Guaifenesin; Pseudoephedrine Tablets or Capsules

Cold symptoms may include nasal congestion, but people may also have muscle and body aches or a cough they want to treat and there are specific medications that target these other symptoms like acetaminophen, ibuprofen, or dextromethorphan.

An FDA committee said 1 type of nasal decongestant doesn’t work, but experts say here’s what does

Experts say these tips can help fight off common cold symptoms this season.

September 27, 2023, 11:43 AM
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Over-the-counter agents to treat upper respiratory symptoms like nasal congestion make up a multi-billion-dollar business. But recently, an FDA advisory committee ruled that oral phenylephrine, commonly found in some over-the-counter, or OTC, products like Dayquil, Mucinex, and Sudafed PE, does not work as a decongestant.

The decision has left many consumers confused when searching for relief among all the available products on store shelves.

“It really is stressful for a lot of consumers,” board-certified pulmonary critical care and sleep medicine physician Dr. Raj Dasgupta, MD, chief medical advisor at Sleep Advisor, told ABC News.

The Food and Drug Administration said in a public statement that the product will stay on the market while they review the available evidence.

The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter-drugs, called the decision “disappointing” and offered to work with the FDA on the matter.

“We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status,” CHPA president and CEO Scott Melville said in the statement.

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Dasgupta says that taking oral phenylephrine isn’t dangerous and some people may believe it works for them, so those products don’t necessarily need to be thrown out due to a safety concern, but better options may be available.

For consumers buying new products, ABC News spoke to two experts to provide four tips to help find the right solution for sinus and cold symptoms this season.

Read the label, be intentional about purchase

Dasgupta explained that many people don’t actually know what products they are buying and that many products contain different medications that each treat different symptoms.

“If you are going to the store to pick up over the counter medications, you have to ask the question, ‘Why? Why are you going there,'” Dasgupta said.

Cold symptoms may include nasal congestion, but people may also have muscle and body aches or a cough they want to treat and there are specific medications that target these other symptoms like acetaminophen, ibuprofen, or dextromethorphan.

Greg Castelli, Pharm.D., director of academic and clinical pharmacy in the department of family medicine at the University of Pittsburgh School of Medicine, says that sometimes less is more and recommends that people buying new products should consider only buying the one indicated for their symptom.

“When you’re walking down those aisles, you’ll see that there are products that have three and four medications in combination with each other. And you just may not need to have all those individual medications,” Castelli said.

Pseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes used as a nasal/sinus decongestant, as a stimulant, or as a wakefulness-promoting agent.

STOCK PHOTO/Getty Images

Castelli says that oral pseudoephedrine can be found behind the pharmacy counter without a prescription and nasal sprays that contain phenylephrine are both effective agents for nasal congestion.

Certain medications that can be used to treat common cold symptoms such as diphenhydramine or Benadryl, a type of antihistamine, may also provide an added benefit of helping people fall asleep in addition to treating nasal inflammation, but should not be abused or overused.

Experts warn that all of these medications do have risks and side effects so people who have underlying medical problems should talk to their doctor about which one is right for them, or which ones should be avoided.

Some remedies don’t require medication to help

Experts say that rest, relaxation, and hydration are undervalued when combating colds, but they do help.

“I think that when you’re feeling sick, it’s always a good time to re-address some of those sleep hygiene things,” Dasgupta said.

Dasgupta recommends putting technology away before bed and making sure the room is cool and dark where you sleep at night, and if congestion is a problem, sleeping with the head of the bed elevated or on pillows can help.

Soup is good for the soul and sinuses

Experts say steam can help the sinuses, which can come from a hot shower or even from some comfort foods like chicken-noodle soup.

Guaifenesin; Pseudoephedrine Tablets or Capsules

Guaifenesin and pseudoephedrine come combined in some medications to treat cold and flu symptoms. Guaifenesin is an expectorant that helps break up mucus so you can get it out. Pseudoephedrine is a nasal decongestant that relieves a stuffy nose. A healthcare provider can tell you if this medication is right for you.

Overview

What is this medication?

GUAIFENESIN; PSEUDOEPHEDRINE (gwye FEN e sin; soo doe e FED rin) is a decongestant, expectorant combination. It is used to provide relief from cough and congestion. This medicine will not treat an infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Aldex GS, Altex-PSE, Ambi, Ambifed, Ambifed-G, Ami-Tex PSE, Aquatab D, Coldmist JR, Coldmist LA, Congestac, D Feda II, Decongest II, Deconsal II, Deconsal LA, Defen LA, Desal II, Drituss GP, Durasal II, Duratuss, Duratuss GP, Dynex, Entex PSE, Entex T, Eudal SR, ExeFen, ExeFen-IR, G Phed, G Phed PD, GP 500, Guai-Vent-PSE, Guaidrine GP, Guaidrine PSE, Guaifed PD, Guaifen PSE, Guaifenex GP, Guaifenex PSE-120, Guaifenex PSE-60, Guaifenex PSE-80, Guaifenex PSE-85, Guaimax D, Guaipax PSE, Guiatex II SR, Iosal II, Iotex PSE, Levall G, Maxifed, Maxifed-G, Medent-LD, Medent-LDI, Mintab D, Miraphen PSE, Mucinex D, Mucus-D, Nalex, Nalex JR, Nasatab LA, Nomuc-PE, PanMist JR, PanMist LA, Poly-Vent, Poly-Vent IR, Poly-Vent JR, Profen Forte, Profen II, Pseudatex, Pseudo GG TR, Pseudo Max, Pseudovent, Pseudovent-400, Pseudovent-PED, Respa 1st, Respaire SR, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robitussin Severe Congestion, Ru-Tuss DE, Ru-Tuss Jr., Sinutab, Stamoist E, Sudafed Non-Drying Sinus, Sudal SR, SudaTex-G, Touro LA, Touro LA-LD, V Dec M, Versacaps, WE Mist II LA, WE Mist LA, Zephrex

What should I tell my care team before I take this medication?

They need to know if you have any of the following conditions:

• Blood vessel disease.
• Diabetes.
• Fever.
• Glaucoma.
• Heart disease or heart rhythm problems.
• High blood pressure.
• Other chronic disease.
• Over active thyroid.
• Prostate trouble.
• An unusual or allergic reaction to guaifenesin, pseudoephedrine, other medicines, foods, dyes, or preservatives.
• Pregnant or trying to get pregnant.
• Breast-feeding.

How should I use this medication?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Do not crush or chew. Take your doses at regular times. Do not take more medicine than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

Patients over 60 years old may have a stronger reaction to this medicine and need smaller doses.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• Bromocriptine.
• Cocaine.
• Ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine.
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate.

This medicine may also interact with the following medications:

• Digoxin.
• Indomethacin.
• Mecamylamine.
• Medicines for blood pressure.
• Medicines for colds or allergies.
• Medicines for depression, anxiety, or psychotic disturbances.
• Medicines for sleep.
• Methyldopa.
• Reserpine.
• Some herbal or nutritional supplements.
• Some medicines for Parkinson’s disease.
• Stimulant medicines for attention disorders, weight loss, or to stay awake.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or health care professional if your symptoms do not improve within 5 days or if they get worse. If you have trouble falling asleep at night, take the last dose of the day at least a few hours before bedtime.

Drink water as instructed while you are taking this medicine to help loosen mucus.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue.
• Confusion.
• Difficulty passing urine.
• Fast or irregular heartbeat.
• Hallucinations.
• High blood pressure.
• Seizure.
• Tremor.
• Trouble breathing.

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• Anxiety, excitement, irritability, nervousness.
• Diarrhea.
• Dizziness.
• Headache.
• Loss of appetite.
• Stomach upset, nausea.

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from heat and moisture. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Additional Common Questions

What is Mucinex D?

Mucinex® D is a medication that relieves chest congestion and nasal congestion from infections like the common cold or flu. It temporarily eases your symptoms to help you feel better. But it doesn’t make the infection go away faster, and it doesn’t prevent you from spreading the infection to others.

Mucinex D has two active ingredients:

• Guaifenesin. This is an expectorant. It thins and loosens mucus in your airways so it can come up more easily. Getting this mucus out of your body can help relieve chest congestion.
• Pseudoephedrine. This is a nasal decongestant. It reduces swelling in your nasal cavities to help you breathe more easily through your nose.

Is Mucinex D available over the counter?

You can get Mucinex D without a prescription, but it’s what healthcare providers call a “behind-the-counter” medication. You’ll need to ask a store employee for it, and they’ll ask to see your photo ID. You don’t need to do this for Mucinex (without the D), which only contains guaifenesin.

You might be wondering, why do I have to ask for Mucinex D and show an ID to get it? It’s because it contains pseudoephedrine, which is an ingredient people have used to make methamphetamine (a type of amphetamine). Methamphetamine can be highly addictive, and misuse can lead to dangerous side effects.

U.S. law requires stores to keep all medications containing pseudoephedrine behind the counter, and people have to show a photo ID to purchase them. There are also limits on how much you can buy within a month. These policies are in place to help prevent people from misusing pseudoephedrine.

When should you take Mucinex D?

Follow your healthcare provider’s guidance on when to take Mucinex D and all other medications. In general, you may want to take Mucinex D or similar products when you have congestion in both your chest and your nose. It’ll help loosen mucus to get it out of your chest, and it’ll also help you breathe more easily through your nose.

You shouldn’t crush, break or chew the tablet. You need to swallow it whole. If you find it hard to swallow pills, your provider may recommend a liquid alternative.

Read the dosing instructions on the product label and ask your provider if there’s anything you don’t understand.

What is the difference between Mucinex D and DM?

Mucinex D and Mucinex DM both contain guaifenesin as an active ingredient. So, they’re both expectorants, or medications that help break up mucus to ease chest congestion. Expectorants help your cough become more productive (the cough brings up mucus so you can bid it farewell).

But their second active ingredient is where these medications differ. Mucinex D also contains pseudoephedrine, which relieves nasal congestion. Mucinex D is helpful if you have chest congestion plus a stuffy nose.

Mucinex DM doesn’t contain pseudoephedrine. Instead, it contains dextromethorphan, which is a cough suppressant. This means Mucinex DM will loosen your mucus while also calming your cough reflex. So, your cough will be productive (it’ll bring up mucus), but you won’t cough as often as you might without the medication.

You can get either medication without a prescription. But you’ll need to ask a store employee for Mucinex D and show your photo ID, since this medication is only sold behind the counter. You can buy Mucinex DM straight off the shelf.

Your healthcare provider can explain more about the differences between these and other medications. They’ll help you find the one that’s right for you based on your symptoms and medical history.

Does Mucinex D make you sleepy?

Drowsiness isn’t a typical side effect of Mucinex D. Tell your healthcare provider about any side effects you notice or any changes in your symptoms.

A note from Cleveland Clinic

Breaking up can be hard to do — especially when mucus insists on staying as long as possible. Medications that contain guaifenesin are designed to break up mucus so it can come up when you cough, rather than linger in your chest. This can ease chest congestion and help you feel better.

Medications that also contain pseudoephedrine — like those found in the cold medications aisle — ease nasal congestion, as well. These combined medications help relieve cold and flu symptoms so you can feel better during the day and sleep better at night. But before taking these or any other medications, talk to a healthcare provider first. They’ll make sure any medication is safe for you and appropriate for your symptoms.

Note: Intro and FAQ sections written and reviewed by Cleveland Clinic professionals.