Label: GUAIFENESIN EXTENDED-RELEASE 600 MG- guaifenesin tablet, extended release
GUAIFENESIN EXTENDED-RELEASE 1200 MG- guaifenesin tablet, extended release

  • NDC Code(s): 53041-233-30, 53041-233-32, 53041-233-38, 53041-234-37, view more
    53041-234-47, 53041-234-58
  • Packager: Guardian Drug Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 28, 2018

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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 A ASK 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 carton is open or if printed seal on blister is broken 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.

  • 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

  • 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 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 600 MG

    NDC 53041-233-32

    GUARDIAN

    12 HOUR

    Guaifenesin

    Extended-Release

    Tablets 600 mg

    Expectorant

    Relieves Chest Congestion

    Thins and Loosens Mucus

    20 EXTENDED-RELEASE TABLETS

    600

  • PRINCIPAL DISPLAY PANEL 1200 MG

    NDC 53041-234-58

    GUARDIAN

    12 HOUR

    MAXIMUM STRENGTH

    Guaifenesin

    Extended-Release

    Tablets 1200 mg

    Expectorant

    Relieves Chest Congestion

    Thins and Loosens Mucuc

    14 EXTENDED-RELEASE TABLETS

    1200

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN EXTENDED-RELEASE 600 MG 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-233
    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 TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code G233
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-233-322 in 1 CARTON03/01/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:53041-233-301 in 1 CARTON03/01/2018
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:53041-233-384 in 1 CARTON03/01/2018
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20921503/01/2018
    GUAIFENESIN EXTENDED-RELEASE 1200 MG 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-234
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code G234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-234-582 in 1 CARTON03/01/2018
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:53041-234-374 in 1 CARTON03/01/2018
    27 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:53041-234-476 in 1 CARTON03/01/2018
    37 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20921503/01/2018
    Labeler - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(53041-233, 53041-234)
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