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

  • NDC Code(s): 70677-1257-1, 70677-1257-2, 70677-1258-1
  • Packager: Strategic Sourcing Services, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 9, 2024

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  • Active ingredient(s)

    Guaifenesin USP, 600 mg (for 600mg)

    Guaifenesin USP, 1200 mg (for 1200 mg)

  • Purpose

    Expectorant

  • Use(s)

    • helps loosen phlegum (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 age

    Ask a doctor before use if

    • 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 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 breastfeeding,

    ask a health professional before use.

    Keep out of reach of children

    In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222).

  • Directions

    • do not crush, chew, or break extended-release 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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg)
    • adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours (for 1200 mg)
    • children under 12 years of age: do not use
  • Other information

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

    carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

  • Questions?

    call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    McKesson Corp., via Strategic Sourcing Services LLC.

    Memphis, TN 38141

    Money Back Guarantee

    www.fosterandthrive.com

    Product of India

  • Principal Display Panel

    Guaifenesin Extended-Release Tablets 600 mg

    Carton Label

    Carton

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin Extended-Release Tablets 1200 mg

    Carton Label

    Carton

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 600 MG 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1257
    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)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Hydroxypropyl Cellulose (110000 Wamw) (UNII: 5Y0974F5PW)  
    Hypromellose 2910 (10000 Mpa.S) (UNII: 0HO1H52958)  
    Hypromellose 2208 (4000 Mpa.S) (UNII: 39J80LT57T)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorPINK (White on debossed side and Light Pink to Pink on other side ) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1257-22 in 1 CARTON02/15/2025
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70677-1257-11 in 1 CARTON02/15/2025
    220 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21593203/15/2022
    GUAIFENESIN 1200 MG 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1258
    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)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Hydroxypropyl Cellulose (110000 Wamw) (UNII: 5Y0974F5PW)  
    Hypromellose 2910 (10000 Mpa.S) (UNII: 0HO1H52958)  
    Hypromellose 2208 (4000 Mpa.S) (UNII: 39J80LT57T)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorPINK (White on debossed side and Light Pink to Pink on other side ) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code 12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1258-11 in 1 CARTON02/15/2025
    114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21593203/15/2022
    Labeler - Strategic Sourcing Services, LLC (116956644)
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