Label: MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release

  • NDC Code(s): 63824-023-02, 63824-023-07, 63824-023-18, 63824-023-35, view more
    63824-023-36, 63824-023-46, 63824-023-48, 63824-023-56
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 16, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each extended-release bi-layer tablet)

    Guaifenesin 1200 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.

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

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

    carbomer homopolymer type B; FD&C blue no. 1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

  • Questions?

    1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

    Made in England

  • PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

    NDC 63824-023-35

    MAXIMUM STRENGTH

    Mucinex®
    1200 mg guaifenesin
    extended-release bi-layer tablets

    EXPECTORANT

    12
    HOUR®

    🗸
    Relieves Chest Congestion
    🗸
    Thins and Loosens Mucus
    🗸
    Immediate and Extended Release

    14
    EXTENDED-RELEASE
    BI-LAYER TABLETS

    PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX   MAXIMUM STRENGTH
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    aluminum oxide (UNII: LMI26O6933)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (blue and white) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code Mucinex;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-023-071 in 1 CARTON06/11/2015
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63824-023-351 in 1 CARTON06/26/2012
    214 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63824-023-362 in 1 CARTON06/26/2012
    314 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:63824-023-484 in 1 CARTON06/26/2012
    412 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:63824-023-463 in 1 CARTON06/26/2012
    514 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:63824-023-182 in 1 CARTON06/26/201206/15/2022
    69 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:63824-023-021 in 1 CARTON07/01/2021
    71 in 1 POUCH; Type 0: Not a Combination Product
    8NDC:63824-023-564 in 1 CARTON07/01/2021
    814 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02128206/26/2012
    Labeler - RB Health (US) LLC (081049410)
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