Label: MUCUS RELIEF- guaifenesin tablet

  • NDC Code(s): 68210-0116-1
  • Packager: SPIRIT PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 18, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)                           

    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

    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

  • Directions

    • do not crush, chew, or break caplet
    • take with a full glass of water
    • adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 caplets in 24 hours.
    • children under 12 years of age: do not use
  • Other information

    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    Colloidal sillicone dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    GREENBRIER INTERNATIONAL, INC.
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

  • PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton

    ASSURED™

    EXPECTORANT

    MUCUS 

    RELIEF

    • Guaifenesin 400 mg

    Thins &

    Loosens

    Mucus,

    Relieves Chest Congestion

    Actual Size

    PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0116
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code EB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0116-11 in 1 CARTON03/15/201801/12/2022
    115 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/15/2018
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LTD915664486manufacture(68210-0116)
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