OPIOID ANTITUSSIVE/ANTIHISTAMINE - ORAL

OPIOID ANTITUSSIVE/ANTIHISTAMINE - ORAL

PHONETIC PRONUNCIATION:

GENERIC NAME(S): chlorpheniramine maleate/codeine phosphate

Uses

USES: This combination product is used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). This product contains an opioid cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Do not use this product in children younger than 18 years. There is a risk of serious (rarely fatal) side effects, such as breathing problems. Cough-and-cold products do not cure colds. Cough due to a common cold often does not need to be treated with medicine. Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms, such as drinking enough fluids, using a humidifier, or saline nose drops/spray.


How to use OPIOID ANTITUSSIVE/ANTIHISTAMINE - ORAL

HOW TO USE: Read the Patient Information Leaflet or the Medication Guide if available from your pharmacist before you start taking this product 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 with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication may be taken with food or milk if stomach upset occurs. Do not take the sustained-release products more often than every 12 hours. If you are using the liquid form, use a medication measuring device or spoon to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose. If you are using the extended-release capsules, swallow them whole. Do not crush or chew extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. If you are using a sustained-release liquid that contains hydrocodone polistirex or codeine polistirex, do not mix the liquid with other liquids or medications. Doing so can destroy the long action of the drug and may increase side effects. Do not increase your dose or use this product more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (more than a few weeks) or in high doses. In such cases, withdrawal symptoms (such as anxiety, restlessness, sweating, shaking chills, nausea, vomiting, and 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 right away. Though it helps many people, this product has a risk for abuse and may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this product exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Inform your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.

Side Effects

SIDE EFFECTS: See also Warning section. Drowsiness, dizziness, headache, blurred vision, upset stomach, nausea, constipation, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To relieve dry mouth, suck on (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. 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 (e.g., hallucinations), ringing in the ears, trouble urinating, easy bruising/bleeding, fast/slow/irregular heartbeat. Get medical help right away if you have any very serious side effects, including: seizure. This product may cause serious mental/mood changes and very serious (rarely fatal) breathing problems. This product may contain codeine or dihydrocodeine. Codeine and dihydrocodeine are changed into strong opioid drugs (morphine or dihydromorphine) in your body. In some people this happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion. 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.

Precautions

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), gallbladder disease, adrenal gland problem (e.g., Addison's disease), certain brain disorders (e.g., head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema, sleep apnea), diabetes, a certain eye problem (glaucoma), heart problems, high blood pressure, kidney problems, liver disease, mental/mood problems (e.g., depression, psychosis), seizures, stomach/intestinal problems (e.g., ulcers, blockage), underactive thyroid (hypothyroidism), urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), obesity. This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine. This medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about the safe use of this product. Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing. 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. Also, using it for a long time or in high doses near the expected delivery date may harm 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 product may pass into breast milk. Consult your doctor before breastfeeding. Products that contain codeine or dihydrocodeine may have undesirable effects on a nursing infant, such as unusual sleepiness, difficulty feeding, trouble breathing, or unusual limpness. If your product contains codeine or dihydrocodeine, breast-feeding while using this product is not recommended.

Interactions

DRUG INTERACTIONS: 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 (e.g., benztropine, belladonna alkaloids), antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), cimetidine, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), naltrexone, scopolamine, tricyclic antidepressants (e.g., 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, hydrocodone), alcohol, marijuana, 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 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 this product from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole), bupropion, fluoxetine, macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), paroxetine, quinidine, rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others. This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: 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: confusion, cold/clammy skin, fast/slow/irregular heartbeat, slow/shallow breathing, seizures, coma.

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ECR, HP/CP 5/4

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TUSSICAPS 10 MG-8 MG CAPSULE

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ECR, HP/CP 10/8
TUSSICAPS 10 MG-8 MG CAPSULE

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ECR, HP/CP 10/8

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Faq for OPIOID ANTITUSSIVE/ANTIHISTAMINE - ORAL

A opioid antitussive/antihistamine is a medication that combines both an opioid (such as codeine or hydrocodone) and an antihistamine (such as chlorpheniramine or diphenhydramine) to relieve both cough and allergy symptoms.

The opioid component of the medication helps to suppress the cough reflex in the brain, while the antihistamine component helps to reduce symptoms of allergy, such as sneezing and runny nose.

These medications are typically used to treat cough and allergy symptoms associated with conditions like the common cold, flu, allergies, and sinusitis.

Yes, common side effects may include drowsiness, dizziness, constipation, dry mouth, and blurred vision. Additionally, the opioid component can be habit-forming if used in larger doses or for prolonged periods.

No, it is not recommended to drive or operate machinery while taking these medications, as they can cause drowsiness and impair your ability to perform these tasks safely.

These medications should be used with caution during pregnancy and breastfeeding, as they can pass into breast milk and potentially harm the baby. It is important to consult with a healthcare professional before using these medications in these situations.

Opioid antitussive/antihistamine medications have the potential to interact with other medications, including certain antidepressants, sedatives, and muscle relaxants. It is crucial to inform your healthcare provider about all the medications you are taking to avoid potential interactions.

These medications should be taken exactly as directed by your healthcare provider or as instructed on the packaging. It is important not to exceed the recommended dose or use them for a longer duration than recommended.

Yes, the opioid component in these medications can be habit-forming if used in larger doses or for prolonged periods. It is important to use them as directed and consult with a healthcare professional if you have concerns about addiction.


Warning

WARNING: Taking this product 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 this product 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.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.