MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]

  • Home
  • MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]

MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]
PDF | XML
NDC 63824-041-24, 63824-041-36, 63824-041-71
Set ID d9264518-2f2c-498f-b733-6f3397336a01
Category HUMAN OTC DRUG LABEL
Packager RB Health (US) LLC
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number NDA021585
View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release bi-layer tablet)Purposes
    Guaifenesin 1200 mgExpectorant
    Pseudoephedrine HCl 120 mgNasal Decongestant
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves nasal congestion due to:
      • common cold
      • hay fever
      • upper respiratory allergies
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • temporarily relieves sinus congestion and pressure
  • Warnings

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)

    When using this product

    • do not use more than directed

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days, come back or occur with a 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 timing of meals
    • adults and children 12 years and older: 1 tablet every 12 hours; not more than 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 yellow #6 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 - 24 Tablet Blister Pack Carton

    MAXIMUM STRENGTH

    NDC 63824-041-24

    Mucinex®D
    1200 mg guaifenesin & 120 mg pseudoephedrine HCl
    extended-release bi-layer tablets

    EXPECTORANT
    & NASAL DECONGESTANT

    12
    HOUR®

    ✔
    Clears Nasal/Sinus Congestion
    ✔
    Thins and Loosens Mucus
    ✔
    Immediate and Extended Release

    24
    EXTENDED-RELEASE
    BI-LAYER TABLETS

    Principal Display Panel - 24 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX D   MAXIMUM STRENGTH
    guaifenesin and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 mg
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride120 mg
    Inactive Ingredients
    Ingredient NameStrength
    carbomer homopolymer type B (allyl pentaerythritol crosslinked) (UNII: HHT01ZNK31)  
    FD&C yellow NO. 6 (UNII: H77VEI93A8)  
    aluminum oxide (UNII: LMI26O6933)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    Product Characteristics
    ColorORANGE, WHITEScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code Mucinex;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-041-242 in 1 CARTON06/26/2012
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63824-041-7124 in 1 CARTON06/26/201207/10/2017
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:63824-041-363 in 1 CARTON06/26/201209/12/2017
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:63824-041-121 in 1 CARTON01/01/2020
    412 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02158506/26/2012
    Labeler - RB Health (US) LLC (081049410)
View All Sections

Related Drugs

Search DailyMed Drugs