Label: BETR REMEDIES CHEST CONGESTION RELIEF- guaifenesin tablet, multilayer, extended release

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

Drug Label Information

Updated March 20, 2023

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  • 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 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

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

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

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    BETR remedies™

    Same Relief. BETR Mission.

    chest congestion relief

    Guaifenesin Extended-Release Tablets 1200 mg

    Expectorant

    Maximum Strength

    12 Hour

    Relieves Chest Congestion

    Thins & Loosens Mucus

    Immediate & Extended-Release

    Compare to Maximum Strength Mucinex® active ingredient

    …. If you ‘re comparing.

    14 EXTENDED-RELEASE TABLETS

    betr remedies chest congestion relief-image
  • INGREDIENTS AND APPEARANCE
    BETR REMEDIES CHEST CONGESTION RELIEF 
    guaifenesin tablet, multilayer, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80267-010
    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 OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code G;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80267-010-7414 in 1 CARTON03/20/2023
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21342003/20/2023
    Labeler - Live Betr LLC (117423281)
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