Label: MAXIMUM STRENGTH MUCUS RELIEF- guaifenesin tablet, extended release

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

Drug Label Information

Updated September 17, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT(in each extended-release tablet)

    Guaifenesin 1200 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 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 to 25°C (68 to 77°F)
  • INACTIVE INGREDIENT SECTION

    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. 

  • HOW SUPPLIED

    Product: 63629-8348

    NDC: 63629-8348-1 28 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 63629-8348-2 180 TABLET, EXTENDED RELEASE in a BOTTLE

  • Guaifenesin ER 1200mg Tablet

    Label Image
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MUCUS RELIEF 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-8348(NDC:69230-315)
    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 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code G234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63629-8348-128 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
    2NDC:63629-8348-2180 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20921511/06/2019
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(63629-8348) , RELABEL(63629-8348)