Taking hydrocodone/chlorpheniramine with other medications that may also cause drowsiness or breathing problems may increase your risk of very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of hydrocodone/chlorpheniramine that works, and take it for the shortest possible time. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.Who should not take HYDROCODONE-CHLORPHENIRAMNE ER?
This combination product is used to treat coughs and other symptoms caused by the common cold or allergies. This product contains 2 medications: hydrocodone and chlorpheniramine. Hydrocodone is a narcotic cough suppressant (antitussive) that acts on a certain part of the brain (cough center) to reduce the urge to cough. Chlorpheniramine is an antihistamine that helps to relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.
Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. This product is not recommended for use in children younger than 6 years due to an increased risk of serious side effects (such as slow/shallow breathing). Ask your doctor or pharmacist for more details about using your product safely.
These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Giving more than the recommended dose or using this medication along with other cough-and-cold products has resulted in serious (even fatal) side effects, including slowed/stopped breathing. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). Do not use this product to make a child sleepy.
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking hydrocodone/chlorpheniramine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Read the Patient Information Leaflet if available from your pharmacist before you start taking hydrocodone/chlorpheniramine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually every 12 hours.
Shake this medication well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Do not mix this medication with other liquids or medications. Doing so can release all of the drug at once, increasing the risk of side effects.
The dosage is based on your age and response to treatment.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your condition persists or worsens.
See also Warning section.
To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, agitation, confusion, hallucinations), stomach/abdominal pain, difficulty urinating, fast/slow/irregular heartbeat.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this product, tell your doctor or pharmacist if you are allergic to hydrocodone or chlorpheniramine; or to dexchlorpheniramine; or to hydromorphone; or if you have any other allergies. This product may contain inactive ingredients (including sulfites such as sodium metabisulfite), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, croup, sleep apnea, chronic obstructive pulmonary disease-COPD), brain disorders (such as seizures, head injury, tumor), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), glaucoma (narrow-angle), difficulty urinating (such as due to enlarged prostate or urethral stricture), personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, gallbladder disease, underactive thyroid (hypothyroidism), adrenal gland problem (such as Addison's disease), disease of the pancreas (pancreatitis), mental/mood disorders (such as confusion, depression, thoughts of suicide, toxic psychosis), heart problems (such as irregular heartbeat).
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication may contain sugar. If you have diabetes, ask your doctor or pharmacist how to use this product safely.
Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.
Children may be more sensitive to the side effects of hydrocodone, especially slow/shallow breathing. Children may also be more sensitive to the effects of chlorpheniramine. In young children, antihistamines may cause agitation/excitement instead of drowsiness.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Using it during the last 3 months of pregnancy is not recommended because of possible harm to the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.
This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: anticholinergic drugs (such as benztropine, belladonna alkaloids, scopolamine), antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), narcotic antagonists (such as naloxone, naltrexone), certain pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol), tricyclic antidepressants (such as amitriptyline, desipramine).
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydromorphone), alcohol, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or other cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Other medications can affect the removal of hydrocodone/chlorpheniramine from your body, which may affect how hydrocodone/chlorpheniramine works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
Chlorpheniramine is very similar to dexchlorpheniramine. Do not use medications containing dexchlorpheniramine while using chlorpheniramine.
This product may interfere with certain laboratory tests (including allergy skin testing, amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, severe drowsiness/dizziness, mental/mood changes (such as confusion, agitation), cold/clammy skin, fast/slow/irregular heartbeat, seizures, coma.
If you are prescribed this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised January 2017. Copyright(c) 2017 First Databank, Inc.
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