Label: TOPCO MUCUS RELIEF- guaifenesin tablet, extended release

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

Drug Label Information

Updated November 28, 2022

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  • ACTIVE INGREDIENT(in each extended-release tablet)

    Guaifenesin 600 mg

  • PURPOSE

    Expectorant

  • USE(S)

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

  • WARNING

    .

  • 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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
    • children under 12 years of age: do not use
  • OTHER INFORMATION

    • tamper evident: do not use if seal on bottle printed "SEALED for YOUR PROTECTION" is torn or missing
    • store between 20 to 25°C (68 to 77°F)
  • INACTIVE INGREDIENTS

    carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

  • QUESTIONS?

    1-609-860-2600

    Hours: 8am - 4pm, EST

    You may also report side effects to this phone number. 

  • PRINCIPAL DISPLAY PANEL

    Topcare health 

    COMPARE TO MUCINEX® EXTENDED RELEASE TABLETS 600 mg - EXPECTORANT

    Mucus Relief

    GUAIFENESIN EXTENDED RELEASE TABLETS 600 mg - EXPECTORANT

    • Relieves Chest Congestion
    • Thins and Loosens Mucus

    12 Hour

    100 EXTENDED-RELEASE TABLETS


    73

  • INGREDIENTS AND APPEARANCE
    TOPCO MUCUS RELIEF 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-226
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code G233
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-226-16100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20921506/01/2021
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(36800-226)
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