Organidin NR (Guaifenesin)
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Organidin NR (Guaifenesin)

ORGANIDIN NR
(guaifenesin) Tablet and Liquid

DRUG DESCRIPTION

Guaifenesin (glyceryl guaiacolate) has the chemical name 3-(2-methoxyphenoxy)-1,2-propanediol. Its molecular formula is C10H14O4 with a molecular weight of 198.21. It is a white or slightly gray crystalline substance with a slightly bitter aromatic taste. One gram dissolves in 20 mL water at 25°C; it is freely soluble in ethanol. Guaifenesin is readily absorbed from the GI tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is b-(2-methoxyphenoxy) lactic acid.

ORGANIDIN® NR (guaifenesin) is an expectorant available for oral administration as:

Tablets — each containing 200 mg guaifenesin, USP.

Other ingredients: Corn starch, croscarmellose sodium, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose.

What are the possible side effects of guaifenesin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • dizziness or headache,
  • a rash, or
  • nausea, vomiting, or stomach upset.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Organidin NR »

What are the precautions when taking guaifenesin (Organidin NR)?

Before taking this medication, 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: breathing problems (such as emphysema, chronic bronchitis, asthma, smoker's cough), cough with blood or large amounts of mucus.

Liquid forms of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, liver disease, 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

The liquid...

Read All Potential Precautions of Organidin NR »

Last reviewed on RxList: 1/22/2013
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes and make coughs more productive. Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis.

DOSAGE AND ADMINISTRATION

ORGANIDIN® NR (guaifenesin)

Tablets — Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.

PATIENTS SHOULD BE ADVISED TO KEEP THESE AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.

HOW SUPPLIED

ORGANIDIN® NR (guaifenesin)

Tablets — Each round, scored, rose-colored tablet contains 200 mg guaifenesin USP—available in bottles of 100 (NDC 0037-4312-01)

Storage

Store at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120. Rev. 11/09

Last reviewed on RxList: 1/22/2013
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Guaifenesin is well tolerated and has a wide margin of safety. Side effects have been generally mild and infrequent. Nausea and vomiting are the side effects that occur most commonly. Dizziness, headache, and rash (including urticaria) have been reported rarely.

Read the Organidin NR (guaifenesin) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Laboratory Test Interactions

Guaifenesin or its metabolites may cause color interference with the VMA (vanillylmandelic acid) test for catechols. It may also falsely elevate the level of urinary 5-HIAA (5-hydroxyindoleacetic acid) in certain serotonin metabolite chemical tests because of color interference.

Last reviewed on RxList: 1/22/2013
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy

Teratogenic Effects - Pregnancy Category C

Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, these products should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards.

Nursing Mothers

It is not known whether guaifenesin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these products are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Last reviewed on RxList: 1/22/2013
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

In massive overdosage the stomach should be emptied (emesis and/or gastric lavage) and further absorption prevented. Treatment is symptomatic and supportive.

The acute toxicity of guaifenesin is low and overdosage is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when guaifenesin was administered by stomach tube in doses up to 5 grams/kg.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients.

Last reviewed on RxList: 1/22/2013
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

ORGANIDIN® NR (guaifenesin) is an expectorant, the action of which promotes or facilitates the removal of secretions from the respiratory tract. By increasing sputum volume and making sputum less viscous, guaifenesin facilitates expectoration of retained secretions.

Last reviewed on RxList: 1/22/2013
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/22/2013
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/22/2013
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Organidin NR Consumer

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 - ORAL

(gwye-FEN-e-sin)

COMMON BRAND NAME(S): Guiatuss, Organidin NR, Robitussin

USES: Guaifenesin is used to treat coughs and congestion caused by the common cold, bronchitis, 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.

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. To decrease the risk for 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, usually every 4 hours. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist.

Guaifenesin may have a bitter taste. Do not split the 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 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.

For powder packets, empty the entire contents of the packet onto the tongue and swallow. To prevent a bitter taste, do not chew.

Dosage is based on your age, medical condition, and response to treatment. Do not take more than 6 doses in a day. Do not increase your dose or take this drug more often than directed.

Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.

Tell your doctor if your cough 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.

Disclaimer

Organidin NR Consumer (continued)

SIDE EFFECTS: Nausea or vomiting 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. Most people using this medication do not have serious side effects.

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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Organidin NR (guaifenesin) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking this medication, 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: breathing problems (such as emphysema, chronic bronchitis, asthma, smoker's cough), cough with blood or large amounts of mucus.

Liquid forms of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, liver disease, 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

The liquid forms and powder packets of this medication 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 about using this product safely.

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

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

It is unknown if guaifenesin passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

Disclaimer

Organidin NR Consumer (continued)

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.

Guaifenesin is 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.

This product 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.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

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 and resume your usual dosing schedule. 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 May 2010. Copyright(c) 2010 First Databank, Inc.

Organidin NR Patient Information Including Side Effects

Brand Names: Duratuss G, Ganidin NR, GG 200 NR, Guaifenesin LA, Liquibid, Muco-Fen 1200, Organidin NR, Q-Bid LA, Robitussin, Scot-Tussin

Generic Name: guaifenesin (Pronunciation: gwye FEN e sin)

What is guaifenesin (Organidin NR)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Guaifenesin is used to reduce chest congestion caused by the common cold, infections, or allergies.

Guaifenesin may also be used for purposes not listed in this medication guide.

Duratuss G

oblong, white, imprinted with ucb 620

Guaifenesin LA 600 mg-URL

oblong, green, imprinted with MP 423

Guaifenesin LA-CAR

oblong, green, imprinted with CARACO, 152

Humibid LA

oblong, green, imprinted with MEDEVA, 012

Liquibid 600 mg

oblong, white, imprinted with LIQU IBID

What are the possible side effects of guaifenesin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • dizziness or headache,
  • a rash, or
  • nausea, vomiting, or stomach upset.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Organidin NR (guaifenesin) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about guaifenesin?

You should not use this medicine if you are allergic to guaifenesin.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Side Effects Centers

Organidin NR Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking guaifenesin?

You should not use this medicine if you are allergic to guaifenesin.

FDA pregnancy category C. It is not known whether guaifenesin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether guaifenesin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take guaifenesin?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

Take guaifenesin with food if it upsets your stomach.

Measure the liquid form of guaifenesin with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Store at room temperature away from moisture, heat, and direct sunlight.

Side Effects Centers

Organidin NR Patient Information including If I Miss a Dose

What happens if I miss a dose?

Since cough medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking guaifenesin?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect guaifenesin ?

There may be other drugs that can interact with guaifenesin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about guaifenesin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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