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

  • NDC Code(s): 43598-008-01, 43598-008-20, 43598-008-40, 43598-009-25, view more
    43598-009-37, 43598-009-74
  • Packager: Dr. Reddy's Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 26, 2024

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  • Active ingredient(s)

    Guaifenesin 600 mg (for 600mg)

    Guaifenesin 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

    Applicable warning(s) in 201.66(c)(5)(i) and (ii)

    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 Pregnancy/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 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 1-888-375-3784 Weekdays (9am - 8pm EST)

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Dr. Reddy’s Laboratories, Inc.

    Princeton, NJ 08540

    Made in India

    I 07/2022

  • Principal Display Panel

    OTC Medicine

    Guaifenesin Extended-Release Tablets 600 mg Carton Label

    carton600

  • PRINCIPAL DISPLAY PANEL

    OTC Medicine

    Guaifenesin Extended-Release Tablets 1200 mg Carton Label

    carton1200

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 600 MG 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-008
    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:43598-008-402 in 1 CARTON03/15/2022
    1NDC:43598-008-2020 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:43598-008-015 in 1 CARTON09/01/2022
    2NDC:43598-008-2020 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:43598-009
    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:43598-009-252 in 1 CARTON03/15/2022
    1NDC:43598-009-7414 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:43598-009-373 in 1 CARTON09/01/2022
    2NDC:43598-009-7414 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 - Dr. Reddy's Laboratories Inc. (802315887)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Reddy's Laboratories Limited FTO3918608162analysis(43598-008, 43598-009) , manufacture(43598-008, 43598-009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quality Packaging Specialists International, LLC825078165pack(43598-008, 43598-009)
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