Notuss-NXD

Name: Notuss-NXD

Manufacturer

  • SJ Pharmaceuticals, LLC

Notuss-NXD Drug Class

Notuss-NXD is part of the drug classes:

  • Piperazine derivatives

  • Opium alkaloids and derivatives

  • Sympathomimetics

What is the most important information I should know about Notuss-NXD (chlorcyclizine, codeine, and pseudoephedrine)?

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Ask a doctor before using this medicine to treat cold or flu symptoms in a child younger than 6 years old. Chlorcyclizine, codeine, and pseudoephedrine should not be used as a pain medicine in children younger than 12 or anyone under 18 who recently had surgery to remove the tonsils or adenoids.

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

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

You should not use this medicine if you are allergic to codeine, pseudoephedrine, or chlorcyclizine.

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 using this medicine to treat cold or flu symptoms in a child younger than 6 years old.

Chlorcyclizine, codeine, and pseudoephedrine should not be used as a pain medicine in children younger than 12 or 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:

  • asthma, COPD, bronchitis, or other breathing disorders;

  • a cough with mucus;

  • heart disease, high blood pressure;

  • glaucoma;

  • diabetes;

  • a thyroid disorder; or

  • enlarged prostate and urination problems.

If you use codeine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

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

How should I take Notuss-NXD (chlorcyclizine, codeine, and pseudoephedrine)?

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use chlorcyclizine, codeine, and pseudoephedrine 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.

Do not take for longer than 7 days in a row. Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

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

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

Keep track of your medicine. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Precautions While Using Notuss-NXD

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

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

  • Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual

For nursing mothers taking a codeine-containing medicine or any other narcotic cough medicine (dihydrocodeine, hydrocodone, or hydromorphone):

  • Call your doctor if you become extremely tired and have difficulty caring for your baby.
  • Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.
  • Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .

For patients taking antihistamine-containing medicine:

  • Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by the antihistamine in this medicine.
  • This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.
  • This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally.
  • 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 are not alert.
  • When taking antihistamines on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin at the same time (as in arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by the antihistamine.
  • Antihistamines may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

For patients taking decongestant-containing medicine:

  • This medicine may add to the central nervous system (CNS) stimulant effects of diet aids. Do not use medicines for diet or appetite control while taking this medicine unless you have checked with your doctor.
  • This medicine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.
  • Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking narcotic antitussive (codeine, dihydrocodeine, hydrocodone, or hydromorphone)-containing medicine:

  • This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.
  • This medicine may cause some people to become drowsy, dizzy, less alert than they are normally, or to feel a false sense of well-being. 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 are not alert and clearheaded.
  • Nausea or vomiting may occur after taking a narcotic antitussive. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your doctor.
  • Dizziness, lightheadedness, or fainting may be especially likely to occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.
  • Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking iodide (calcium iodide, iodinated glycerol, or potassium iodide)-containing medicine:

  • Make sure your doctor knows if you are planning to have any future thyroid tests. The results of the thyroid test may be affected by the iodine in this medicine.

For patients taking analgesic-containing medicine:

  • Check the label of all nonprescription (over-the-counter [OTC]), and prescription medicines you now take. If any contain acetaminophen or aspirin or other salicylates, including diflunisal or bismuth subsalicylate, be especially careful. Taking them while taking a cough/cold combination medicine that already contains them may lead to overdose. If you have any questions about this, check with your health care professional.
  • Do not take aspirin-containing medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

For diabetic patients taking aspirin- or sodium salicylate-containing medicine:

  • False urine sugar test results may occur:
    • If you take 8 or more 325-mg doses of aspirin every day for several days in a row.
    • If you take 8 or more 325-mg or 4 or more 500-mg doses of sodium salicylate.
  • Smaller doses or occasional use of aspirin or sodium salicylate usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

For patients taking homatropine-containing medicine:

  • This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Notuss-NXD Side Effects

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.

Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if: too much medicine is taken, it is taken in large doses, or it is taken for a long period of time.

Get emergency help immediately if any of the following symptoms of overdose occur:

For narcotic antitussive (codeine, dihydrocodeine, hydrocodone, or hydromorphone)-containing

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

  • Cold, clammy skin
  • confusion (severe)
  • convulsions (seizures)
  • drowsiness or dizziness (severe)
  • nervousness or restlessness (severe)
  • pinpoint pupils of eyes
  • slow heartbeat
  • slow or troubled breathing
  • Difficulty breathing
  • difficulty nursing
  • increased sleepiness (more than usual)
  • limpness
For acetaminophen-containing
  • Diarrhea
  • increased sweating
  • loss of appetite
  • nausea or vomiting
  • stomach cramps or pain
  • swelling or tenderness in the upper abdomen or stomach area
For salicylate-containing
  • Any loss of hearing
  • bloody urine
  • confusion
  • convulsions (seizures)
  • dizziness or lightheadedness
  • drowsiness (severe)
  • excitement or nervousness (severe)
  • fast or deep breathing
  • fever
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • increased sweating
  • nausea or vomiting (severe or continuing)
  • shortness of breath or troubled breathing (for salicylamide only)
  • stomach pain (severe or continuing)
  • uncontrollable flapping movements of the hands, especially in elderly patients
  • unusual thirst
  • vision problems
For decongestant-containing
  • Fast, pounding, or irregular heartbeat
  • headache (continuing and severe)
  • nausea or vomiting (severe)
  • nervousness or restlessness (severe)
  • shortness of breath or troubled breathing (severe or continuing)

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

For all combinations
  • Skin rash, hives, and/or itching
For antihistamine- or anticholinergic-containing
  • Clumsiness or unsteadiness
  • convulsions (seizures
  • drowsiness (severe)
  • dryness of mouth, nose, or throat (severe)
  • flushing or redness of face
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • restlessness (severe)
  • shortness of breath or troubled breathing
  • slow or fast heartbeat
For iodine-containing
  • Headache (continuing)
  • increased watering of mouth
  • loss of appetite
  • metallic taste
  • skin rash, hives, or redness
  • sore throat
  • swelling of face, lips, or eyelids
For acetaminophen-containing
  • Unexplained sore throat and fever
  • unusual tiredness or weakness
  • yellow eyes or skin

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:

  • Constipation
  • decreased sweating
  • difficult or painful urination
  • dizziness or lightheadedness
  • drowsiness
  • dryness of mouth, nose, or throat
  • false sense of well-being
  • increased sensitivity of skin to sun
  • nausea or vomiting
  • nightmares
  • stomach pain
  • thickening of mucus
  • trouble in sleeping
  • unusual excitement, nervousness, restlessness, or irritability
  • unusual tiredness or weakness

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.

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.

Product packaging

NOTUSS®-NXD

Antitussive - Decongestant - Antihistamine

Each 5 mL (one teaspoonful) for oral administration contains:
Codeine Phosphate .................................................. 10 mg
(WARNING: May be habit forming)
Pseudoephedrine HCl .............................................. 30 mg
Chlorcyclizine HCl ............................................... 9.375 mg

Rx Only

Sugar Free/Alcohol Free
Dye Free/Gluten Free

Berry Vanilla Flavor

16 fl. oz. (473 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant cap.

This bottle not to be dispensed to consumer.

Manufactured by:
Great Southern Laboratories
Houston, TX 77099

Distributed for:
SJ Pharmaceuticals
4200 Northside Parkway NW, Bldg. 12
Atlanta, GA 30327

Iss. 08/10
Notuss-NXD 
codeine phosphate, pseudoephedrine hcl, chlorcyclizine hcl liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24839-348
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Codeine Phosphate (Codeine) Codeine Phosphate 10 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
Chlorcyclizine Hydrochloride (Chlorcyclizine) Chlorcyclizine Hydrochloride 9.375 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Berry  
Vanilla  
Citric Acid  
Glycerin  
Propylene Glycol  
Water  
Sodium Citrate  
Saccharin Sodium  
Sorbitol  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:24839-348-16 473 mL in 1 BOTTLE
2 NDC:24839-348-10 10 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/03/2010
Labeler - SJ PHARMACEUTICALS, LLC (845662720)
Registrant - GREAT SOUTHERN LABORATORIES (056139553)
Establishment
Name Address ID/FEI Operations
GREAT SOUTHERN LABORATORIES 056139553 manufacture
Revised: 12/2011   SJ PHARMACEUTICALS, LLC
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