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 February 9, 2023

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!