Guaifenesin 

(gwye fen' e sin)

IMPORTANT WARNING:

FDA Intends to Remove Some Unapproved Cough, Cold, and Allergy Drugs from the Market

This safety alert does not apply to this medication, but only to some products which contain this medication. In addition, it is important that you know that there is not a problem with most of the products described in this medication monograph. And some drug companies may decide to seek full approval from the FDA so that they can continue marketing their products.

On March 2, 2011, the Food and Drug Administration (FDA) issued a safety alert about certain unapproved prescription cough, cold, and allergy products containing this drug in combination with other drugs. These products are not currently approved by the FDA for safety, effectiveness, and quality. FDA asked drug companies to stop shipping most of these products for sale in the US within the next 6 months. Although some of these products have been marketed for many years, laws about what a company must prove to FDA for drug product approval have gotten tougher and increased enforcement of these laws is now taking place. The FDA took this action due to concerns about certain potential risks associated with use of these medications. These risks may include:

  • the possibility of improper use in infants and young children
  • potentially risky combinations of ingredients
  • patients receiving too much or too little of the medication because of problems with the way some ''timed-release'' products are made

If you are concerned that the prescription cough, cold, and allergy medication you are taking is not approved by the FDA, you should talk to your doctor or pharmacist. If the medication you are taking is not approved, your doctor can prescribe another prescription medication or your doctor or pharmacist can suggest an over-the-counter (OTC) cough, cold, and allergy product for your condition. There are many safe and effective alternative approved products that can be taken instead. Your doctor probably prescribed the medicine without knowing that FDA had not approved it. This is because it has been so difficult for doctors and pharmacists to find out that these products are unapproved. For additional information:

  • You can visit the FDA website (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm244852.htm ) for more information about this action to remove unapproved cough, cold, and allergy products from the market.
  • You can find a list of unapproved products by going to (http://goo.gl/Gqc7d ).
  • For information on how to dispose of unused products, go to http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm .

WHY is this medicine prescribed?

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

HOW should this medicine be used?

Guaifenesin comes as a tablet, a capsule, an extended-release (long-acting) tablet, dissolving granules, and a syrup (liquid) to take by mouth. The tablets, capsules, dissolving granules, and syrup are usually taken with or without food every 4 hours as needed. The extended-release tablet is usually taken with or without food every 12 hours. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take guaifenesin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Guaifenesin comes alone and in combination with antihistamines, cough suppressants, and decongestants. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.

Nonprescription cough and cold combination products, including products that contain guaifenesin, can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4 to 11 years of age, use caution and follow the package directions carefully.

If you are giving guaifenesin or a combination product that contains guaifenesin to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give guaifenesin products that are made for adults to children.

Before you give a guaifenesin product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child's age on the chart. Ask the child's doctor if you don't know how much medication to give the child.

If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.

Swallow the extended-release tablets whole with a full glass of water. Do not break, crush, or chew them.

If you are taking the dissolving granules, empty the entire contents of the packet onto your tongue and swallow.

If your symptoms do not improve within 7 days or if you also have a high fever, a rash, or a headache that does not go away, call your doctor.

Are there OTHER USES for this medicine?

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking guaifenesin,

  • tell your doctor and pharmacist if you are allergic to guaifenesin, any other medications, or any of the ingredients in the guaifenesin product you plan to take. Check the package label for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
  • tell your doctor if you smoke and if you have or have ever had a cough that occurs with a large amount of phlegm (mucus) or if you have or have ever had a breathing problem such as asthma, emphysema, or chronic bronchitis. If you will be taking the dissolving granules, tell your doctor if you are on a low magnesium diet or if you have kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking guaifenesin, call your doctor.
  • if you have phenylketonuria (PKU, a inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the dissolving granules may be sweetened with aspartame, a source of phenylalanine.

What SPECIAL DIETARY instructions should I follow?

Drink plenty of fluids while you are taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Guaifenesin is usually taken as needed. If your doctor has told you to take guaifenesin regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Guaifenesin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache

• nausea

  • vomiting

Guaifenesin may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about guaifenesin.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand Names
  • Adult Tussin®
  • Air Power®
  • Bronchoril®
  • Chest Congestion®
  • Childrens Mucinex®
  • Childrens Mucus Relief®
  • Cough Out®
  • Diabetic Siltussin DAS-Na®
  • Diabetic Tussin Expectorant®
  • Diabetic Tussin Mucus Relief®
  • Equaline Tussin®
  • Equate Tussin®
  • Good Neighbor Pharmacy Tussin®
  • Good Sense Tussin®
  • Guiatuss®
  • Iophen NR®
  • Kids-EEZE®
  • Leader Adult Tussin®
  • Leader Mucus Relief®
  • Liqufruta®
  • Little Remedies Little Colds Mucus Relief Expectorant Melt Aways®
  • MucaPlex®
  • Mucinex®
  • Mucinex for Kids®
  • Mucus Relief®
  • Mucus Relief Chest®
  • ORGAN-I NR®
  • Premier Value Chest Congestion Relief®
  • Q-Tussin®
  • Refenesen® Chest Congestion Relief
  • Robitussin® Chest Congestion
  • Scot-Tussin® Expectorant SF Cough
  • SelectHealth Tussin DM®
  • Siltussin DAS®
  • Siltussin SA®
  • Smart Sense Tussin®
  • Sunmark Tussin®
  • Topcare Mucus Relief®
  • Topcare Tussin®
  • Tussin®
  • Tussin Chest®
  • Tussin Chest Congestion®
  • Tussin Original®
  • Up and Up Childrens Mucus Relief®
  • Vicks® DayQuil®
  • Wal Tussin®
  • Adult Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Aldex® (as a combination product containing Guaifenesin, Pseudoephedrine)
  • Biocotron® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Biospec® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Bisolvine® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Care One Chest Congestion Relief® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Certuss® (as a combination product containing Chlophedianol, Guaifenesin)
  • Cheratussin AC® (as a combination product containing Codeine, Guaifenesin)
  • chest congestion® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Childrens Mucus Relief® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Childrens Mucus Relief Cherry® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Childrens Mucus Relief Cough Cherry® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Childrens Relief Cherry® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Chlo Tuss® (as a combination product containing Chlophedianol, Guaifenesin)
  • Codar® (as a combination product containing Codeine, Guaifenesin)
  • Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Cough Syrup® (as a combination product containing Dextromethorphan, Guaifenesin)
  • CounterAct® (as a combination product containing Dextromethorphan, Guaifenesin)
  • CVS Chest Congestion Relief® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Dex-Tuss® (as a combination product containing Codeine, Guaifenesin)
  • DG Health Childrens Mucus Relief Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
  • DG Health Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Diabetic Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Diabetic Tussin DM Maximum Strength® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Donatussin Drops® (as a combination product containing Guaifenesin, Phenylephrine)
  • Double Tussin Intense Cough Reliever® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Equaline Adult Tussin® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Equaline Tussin Cough and Chest Congestion® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Equate Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Expectorant Plus Cough Relief® (as a combination product containing Dextromethorphan, Guaifenesin)
  • FormuCare Cough Syrup DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Freds Chest Congestion Relief® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Good Neighbor Pharmacy Adult Tussin® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Good Neighbor Pharmacy Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Good Neighbor Pharmacy Tussin DM Max® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Good Sense Childrens Mucus Relief Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Good Sense tussin® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Good Sense Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Guaiasorb DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Guaiatussin AC® (as a combination product containing Codeine, Guaifenesin)
  • Guiatuss DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Healthy Accents Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Iophen C NR® (as a combination product containing Codeine, Guaifenesin)
  • Iophen DM NR® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Leader Adult Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Leader Childrens Mucus Relief Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Leader Intense Cough Reliever® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Leader Tussin DM Max® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Lusair® (as a combination product containing Guaifenesin, Phenylephrine)
  • Mucinex Fast-Max® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Mucus Relief Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Mucus Relief DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Nature Fusion® (as a combination product containing Dextromethorphan, Guaifenesin)
  • PediaCare Childrens Cough and Congestion® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Premier Value Chest Congestion and Cough Relief® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Primatene® (as a combination product containing Ephedrine, Guaifenesin)
  • Q Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • RelCof-C® (as a combination product containing Codeine, Guaifenesin)
  • Robafen DM Max® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Robitussin Cough and Chest Congestion DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Safetussin® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Scot-Tussin Senior SF DMExp® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Smart Sense Mucus Relief Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Smart Sense tussin dm max® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Sun Mark Mucus Relief Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Sun Mark Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Sunmark Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Topcare Mucus Relief® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Topcare tussin dm® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Topcare Tussin DM Max® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Tussin Cough DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Up and Up Adult Cough Formula DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Up and Up Childrens Mucus Relief and Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Vanacof® (as a combination product containing Chlophedianol, Guaifenesin)
  • Vicks® DayQuil® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Wal Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Z-Cof 1® (as a combination product containing dextromethorphan and Guaifenesin, Pseudoephedrine)
  • Zicam® (as a combination product containing acetaminophen and Dextromethorphan, Guaifenesin)
  • Zodryl DEC® (as a combination product containing pseudoephedrine and Codeine, Guaifenesin)
  • Zyncof® (as a combination product containing Dextromethorphan, Guaifenesin)
  • Also available generically

All EBSCO Publishing proprietary, consumer health and medical information found on this site is accredited by URAC. URAC's Health Web Site Accreditation Program requires compliance with 53 rigorous standards of quality and accountability, verified by independent audits. To send comments or feedback to our Editorial Team regarding the content please email us at HLEditorialTeam@ebscohost.com.

This content is reviewed regularly and is updated when new and relevant evidence is made available. This information is neither intended nor implied to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with questions regarding a medical condition.

Editorial Policy | Privacy Policy | Terms and Conditions | Support
Copyright © 2008 EBSCO Publishing. All rights reserved.

Create joy and satisfaction. Positive emotions can boost your ability to bounce back from stress.