Brand Name
US Brand Name
Cotab A
Cotab AX
EndaCof-C
Zodryl AC 25
Zodryl AC 30
Zodryl AC 35
Zodryl AC 40
Zodryl AC 50
Zodryl AC 60
Zodryl AC 80
Z-Tuss AC
Description
Codeine and chlorpheniramine combination is used to relieve cough and respiratory symptoms associated with a cold or allergy.
Codeine is a narcotic cough suppressant. It acts directly on the cough center in the brain to prevent a cough. Chlorpheniramine is an antihistamine that treats or prevents the symptoms of an allergy.
When codeine is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics or barbiturates are used for this purpose. Physical dependence may lead to withdrawal side effects when you suddenly stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Extended Release
- Solution
Before Using
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
Appropriate studies have not been performed on the relationship of age to the effects of codeine and chlorpheniramine combination in the pediatric population. It should not be used in children younger than 12 years of age. Safety and efficacy have not been established.
This medicine should not be used to relieve pain after surgery removal of tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of codeine and chlorpheniramine combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
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.
- Isocarboxazid
- Linezolid
- Mavorixafor
- Methylene Blue
- Moclobemide
- Naltrexone
- Ozanimod
- Phenelzine
- Potassium Citrate
- Procarbazine
- Rasagiline
- Safinamide
- Samidorphan
- 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.
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acepromazine
- Aclidinium
- Adagrasib
- Alfentanil
- Almotriptan
- Alosetron
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
Other Interactions
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.
- Grapefruit Juice
Using this medicine with any of the following may cause an increased risk of certain side effects 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
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:
- Adrenal gland problem or
- Alcohol or drug use disorder or dependence, or history of or
- Brain tumor or
- Breathing or lung problems (eg, COPD, hypercapnia, hypoxia) or
- Cor pulmonale (serious heart condition) or
- Enlarged prostate or
- Head injury or
- Increased pressure in the head or
- Trouble urinating—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Lung or breathing problems (eg, respiratory depression) or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
- Diabetes or
- Pancreatitis (swelling of the pancreas) or
- Seizures—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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 and cause mental or physical dependence.
This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
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 (extended-release tablets):
- For cough and symptoms of allergies and cold:
- Adults—One tablet every 12 hours as needed. Do not take more than 2 tablets in 24 hours.
- Children 12 years of age and older—Use and dose must be determined by your doctor.
- Children younger than 12 years of age—Use is not recommended.
- For cough and symptoms of allergies and cold:
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.
Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm .
Precautions
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 cough does not improve or if it gets worse within 5 days, call your doctor.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
If you are especially sensitive to the effects of this medicine, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: change or loss of consciousness, cold, clammy skin, constricted pupils, difficulty or trouble breathing, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or sleepiness or drowsiness.
Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine".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". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:
- Children younger than 12 years of age.
- Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
- Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).
If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects.
For nursing mothers taking this medicine:
- Talk to your doctor if you have any questions about taking codeine or about how this medicine may affect your baby.
- Call your doctor if you become extremely tired and have difficulty caring for your baby.
- Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
- Check with your doctor or hospital emergency room right away 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.
This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
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. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.
Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a cough, dizziness, fast heartbeat, hives, rash, itching, puffiness or swelling of the eyelids, or around the eyes, face, lips, or tongue, tightness in the chest, trouble breathing or swallowing, or unusual tiredness or weakness while you are using this medicine.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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.
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.
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.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Agitation
- anxiety
- black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- blurred vision
- change or loss of consciousness
- chest pain or tightness
- chills
- cold sweats
- coma
- confusion
- constipation
- cool, pale skin
- cough
- darkened urine
- darkening of the skin
- decrease blood pressure
- diarrhea
- difficulty or trouble breathing
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- falling
- fast, pounding, or irregular heartbeat or pulse
- feeling of constant movement of self or surroundings
- fever
- headache, sudden and throbbing
- hives, itching, skin rash
- increased blood pressure
- increased hunger
- indigestion
- irregular, fast or slow, shallow breathing
- loss of appetite
- lower back or side pain
- mental depression
- nausea
- nervousness
- nightmares
- overactive reflexes
- painful or difficult urination
- pains in stomach, side, or abdomen, possibly radiating to the back
- pale or blue lips, fingernails, or skin
- pinpoint red spots on the skin
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- restlessness
- seeing, hearing, or feeling things that are not there
- seizures
- sensation of spinning
- shakiness and unsteady walk
- shakiness in the legs, arms, hands, or feet
- shivering
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach cramps or pain
- sweating
- swollen or painful glands
- talking or acting with excitement you cannot control
- tingling of the hands or feet
- trouble getting pregnant
- trouble sleeping
- twitching
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- chest pain
- cold, clammy skin
- confusion
- coughing that sometimes produces a pink frothy sputum
- difficulty or trouble breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- increased sweating
- irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- sweating
- swelling in the legs and ankles
- unusual tiredness or weakness
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:
Incidence not known
- Body aches or pain
- constricted, pinpoint, or small pupils
- cough producing mucus
- decrease in frequency of urination
- decrease in urine volume
- difficulty in moving
- difficulty in passing urine (dribbling)
- double vision
- ear congestion
- frequent urge to urinate
- halos around lights
- heartburn
- indigestion
- joint pain
- loss of voice
- muscle pain or stiffness
- night blindness
- overbright appearance of lights
- seeing double
- stuffy or runny nose
- thickening of bronchial secretions
- tunnel vision
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
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.
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