Label: SUNMARK MUCUS ER- guaifenesin tablet, extended release 

  • NDC Code(s): 49348-905-47, 49348-905-59
  • Packager: McKesson
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/14

If you are a consumer or patient please visit this version.

  • Active ingredient (in each extended-release tablet)

    Guaifenesin 600 mg

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  • Purpose

    Expectorant

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  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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  • Warnings

    Do not use

    for children under 12 years of age

    Ask a doctor before use if you have

    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    cough accompanied by too much phlegm (mucus)

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    do not crush, chew, or break tablet
    take with a full glass of water
    this product can be administered without regard for the timing of meals
    adults and children 12 years of age and over: one or two tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
    children under 12 years of age: do not use
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  • Other information

    do not use if printed seal under cap is broken or missing
    store between 20-25°C (68-77°F)
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  • Inactive ingredients

    compressible sugar, copovidone, hydroxyethyl cellulose, silicon dioxide, zinc stearate

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    COMPARE TO MUCINEX® ACTIVE INGREDIENT

    mucus•ER

    Guaifenesin Extended-Release Tablets, 600 mg

    Expectorant

    Relieves chest congestion

    Thins & loosens mucus

    12 HOUR

    ACTUAL SIZE

    GLUTEN FREE

    40 EXTENDED-RELEASE TABLETS

    Mucus ER Carton Image 1
    Mucus ER Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    SUNMARK MUCUS ER 
    guaifenesin tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-905
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 600 mg
    Inactive Ingredients
    Ingredient Name Strength
    COPOVIDONE K25-31  
    SILICON DIOXIDE  
    ZINC STEARATE  
    Product Characteristics
    Color WHITE ((off-white)) Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code L498
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-905-47 1 in 1 CARTON
    1 20 in 1 BOTTLE
    2 NDC:49348-905-59 1 in 1 CARTON
    2 40 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078912 03/18/2013
    Labeler - McKesson (177667227)
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