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. Therefore, this product is not recommended to treat cold symptoms in children younger than 6 years. 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.
Take this medication by mouth with or without food, usually every 12 hours or as directed by your doctor. Do not take this medication more often than every 12 hours. Doing so may increase the risk of serious (possibly fatal) breathing problems.
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.
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, sweating, uncontrolled movements, nausea, vomiting, diarrhea) 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 immediately.
When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. 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.
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 prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (such as stimulant-type with stool softener).
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.
Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, seizures.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.
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), certain brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), stomach/intestinal problems ( such as blockage, ileus, chronic constipation, Clostridium difficile-associated diarrhea), 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 (such as pancreatitis), mental/mood disorders (such as toxic psychosis), heart problems (such as irregular heartbeat), a certain spinal problem (kyphoscoliosis).
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.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
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 breathing problems. 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.
It is unknown if this drug passes into breast milk or may have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
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), cimetidine, naltrexone, 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 affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, certain antihistamines (such as diphenhydramine), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine, hydromorphone).
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.
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 overdose is suspected, contact a poison control center or emergency room immediately. 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.
Do not share this medication with others. It is against the law.
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.
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
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 for more details about how to safely discard your product.
Information last revised April 2014. Copyright(c) 2014 First Databank, Inc.
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