Respa-AR 8 mg-90 mg-0.24 mg tablet,extended release

Generic name:
Decongestant/antihistamine/anticholinergic - oral

This medication is used for the temporary relief of runny/stuffy nose, watery/itchy eyes, and itchy throat caused by allergies, hay fever, the common cold, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. The decongestant treats nasal congestion by narrowing the blood vessels in the nose. The antihistamine relieves itchy/watery eyes and itchy throat by blocking a substance (histamine) released by allergies. The anticholinergic dries up a runny nose and the fluid that runs down your throat causing itching/irritation.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 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. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the 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).

Take this medication by mouth with a full glass of water unless otherwise directed by your doctor. Carefully follow your doctor's directions for taking this medication. This medication may be taken with food or milk if stomach upset occurs. To prevent trouble sleeping, do not take this medication close to bedtime. If you have any questions, ask your doctor or pharmacist.

The dosage is based on the product you are taking and on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed.

If you are using a liquid form, carefully measure your prescribed dose using a medication-measuring device or spoon. 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.

Swallow extended-release capsules 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.

Chewable forms of this medication should be chewed thoroughly before swallowing.

Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking nonprescription products that contain caffeine.

Tell your doctor if your condition occurs with a headache that doesn't go away, fever, severe sore throat, rash, or if it lasts, returns, or gets worse after 7 days. These may be signs of a serious medical problem.

Drowsiness, dizziness, dry mouth, blurred vision, headache, stomach upset, and constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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:

• fast heartbeat
• mental/mood changes (such as nervousness, excitement, irritability)
• trouble sleeping
• shaking (tremors)
• difficult/painful urination

Get medical help right away if you have any very serious side effects, including:

• fainting
• very fast/pounding/irregular heartbeat
• severe mental/mood changes (such as confusion, hallucinations)
• seizures
• eye pain/swelling/redness
• vision changes (such as seeing rainbows around lights at night)

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 decongestant/antihistamine/anticholinergic combination medications, tell your doctor or pharmacist if you are allergic to any of the ingredients; or if you have any other allergies. Also tell your doctor if you have had a bad reaction to decongestants (such as ephedrine, phenylephrine, pseudoephedrine). 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:

• asthma
• high blood pressure
• heart disease (such as chest pain, heart failure, heart attack)
• fast/slow/irregular heartbeat
• diabetes
• personal or family history of glaucoma (angle-closure type)
• seizures
• stomach/intestinal ulcer
• kidney problems
• difficulty urinating (such as due to enlarged prostate, urinary retention)
• overactive thyroid (hyperthyroidism)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) 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 (cannabis).

Liquid and chewable forms of this product may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, dizziness, drowsiness, problems urinating, trouble sleeping, constipation, or confusion. Dizziness, drowsiness, trouble sleeping and confusion can increase the risk of falling.

Children may be more sensitive to the side effects of this drug, especially excitation, nervousness, or increased blood pressure.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Some ingredients in this product may pass into breast milk. Consult your doctor before breastfeeding.

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 drugs that may interact with this product are:

• antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray)
• digoxin
• potassium tablets/capsules
• pramlintide

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), 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.

Decongestants and antihistamines are available in both prescription and nonprescription products. Check the labels of all your medications carefully to make sure you are not taking more than one product containing these medications.

This medication may interfere with certain medical/lab tests (such as brain scan for Parkinson's disease, allergy skin test), possibly causing false test results. Make sure lab 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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: irregular heartbeat, vomiting, hallucinations, hot/dry skin, fainting, inability to wake up (coma), seizures.

Do not share this medication with others.

This medication is usually for temporary use only. Do not take this medication for more than 7 days unless your doctor tells you to do so. Tell your doctor if your condition lasts longer than 7 days.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications 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.

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.