Label: MUCUS RELIEF EXTENDED RELEASE- guaifenesin tablet

  • NDC Code(s): 0536-1163-61
  • Packager: Rugby Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 16, 2022

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  • Active ingredient (in each extended-release tablet)

    Guaifenesin 600 mg

  • Purpose

    Expectorant

  • Uses

    Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

  • 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 accopanied 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).

  • 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: 1 or 2 tablet every 12 hours. Do not exceed 4 tablets in 24 hours.
    • children under 12 years of age: do not use 
  • Other information

    • store between 20º to 25ºC (68º to 77ºF)
  • Inactive ingredients

    carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Mucinex®*

    Mucus Relief

    Guaifenesin  600 mg

    Expectorant

    12-hour relief

    Relieves chest congestion

    Thins and loosens mucus

    Extended-release tablets

    *This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex®.

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by:

    Rugby Laboratories

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

  • Package Label

    Guaifenesin 600 mg

    RUGBY Mucus Relief

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF EXTENDED RELEASE 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1163
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code AN036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1163-61100 in 1 CARTON08/31/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20734208/31/2018
    Labeler - Rugby Laboratories, Inc. (079246066)
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