GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [KROGER COMPANY]

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GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [KROGER COMPANY]
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NDC 30142-706-14, 30142-706-28
Set ID 3976d0dc-1f74-4d5e-a5b8-0a3e3ce5cfc3
Category HUMAN OTC DRUG LABEL
Packager KROGER COMPANY
Generic Name
Product Class
Product Number
Application Number NDA021620
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release tablet)Purposes

    Dextromethorphan HBr 60 mg

    Cough suppressant

    Guaifenesin 1200 mg

    Expectorant
  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    •
    temporarily relieves:
    •
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    •
    the intensity of coughing
    •
    the impulse to cough to help you get to sleep
  • Warnings

    Do not use

    •
    for children under 12 years of age
    •
    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

    •
    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

    •
    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 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

    •
    Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
    •
    store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

  • Questions or comments?

    1-800-632-6900

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY THE KROGER CO.
    CINCINNATI, OHIO 45202

  • PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

    COMPARE TO the active ingredients of
    MAXIMUM STRENGTH MUCINEX® DM *See back panel

    NDC 30142-706-14

    Kroger®

    OUR PHARMACIST RECOMMENDED

    Maximum Strength

    Mucus Relief
    ER DM - Max

    Guaifenesin 1200 mg &
    Dextromethorphan HBr 60 mg
    Extended-Release
    Tablets

    EXPECTORANT &
    COUGH SUPPRESSANT

    12
    HOUR

    • Controls Cough
    • Thins & Loosens Mucus
    • Immediate & Extended Release

    actual
    size

    14 EXTENDED-RELEASE
    TABLETS

    PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-706
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code xeunciM;1200;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-706-141 in 1 CARTON09/05/2017
    114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:30142-706-282 in 1 CARTON09/05/2017
    214 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02162009/05/2017
    Labeler - KROGER COMPANY (006999528)
    Establishment
    NameAddressID/FEIBusiness Operations
    RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(30142-706) , LABEL(30142-706)
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