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.

GUAIFENESIN/PHENYLEPHRINE - ORAL

(gweye-FEN-eh-sin/fen-ill-EFF-rin)

COMMON BRAND NAME(S): Endal, Numonyl, Sinupan

USES: This combination medication is used to temporarily treat cough and runny/stuffy nose (nasal congestion) caused by infections (such as the common cold), allergies (such as hay fever), 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. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. Phenylephrine is a decongestant (sympathomimetic). It reduces nasal congestion by narrowing the blood vessels in the nose. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, 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 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).

HOW TO USE: Take this medication by mouth with or without food, as directed by your doctor. If you are self-treating, follow all directions on the product package. To prevent trouble sleeping, do not take this medication close to bedtime. If you have any questions, ask your doctor or pharmacist. Dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Guaifenesin may have a bitter taste. Swallow capsules and tablets whole. Scored tablets may be split for lower doses. Chewable tablets may be swallowed whole or chewed. Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/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. Tell your doctor if your condition is accompanied by fever, severe sore throat, rash, persistent headache, or if it persists, returns, or worsens after 7 days. These may be signs of a serious medical problem. Seek immediate medical attention if you think you may have a serious medical problem.

SIDE EFFECTS: Nausea or headache may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly. If your doctor has directed you to use this medication, remember that 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 any of these unlikely but serious side effects occur: dizziness, fainting, shaking (tremor), fast/irregular/pounding heartbeat, difficult/painful urination, mental/mood changes (such as confusion, nervousness, irritability), trouble sleeping, seizures. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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: Before taking this medication, tell your doctor or pharmacist if you are allergic to phenylephrine or guaifenesin; or if you have any other allergies. Also tell your doctor if you have had bad reactions to similar drugs (sympathomimetics such as ephedrine). 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: breathing problems (such as emphysema, chronic bronchitis, asthma, smoker's cough), cough with blood or large amounts of mucus, high blood pressure, heart disease (such as chest pain, heart failure, heart attack), fast/slow/irregular heartbeat, diabetes, a certain eye problem (glaucoma), difficulty urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism). This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Liquid forms of this product may contain sugar, aspartame, and/or alcohol. 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 product is not recommended in children younger than 6 years. Caution is advised when using this product in children because they may be more sensitive to its side effects, especially nervousness, irritability, and high blood pressure. (See also Uses Section.) Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, dizziness, problems urinating, trouble sleeping, or confusion. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Phenylephrine may pass into breast milk and could have undesirable effects on a nursing infant. It is unknown if guaifenesin passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: other decongestants (taken by mouth or sprayed into the nose), tricyclic antidepressants (such as nortriptyline, amitriptyline). Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, 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. Phenylephrine may decrease the effectiveness of some blood pressure medications (such as beta blockers, guanethidine, methyldopa, mecamylamine). Guaifenesin and phenylephrine are available in both prescription and nonprescription products. Check the labels of all your medications to make sure you are not taking more than one product containing guaifenesin or phenylephrine. Guaifenesin can affect the results of certain lab tests (such as urine levels of certain acids). Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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: severe dizziness/fainting, fast irregular heartbeat, slow/fast/shallow breathing, hallucinations, seizures.

NOTES: If your doctor prescribed this medication, do not share this medication with others. Keep all regular medical and laboratory appointments. This medication is 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.

MISSED DOSE: 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.

STORAGE: 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 for more details about how to safely discard your product.

Information last revised June 2020. Copyright(c) 2021 First Databank, Inc.