Label: GUAIFENESIN EXTENDED RELEASE- guaifenesin tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 18, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each extended-release 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 (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 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

    • 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?

    1-888-287-1915

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton

    NDC 49035-074-28

    equate™

    Compare to
    Maximum
    Strength
    Mucinex®
    Active
    Ingredient*

    Maximum Strength

    Mucus ER

    Guaifenesin Extended-Release
    Tablets 1200 mg
    Expectorant

    • Relieves chest congestion
    • Thins and loosens mucus
    • Immediate and extended-release

    12
    HOUR

    1200
    mg

    28
    EXTENDED-
    RELEASE
    TABLETS

    Actual Size

    PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN   EXTENDED RELEASE
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-074
    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)  
    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 Mxeunic;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-074-282 in 1 CARTON12/10/2017
    114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02128212/10/2017
    Labeler - WALMART STORES, INC. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(49035-074)
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