Label: MUCINEX- guaifenesin tablet, extended release

  • NDC Code(s): 63824-008-15, 63824-008-17, 63824-008-24, 63824-008-27, view more
    63824-008-32, 63824-008-34, 63824-008-36, 63824-008-50, 63824-008-69, 63824-008-72, 63824-008-73, 63824-008-74, 63824-008-80, 63824-008-86, 63824-008-92
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 10, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

    Guaifenesin 600 mg

    Close
  • Purpose

    Expectorant

    Close
  • Uses

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

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

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

    carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

    Close
  • Questions?

    1-866-MUCINEX (1-866-682-4639)

    You may also report side effects to this phone number.

    Close
  • SPL UNCLASSIFIED SECTION

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

    Made in England

    Close
  • PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

    NDC 63824-008-32

    Mucinex®

    600 mg guaifenesin
    extended-release bi-layer tablets

    EXPECTORANT

    12
    HOUR®

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

    20
    EXTENDED-RELEASE
    BI-LAYER TABLETS

    Principal Display Panel - 20 Tablet Blister Pack Carton
    Close
  • INGREDIENTS AND APPEARANCE
    MUCINEX 
    guaifenesin tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-008
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 600 mg
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color WHITE (blue and white) Score no score
    Shape OVAL Size 16mm
    Flavor Imprint Code Mucinex;600
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-008-36 1 in 1 CARTON 07/03/2012
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:63824-008-32 1 in 1 CARTON 07/03/2012
    2 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:63824-008-34 2 in 1 CARTON 07/03/2012
    3 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:63824-008-69 3 in 1 CARTON 07/03/2012
    4 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:63824-008-27 4 in 1 CARTON 07/03/2012
    5 18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6 NDC:63824-008-15 5 in 1 CARTON 07/03/2012
    6 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7 NDC:63824-008-74 24 in 1 CARTON 07/03/2012
    7 NDC:63824-008-73 2 in 1 POUCH; Type 0: Not a Combination Product
    8 NDC:63824-008-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/03/2012
    9 NDC:63824-008-72 2 in 1 POUCH; Type 0: Not a Combination Product 07/03/2012
    10 NDC:63824-008-86 4 in 1 CARTON 07/03/2012
    10 17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    11 NDC:63824-008-24 2 in 1 CARTON 07/03/2012
    11 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    12 NDC:63824-008-80 4 in 1 CARTON 07/03/2012
    12 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
    13 NDC:63824-008-92 6 in 1 CARTON 07/03/2012
    13 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
    14 NDC:63824-008-17 25 in 1 CARTON 10/01/2018
    14 NDC:63824-008-72 2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021282 07/03/2012
    Labeler - RB Health (US) LLC (081049410)
    Close