

Anticholinergics—Anticholinergics, such as homatropine may help produce a drying effect in the nose and chest.

These cough and cold combinations are available both over-the-counter (OTC) and with your doctor's 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 .

Proper Use of cough and cold combinations

This section provides information on the proper use of a number of products that contain cough and cold combinations. It may not be specific to Notuss-NX. Please read with care.

To help loosen mucus or phlegm in the lungs, drink a glass of water after each dose of this medicine, unless otherwise directed by your doctor.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

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 .

For patients taking the extended-release capsule or tablet form of this medicine:

  • Swallow the capsule or tablet whole.
  • Do not crush, break, or chew before swallowing.
  • If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.

For patients taking the extended-release oral solution or oral suspension form of this medicine:

  • Do not dilute with fluids or mix with other drugs.

For patients taking a combination medicine containing an antihistamine and/or aspirin or other salicylate:

  • Take with food or a glass of water or milk to lessen stomach irritation, if necessary.

If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it. This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.

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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Keep the liquid form of this medicine from freezing. Do not refrigerate the syrup.

Warnings

Do not exceed recommended dosage.

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • may cause or aggravate constipation
Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  These could be signs of a serious condition.
  • new symptoms occur
If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Directions


Adults and children 12 years of age and older:
2 teaspoonfuls (10 mL) every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour period.

Children under 12 years of age:
Consult a doctor

Do not exceed recommended dosage.

For the Consumer

Applies to chlorcyclizine / codeine: oral liquid

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Stop using this medicine and call your doctor at once if you have:

  • severe dizziness, restless feeling, or nervousness;

  • little or no urinating; or

  • severe stomach cramps or constipation.

Common side effects may include:

  • drowsiness;

  • mild constipation; or

  • feeling restless or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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