PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Advertisement
  • CLASSES

    Expectorants

    DEA CLASS

    OTC

    DESCRIPTION

    Oral expectorant used for cough to loosen and aid in the clearance of mucus
    Not beneficial for cough suppression
    Available in nonprescription (OTC) and prescription products

    COMMON BRAND NAMES

    AllFen, Altarussin, Altorant, Ambi, Amibid LA, Bidex, Cough, Diabetic Tussin EX, Diabetic Tussin Mucus Relief, Drituss G, Duratuss G, ElixSure EX, Fenesin, Ganidin NR, GERI-TUSSIN, Gua SR, Guaidrine G, Guaifenex G, Guaifenex LA, Guiatuss, Humibid E, Humibid LA, Iophen-NR, Liquibid, Mucinex, Mucinex Children's, Mucinex Junior Strength, Muco-Fen, Mucosa, Mucus ER, Mucus Relief, Mucus Relief Children's, MucusRelief DM, Organ-1 NR, Organidin NR, Q-Bid LA, Q-Tussin, Respa-GF, Robafen, Robitussin, Robitussin Mucus + Chest Congestion, Scot-Tussin Expectorant, Siltussin DAS, Siltussin Diabetic DAS-Na, Siltussin SA, Xpect

    HOW SUPPLIED

    AllFen/Bidex/Diabetic Tussin Mucus Relief/Guaifenesin/Humibid E/Liquibid/Mucosa/Mucus Relief/MucusRelief DM/Organ-1 NR/Organidin NR/Xpect Oral Tab: 200mg, 400mg
    Altarussin/Altorant/Cough/Diabetic Tussin EX/Diabetic Tussin Mucus Relief/ElixSure EX/Ganidin NR/GERI-TUSSIN/Guaifenesin/Guiatuss/Iophen-NR/Mucinex Children's/Mucus Relief Children's/Organidin NR/Q-Tussin/Robafen/Robitussin/Robitussin Mucus + Chest Congestion/Scot-Tussin Expectorant/Siltussin DAS/Siltussin Diabetic DAS-Na/Siltussin SA Oral Sol: 5mL, 10mL, 50mg, 100mg, 200mg
    Altarussin/Altorant/Cough/Diabetic Tussin EX/Ganidin NR/GERI-TUSSIN/Guaifenesin/Guiatuss/Iophen-NR/Mucinex Children's/Mucus Relief Children's/Organidin NR/Q-Tussin/Robafen/Robitussin/Robitussin Mucus + Chest Congestion/Scot-Tussin Expectorant/Siltussin DAS/Siltussin Diabetic DAS-Na/Siltussin SA Oral Liq: 5mL, 100mg
    Ambi/Amibid LA/Drituss G/Duratuss G/Fenesin/Gua SR/Guaidrine G/Guaifenesin/Guaifenex G/Guaifenex LA/Humibid LA/Liquibid/Mucinex/Muco-Fen/Mucus ER/Q-Bid LA/Respa-GF Oral Tab ER: 600mg, 1200mg
    Cough/GERI-TUSSIN/Guaifenesin/Guiatuss/Q-Tussin/Robafen/Robitussin/Siltussin SA Oral Syrup: 5mL, 100mg
    Mucinex Junior Strength Oral Gran: 100mg

    DOSAGE & INDICATIONS

    For the treatment of cough associated with colds and minor upper respiratory tract infections and for loosening phlegm and thin bronchial secretions to aid in clearing bronchial passages and making coughs more productive.
    Oral dosage (immediate-release capsules or tablets)
    Adults, Adolescents, and Children 12 years and older

    200 to 400 mg PO every 4 hours as needed. Max: 6 doses/day (2400 mg/day).

    Oral dosage (extended-release or biphasic capsules or tablets)
    Adults, Adolescents, and Children 12 years and older

    600 to 1200 mg PO every 12 hours as needed. Max: 2400 mg/day PO.

    Oral dosage (oral solutions or syrups)
    Adults and Adolescents

    200 to 400 mg PO every 4 hours as needed. Max: 2400 mg/day PO.

    Children 6 to 11 years

    100 to 200 mg PO every 4 hours as needed. Max: 1200 mg/day PO.

    Children 2 to 5 years

    50 to 100 mg PO every 4 hours as needed. Max: 600 mg/day PO.

    Oral dosage (oral granule packets with guaifenesin 100 mg per packet; e.g., Mucinex Children's Chest Congestion Expectorant Mini-Melts)
    Adults, Adolescents, and Children 12 years and older

    2 to 4 packets PO every 4 hours as needed. Do not exceed 6 doses/24 hours.

    Children 6 to 11 years

    1 to 2 packets PO every 4 hours as needed. Do not exceed 6 doses/24 hours.

    Children 4 to 5 years

    1 packet PO every 4 hours as needed. Do not exceed 6 doses/24 hours.

    For the treatment of cervical factor infertility†, including cervical mucus thickening induced by clomiphene treatment.
    Oral dosage (immediate release, alcohol-free formulations)
    Adult non-pregnant females

    A dosage of 200 mg PO 3 times daily during the follicular phase of the menstrual cycle (i.e., until ovulation) has been reported to be effective at thinning cervical secretions for the purpose of enhancing sperm penetration. When used with clomiphene treatment, guaifenesin use typically follows the last dose of clomiphene and continues until ovulation. Although widely reported as a potential usage, no controlled clinical trials exist. Use for this purpose is limited to the prescription by a qualified fertility specialist. Alcohol-free products should be chosen.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    2400 mg/day PO.

    Geriatric

    2400 mg/day PO.

    Adolescents

    2400 mg/day PO.

    Children

    12 years: 2400 mg/day PO.
    6 to 11 years: 1200 mg/day PO.
    2 to 5 years: 600 mg/day PO.
    Less than 2 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment is needed. Guaifenesin is primarily renally eliminated.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Oral Administration

    To assist expectoration, patients should have an adequate intake of fluids while taking guaifenesin.

    Oral Solid Formulations

    Extended-release tablets: Swallow whole; do not crush, break, or chew. Take with a full glass of water. May be given with or without food.
    Oral granules: Open packet, sprinkle entire contents onto tongue, and swallow. For best taste, do not chew granules. Liquid is not necessary for administration.

    Oral Liquid Formulations

    Oral solutions: Administer using a calibrated measuring device to ensure accurate dosage.

    STORAGE

    Generic:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    AllFen:
    - Avoid excessive heat (above 104 degrees F)
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    - Store in a dry place
    Altarussin :
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Altorant :
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Ambi:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Amibid LA :
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Bidex:
    - Avoid excessive heat (above 104 degrees F)
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    - Store in a dry place
    Cough :
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Diabetic Tussin EX:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Diabetic Tussin Mucus Relief:
    - Avoid excessive heat (above 104 degrees F)
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    - Store in a dry place
    Drituss G:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Duratuss G:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    ElixSure EX:
    - Protect from freezing
    - Protect from light
    - Store at room temperature (between 59 to 86 degrees F)
    Fenesin :
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Ganidin NR:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    GERI-TUSSIN:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Gua SR :
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Guaidrine G:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Guaifenex G:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Guaifenex LA:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Guiatuss:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Humibid:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Humibid E:
    - Avoid excessive heat (above 104 degrees F)
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    - Store in a dry place
    Humibid LA:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Iophen-NR :
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Liquibid:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Mucinex:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Mucinex Children's:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Mucinex Children's Mini-Melts:
    - Store at room temperature (between 59 to 86 degrees F)
    Mucinex Junior Strength:
    - Store between 59 to 77 degrees F
    Muco-Fen:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Mucosa:
    - Avoid excessive heat (above 104 degrees F)
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    - Store in a dry place
    Mucus ER:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Mucus Relief:
    - Avoid excessive heat (above 104 degrees F)
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    - Store in a dry place
    Mucus Relief Children's:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    MucusRelief DM:
    - Avoid excessive heat (above 104 degrees F)
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    - Store in a dry place
    Naldecon:
    - Protect from freezing
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Organ-1 NR:
    - Store at room temperature (between 59 to 86 degrees F)
    Organidin NR:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Q-Bid LA:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Q-Tussin:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Respa-GF:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Robafen :
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Robitussin:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Robitussin Mucus + Chest Congestion:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Scot-Tussin Expectorant:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Siltussin DAS:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Siltussin Diabetic DAS-Na :
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Siltussin SA:
    - Do not refrigerate
    - Store between 68 to 77 degrees F
    Xpect:
    - Avoid excessive heat (above 104 degrees F)
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    - Store in a dry place

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Guaifenesin may alter some laboratory tests. It may increase renal clearance for urate and lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic acid and may therefore interfere with the interpretation of this diagnostic test for carcinoid syndrome. Guaifenesin may also falsely elevate the VMA test for catechols. Guaifenesin should be discontinued at least 48 hours prior to the collection of urine specimens for such laboratory tests.

    Asthma, bronchitis, emphysema, heart failure, tobacco smoking

    Guaifenesin should not be used for persistent or chronic cough such as occurs with tobacco smoking, asthma, emphysema, or chronic bronchitis or any other condition where cough is associated with excessive secretions, unless under the supervision of a health care professional. Guaifenesin should not be used for a cough that is specifically associated with heart failure or ACE inhibitor therapy.

    Fever

    A fever may be indicative of a serious condition. Guaifenesin should be used in patients with a high temperature only under the direction of a physician.

    Children, infants

    Guaifenesin products are not recommended for use in children and infants less than 2 years of age due to lack of evidence for safety and efficacy. In January 2007, the CDC warned caregivers and healthcare providers of the risk for serious injury or fatal overdose from the administration of cough and cold products to children and infants less than 2 years of age. The report estimated that 1,519 children less than 2 years of age were treated in emergency departments during 2004 to 2005 for adverse events related to cough and cold medications; some cases were due to inadvertent inappropriate use. In October 2007, the FDA Nonprescription Drug Advisory Committee and the Pediatric Advisory Committee recommended that nonprescription cough and cold products containing pseudoephedrine, dextromethorphan, chlorpheniramine, diphenhydramine, brompheniramine, phenylephrine, clemastine, or guaifenesin not be used in children less than 6 years of age. In January 2008, the FDA issued a Public Health Advisory recommending that OTC cough and cold products not be used in infants and children less than 2 years. For use of guaifenesin products in children, labels should be read carefully, caution should be used when administering multiple products, and only measuring devices specifically designed for use with medications should be used. Clinicians should thoroughly assess each patient's use of similar products, both prescription and nonprescription, to avoid duplication of therapy and the potential for inadvertent overdose.

    Pregnancy

    Safe use of guaifenesin in pregnancy has not been established and it is not clear if the drug crosses the placenta; guaifenesin should be given to a pregnant woman only if clearly needed. Few studies have been done to evaluate the use of expectorants during pregnancy and thus first trimester use is best avoided. Increased fluids to ease expectoration are usually recommended for first line treatment in the pregnant woman. When the drug must be administered to a pregnant woman, choose guaifenesin product formulations that are alcohol-free.

    Breast-feeding

    It is not known if guaifenesin is excreted into breast milk and, according to the manufacturer, it should be given cautiously to women who are breast-feeding since the effects on a nursing infant have not been formally studied. According to experts, however, it is unlikely that with usual maternal guaifenesin doses or amounts in breast milk would harm the nursing infant, especially in an infant over 2 months of age. Increased fluids to ease expectoration are usually recommended for first line treatment in the mother. If use of guaifenesin is necessary, it is best to avoid the use of guaifenesin products with a high alcohol content; check product ingredients. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    Geriatric

    There are no particular precautions for the use of guaifenesin in the ambulatory, non-debilitated geriatric patient compared to use in younger adults. The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents (e.g., geriatric adults) of long-term care facilities. According to the OBRA guidelines, cough, cold, and allergy medications should be used only for a limited duration (less than 14 days) unless there is documented evidence of enduring symptoms that cannot otherwise be alleviated and for which a cause cannot be identified and corrected.

    ADVERSE REACTIONS

    Moderate

    nephrolithiasis / Delayed / Incidence not known

    Mild

    headache / Early / Incidence not known
    diarrhea / Early / Incidence not known
    abdominal pain / Early / Incidence not known
    vomiting / Early / Incidence not known
    nausea / Early / Incidence not known
    rash (unspecified) / Early / Incidence not known
    dizziness / Early / Incidence not known
    drowsiness / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Guaifenesin products.

    PREGNANCY AND LACTATION

    Pregnancy

    Safe use of guaifenesin in pregnancy has not been established and it is not clear if the drug crosses the placenta; guaifenesin should be given to a pregnant woman only if clearly needed. Few studies have been done to evaluate the use of expectorants during pregnancy and thus first trimester use is best avoided. Increased fluids to ease expectoration are usually recommended for first line treatment in the pregnant woman. When the drug must be administered to a pregnant woman, choose guaifenesin product formulations that are alcohol-free.

    It is not known if guaifenesin is excreted into breast milk and, according to the manufacturer, it should be given cautiously to women who are breast-feeding since the effects on a nursing infant have not been formally studied. According to experts, however, it is unlikely that with usual maternal guaifenesin doses or amounts in breast milk would harm the nursing infant, especially in an infant over 2 months of age. Increased fluids to ease expectoration are usually recommended for first line treatment in the mother. If use of guaifenesin is necessary, it is best to avoid the use of guaifenesin products with a high alcohol content; check product ingredients. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Guaifenesin loosens and thins phlegm and bronchial secretions to ease expectoration. By reducing the viscosity and adhesiveness of secretions, guaifenesin increases the efficacy of the mucociliary mechanism in removing accumulated secretions from the upper and lower airway. The increased flow of less viscous secretions promotes ciliary action and changes a dry, unproductive cough to one that is more productive and less frequent. Guaifenesin can also be beneficial for irritating, nonproductive coughs and for conditions in which thick mucous secretions are produced.

    PHARMACOKINETICS

    Guaifenesin is administered orally. The plasma half-life is approximately 1 hour. Guiafenesin is rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite. No unchanged drug was detected in the urine following administration. Renal stones that developed during drug therapy have been documented to contain beta-(2-methoxyphenoxy)-lactic acid and other guaifenesin metabolites. Other pharmacokinetic parameters of guaifenesin are not known.

    Oral Route

    Guaifenesin is rapidly and well absorbed from the gastrointestinal tract. Extended release products (e.g., Humibid LA) release drug slowly over a period of several hours, allowing for less frequent dosing. The Mucinex brand tablet, a combination immeditate-release/extended-release product, utilizes a patented bilayer delivery system which releases guaifenesin immediately from the first layer and over 12 hours from the second layer. Guaifenesin has a plasma half-life of approximately 1 hour.