Label: MUCUS RELIEF- guaifenesin tablet

  • NDC Code(s): 59726-107-15, 59726-107-30
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 26, 2021

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  • Active ingredient (in each tablet)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

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

  • Warnings

    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 condition.

    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 exceed 6 tablets in 24 hours
    • take with a full glass of water
    • adults and children 12 years of age and older:
      •  take 1 tablet every 4 hours while symptoms persist.
    • children under 12 years of age: do not use 
  • Other information

    • each tablet contains: sodium 5 mg
    • store between 20-25ºC (68-77ºF)
  • Inactive ingredients

    colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

  • Questions or comments?

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

  • Principal Display Panel

    Immediate Acting Mucus Relief

    Guaifenesin 400 mg

    Expectorant

    • Relieves Chest Congestion
    • Thins and Loosens Mucus

    Tablets

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

  • Product Label

    Guaifenesin 400 mg

    READYinCASE Mucus relief

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-107
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize13mm
    FlavorImprint Code TCL272;G1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-107-151 in 1 BOX12/07/201204/26/2024
    115 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59726-107-301 in 1 BOX12/07/201204/26/2024
    230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/07/201204/26/2024
    Labeler - P & L Development, LLC (800014821)
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